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Title The effect of massage therapy in relieving anxiety incancer patients receiving chemotherapy
Author(s) Huen, Suk-ting; 禤淑婷
Citation
Issue Date 2013
URL http://hdl.handle.net/10722/193054
Rights The author retains all proprietary rights, (such as patentrights) and the right to use in future works.
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Abstract of dissertation entitled
The effect of massage therapy in relieving anxiety
in cancer patients receiving chemotherapy
Submitted by
Huen Suk Ting
for the degree of Master of Nursing
at The University of Hong Kong
in July 2013
Chemotherapy is one of the major treatments for cancer patients to cure or
palliate their disease. Cancer patients experience physiological and psychological
distress during chemotherapy treatment. Anxiety is the most common symptom
observed in cancer patients undergoing chemotherapy. Anxiety has also proven to be
highly associated with anticipatory nausea and vomiting (ANV). In the local
chemotherapy day ward, almost half of the cancer patients verbalize that they feel
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anxious and are afraid of turning up for chemotherapy due to the fear of its side
effects. However, clinical measure for treating patients’ anxiety during chemotherapy
is limited. One of the complementary and alternative medicines (CAM), massage
therapy, becomes a useful means for cancer patients to relieve their physical and
psychological distress. Yet, massage is not a routine CAM being integrated into the
cancer treatment in Hong Kong, including the target center. Thus, a translational
study is proposed in order to develop a massage program for cancer patients receiving
chemotherapy to relieve their anxiety.
A systematic search of five electronic journal databases identified 9
randomized controlled trials (RCTs) on the use of massage therapy for cancer patients
in relieving their anxiety. The appraisal tool developed by the Critical Appraisal Skills
Programme was used to evaluate the quality of the selected studies. The findings of
the selected studies concluded that massage therapy is effective in relieving anxiety
for cancer patients.
A massage program is proposed to be implemented in a chemotherapy day ward.
This translational research proposal will illustrate how such a massage program is
planned. The implementation potential has been assessed and the potential benefits of
massage do outweigh its risks and the costs of running this program. An
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evidence-based guideline has been developed to ensure patient safety and increase
effectiveness of the massage program.
The communication process with stakeholders has been planned in order to
gain their support for this massage program. Staff training will be organized and a
pilot study has been designed to test the feasibility of this program.
An evaluation plan has also been developed to assess the effectiveness of this
program. Anxiety level, measured by using State Trait Anxiety Inventory-State
(STAI-S), is set as the primary patient outcome of this study. In addition, Numerical
Rating Scale (NRS), rating from 0 to 10, will be used as the secondary patient
outcome to measure the severity of nausea and vomiting. Lastly, the satisfaction level
of patients, volunteers and nurses will be measured using a 4-point Likert scale.
Therefore, the proposed massage program can be improved and refined according to
the evaluation findings. It is believed that the proposed massage program can reduce
anxiety for cancer patients receiving chemotherapy and thus improving their quality
of life.
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The effect of massage therapy in relieving anxiety
in cancer patients receiving chemotherapy
by
Huen Suk Ting
Bachelor of Nursing, Registered Nurse
A dissertation submitted in partial fulfillment of the requirements for
the degree of Master of Nursing
at The University of Hong Kong
July 2013
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Declaration
I declare that this dissertation represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a theses,
dissertation or report submitted to this University or to any other institution for a
degree, diploma or other qualification.
Signed _________________________________
Huen Suk Ting
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Acknowledgements
I would like to express my heartfelt gratitude to my supervisor Miss Idy Fu, who
provided guidance and inspirations on this dissertation. Her encouragement and
support throughout these two years has enabled me to complete this dissertation.
I am also grateful to my Ward Manager, Mr. Rayman Wan and Advanced
Practice Nurse, Miss Yuen Mei-Lin, for their sincere encouragement in my
postgraduate studies.
Finally, I deeply thank my family and friends for their constant love and support
to complete this master programme.
Huen Suk Ting
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Table of contents
Declaration .................................................................................................................. v
Acknowledgements ................................................................................................... vi
Table of contents ...................................................................................................... vii
Chapter 1: Introduction ............................................................................................ 1
1.1Background ..................................................................................................... 1
1.2 Affirming the need ......................................................................................... 3
1.3 Objectives and significance ............................................................................ 5
Chapter 2: Critical Appraisal ................................................................................... 8
2.1 Search strategies ............................................................................................. 8
2.1.1 Selection criteria ...................................................................................... 8
2.2 Search results .................................................................................................. 9
2.2.1 Study characteristics ................................................................................ 9
2.2.2 Methodological assessment ................................................................... 10
2.3. Summary and synthesis of data ................................................................... 14
2.3.1 Characteristics of participants ............................................................... 14
2.3.2 Selection of participants ........................................................................ 15
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2.3.3 Dropout rate .......................................................................................... 16
2.3.4 Intervention ........................................................................................... 17
2.3.5 Type and area of massage used ............................................................. 18
2.3.6 Duration and frequency of massage ...................................................... 19
2.4 Recommendation and conclusion ................................................................. 19
Chapter 3: Translation and Application ................................................................ 23
3.1 Implementation potential .............................................................................. 23
3.1.1 Transferability of the findings ............................................................... 23
3.1.1.1 Target setting .................................................................................. 23
3.1.1.2 Target audience .............................................................................. 24
3.1.1.3 Philosophy of care .......................................................................... 25
3.1.1.4 Proposed massage intervention ...................................................... 26
3.1.2 Feasibility of the innovation .................................................................. 27
3.1.2.1 Organizational and administrative support .................................... 27
3.1.2.2 Frontline staff support .................................................................... 28
3.1.2.3 Volunteers’ support ........................................................................ 30
3.1.3 Cost/Benefit ratio of the program .......................................................... 31
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3.1.3.1 Potential risks ................................................................................. 31
3.1.3.2 Potential benefits ............................................................................ 33
3.1.3.3 Cost ................................................................................................. 34
Chapter 4: Evidence-Based Practice Guideline .................................................... 37
4.1 Aim ............................................................................................................... 37
4.2 Objectives ..................................................................................................... 37
4.3 Target population ......................................................................................... 38
4.4 Recommendations ........................................................................................ 39
Recommendation 1.0 .................................................................................. 39
Recommendation 2.0 .................................................................................. 39
Recommendation 3.0 .................................................................................. 40
Recommendation 4.0 .................................................................................. 40
Chapter 5: Implementation Plan ............................................................................ 42
5.1 Communication plan .................................................................................... 42
5.1.1 Identifying stakeholders ........................................................................ 42
5.1.2 Formation of a working group .............................................................. 43
5.1.3 Communication process ........................................................................ 44
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5.2 Staff training program .................................................................................. 46
5.3 Delivery of intervention ............................................................................... 46
5.4 Pilot study ..................................................................................................... 47
5.5 Ongoing monitoring of the massage program .............................................. 48
5.6 Evaluation plan ............................................................................................. 48
5.6.1 Identifying outcomes ............................................................................. 48
5.6.2 Nature and number of clients to be involved ........................................ 50
5.6.3 Data collection and data analysis .......................................................... 51
5.6.4 Basis for as effective change of practice ............................................... 52
Chapter 6: Conclusion ............................................................................................. 53
References ................................................................................................................. 55
Appendix A: Search history .................................................................................... 64
Appendix B: Summary of search results ............................................................... 69
Appendix C: List of selected studies ...................................................................... 70
Appendix D: Appraisal tool (RCTs checklist) ....................................................... 72
Appendix E: Level of evidence ................................................................................ 76
Appendix F: Quality assessment ............................................................................. 77
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Appendix G: Table of evidence ............................................................................... 86
Appendix H: Table of summary for the Studies’ Results .................................... 95
Appendix I: Estimated expenses that can be saved by reducing use of potent
anti-emetics ......................................................................................... 97
Appendix J: Budget plan for implementing the massage program .................... 98
Appendix K: Grade of recommendation ............................................................... 99
Appendix L: Evidence-based practice guideline of massage for cancer patients
receiving chemotherapy ................................................................... 100
Appendix M: Timetable for implementation of the massage program ............ 110
Appendix N: Assessment form for the massage program .................................. 111
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Chapter 1: Introduction
Cancer patients experience physiological and psychological distress during
chemotherapy treatment (Icomonou, et al., 2004). Anxiety is the most common
symptom observed in cancer patients undergoing chemotherapy. A
non-pharmacological method, massage therapy, is suggested for those patients to
reduce their level of anxiety, decreasing the side effects of chemotherapy and
improving their quality of life. This chapter will illustrate the needs and significance
of implementing massage interventions for cancer patients in Hong Kong in order to
reduce their anxiety.
1.1 Background
Cancer is a stressful event for patients as it is a life-threatening and chronic
illness requiring life-long monitoring for disease recurrence. According to the
Department of Health, cancer is the most leading cause of death in Hong Kong,
accounting for 31.2% of all deaths in 2009. Moreover, The Hong Kong Cancer
Registry (2007) reported that the cancer burden in our population is increasing. It is
shown by the continually rising number of new cancer cases, a rate of around 2%
every year, and the steadily increasing life expectancy for both sexes in Hong Kong in
the past 25 years. As well, the survival time for cancer patients has been lengthened
by advanced medical technology and aggressive cancer treatments (Schreier, et al.,
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2004). However, the increasing number of cancer survivors also implies a longer life
with a longer treatment period, including surgery, chemotherapy, radiotherapy and
target therapy, causing cancer patients to suffer for longer periods of and more severe
side effects from cancer treatments (Listing, et al., 2009). These lengthy treatments
can cause emotional distress for cancer patients such as anxiety, sense of guilt and
low self-esteem, due to the uncertainty of treatment and disease progression (Lin, et
al., 2011). Thus, such impact becomes an important issue for cancer patients’ quality
of life (Listing, et al., 2009).
The use of chemotherapy in cancer patients is strongly correlated with cancer
survival (Bender, et al., 2002). Chemotherapy can be classified into Curative Intent, to
eradicate tumor cells, and Palliative Intent, to decrease tumor load and symptoms so
as to prolong life. Cancer patients usually suffer from physical and psychological
problems related to fatigue, anxiety and depression during chemotherapy (Icomonou,
et al., 2004). Undesirable side effects such as nausea, vomiting, sleep disturbance and
fatigue further increase patients’ psychological distress (Lin, et al., 2011). A study
showed that 15-40% of cancer patients suffered from psychological disorders related
to anxiety and depression during chemotherapy, and that anxiety highly contributed to
the incidence of pre-therapy and post-therapy nausea and vomiting (Molassiotis, et al.,
2002).
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There has been an increase in cancer patients seeking complementary and
alternative medicine (CAM) in addition to conventional treatments to improve
common treatment side effects and disease symptoms over the past decade (DiGianni,
et al., 2002). The National Center for Complementary and Alternative Medicine
(NCCAM) (2010) defines CAM as “a group of diverse medical and health care
systems, practices, and products that are not presently considered to be part of
conventional medicine’. A survey conducted in Taiwan showed that 98.1% of cancer
patients receiving chemotherapy simultaneously used CAM such as diets, massage
and herbal medicine (Yang, et al., 2008). The Hong Kong Breast Cancer Registry
(2011) also reported that 33.5% of breast cancer patients received CAM.
Massage is one of the common CAM practices employed to relieve anxiety, pain
and nausea for cancer patients and has been widely used as a treatment for over 3000
years (Quattrin, et al., 2006). Massage is defined as ‘a rhythmic form of touch done by
a specially trained person to communicate empathy to the recipient, thus, producing
positive psychological and physiological states of being’ (Tappan, 1980).
1.2 Affirming the need
In the local chemotherapy day ward, almost half of the cancer patients admitted
for receiving chemotherapy verbalize that they feel anxious and are afraid of turning
up for chemotherapy due to the fear of its side effects. Those patients manifest anxiety
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by developing hand tremors, restlessness, nausea and vomiting before administration
of chemotherapy. This type of nausea and vomiting is referred to as ‘anticipatory
nausea and vomiting (ANV)’.
ANV is defined as developing nausea and vomiting during the 24 hour period
prior to chemotherapy administration (Andrykowski, et al., 1985). It is reported that
approximately 30% of cancer patients develop ANV before their chemotherapy
treatment (Morrow, et al., 1998). Anxiety has proven to be a significant predisposing
factor which is highly associated with ANV and is difficult to be controlled by
pharmacological treatment (Roscoe, et al., 2011). As a result, patients still experience
discomfort and suffer from chemotherapy side effects despite the use of anxiolytic
agents (Billhult, et al., 2007). Eventually, these anticipatory problems and undesirable
side effects further exaggerate the level of anxiety that is already present with the
cancer diagnosis, and therefore worsening the patient’s quality of life (Lin, et al., 2011).
Some cancer patients even refuse or defer chemotherapy due to the fear of its
associated side effects. This delay in receiving treatment then lowers their chance of
recovery (Dibble, et al., 2003).
Currently, patients’ anxiety and ANV can only be improved by reassurance from
nurses, pharmacological use and referring symptomatic cases to a clinical
psychologist. However, time available for nurse counseling is limited due to a
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shortage of manpower. Moreover, the choice of anxiolytic and anti-emetic drugs are
limited and not recommended since their side effects may induce drowsiness, further
worsening the patients’ fatigue and concentration (Traeger, et al., 2012). On the other
hand, the clinical psychologist will only be referred in the target clinic if the cancer
patient experiences excessive anxiety causing a psychological disorder. The waiting
period for such a consultation is often more than two weeks once a referral is
recommended.
A local survey (Williams, et al., 2010) reported that massage becomes a useful
means for cancer patients in dealing with such physically and psychologically
stressful treatments for enhancing their quality of life. However, massage is not a
routine CAM being integrated into cancer treatment in Hong Kong, including the
target center. Discussions about massage therapy between cancer patients and health
care professions are also uncommon in the target center. To date, no study has been
conducted in Hong Kong on the effectiveness of massage therapy in reducing anxiety
on cancer patients undergoing chemotherapy. Therefore, a literature review must be
performed to examine the effectiveness of massage therapy for cancer patients
receiving chemotherapy in relieving anxiety and thus reducing the severity of ANV.
1.3 Objectives and significance
The burden of psychological distress, anxiety and depression in cancer
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patients undergoing chemotherapy cannot be neglected. Ineffective coping of anxiety
may cause anxiety disorders and depression, which has been estimated to be 4 times
more common in cancer patients compared to the general population (Corbin, 2005).
Anxiety may also exacerbate cancer patients’ physical symptoms such as nausea,
vomiting, insomnia, fatigue and decreased appetite, which will further impair their
quality of life (Corbin, 2005). Massage therapy is believed to help cancer patients to
interrupt the cycle of distress and induce a relaxation response, thus, improving their
quality of life (Ahles, et al., 1999). It is also believed to have a boosting effect on the
immune system and an increase in serotonin level which reduces muscle tension and
anxiety (Billhult, et al., 2007).
Current oncology treatment has evolved from merely cancer killing to enhancing
patients’ comfort throughout their treatment and recovery phases (Currin & Meister,
et al., 2008). There is a growing need in CAM to augment cancer care. However,
discussion on the use of massage between nurses and cancer patients remains
uncommon in most clinical settings (Ahn, et al., 2006). Health care professionals are
an important and trustful source of information on medical treatment for cancer
patients (Li, et al., 2010). With the increasing use of massage therapy within the
community, nurses have an obligation to provide information and service for cancer
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patients to reduce their anxiety and mood disturbance, assisting them in going through
the treatment period.
Therefore, the research question is posed; ‘Is massage therapy effective in
reducing anxiety in adult cancer patients undergoing chemotherapy?’
The objectives of this dissertation are as follows:
1. To review studies on the effectiveness of massage in reducing anxiety of adult
cancer patients undergoing chemotherapy.
2. To critically appraise, summarize and synthesize the research findings from
selected studies.
3. To formulate evidence-based guideline on implementing massage therapy for
cancer patients undergoing chemotherapy.
4. To assess the implementation potential of the proposed massage program.
5. To develop an implementation and evaluation plan for the proposed program.
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Chapter 2: Critical Appraisal
In this chapter, a literature review is performed with the detailed search strategies
described. Then, a critical appraisal is done on the selected studies, and
recommendations are made after summarizing and synthesizing the data extracted
from those studies.
2.1 Search strategies
Both electronic and manual searches were performed from 29th
July 2012 to 30th
August 2012 to identify eligible studies for a comprehensive literature review. Five
electronic databases: Medline (OvidSP) (1946 to July Week 3 2012), CINAHL Plus
(EBSCOHost) (1967 to 2012), British Nursing Index (ProQuest), The Cochrane
library and The PsycINFO (1800s to 2012), were used.
Several keywords were used to limit the number of literature results related to
the chosen topic. The keywords used were grouped according to population (Cancer,
neoplasm, oncology, carcinoma, malignancy), treatment (chemotherapy), intervention
(massage therapy, complementary treatment, alternative therapies and alternative
medicine), and outcome (anxiety, anxiety disorder, mood disturbance, psychological
discomfort, relaxation, anticipatory nausea and anticipatory vomiting).
2.1.1 Selection criteria
Inclusion and exclusion criteria were developed to select eligible studies. For
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the inclusion criteria, studies must be randomized controlled trials (RCTs). RCTs
have the highest level of evidence to examine the effectiveness of the studied
intervention (Petrisor & Bhandari, 2007). Studies should be written in English since
the author is unable to translate the studies appropriately and precisely into English.
The participants of the studies should be cancer patients aged 18 or above, as the
target population is adult cancer patients. Moreover, massage therapy should be the
only intervention assigned to the intervention group. Any combinations of massage
with other innovations such as aromatherapy or reflexology as the only intervention
were not included to avoid any confounding effect. Also, the included studies had to
have at least one outcome measure relating to anxiety. Any unrelated massage such as
prostatic massage and carotid massage were also excluded.
2.2 Search results
Details of the search history and a summary of the search results are shown in
appendix A and B respectively. After manual screening using the inclusion and
exclusion criteria and discarding duplicated ones, nine studies were identified. A
manual search from the reference list was also performed and no further studies were
found. A list of the selected papers is shown in appendix C.
2.2.1 Study characteristics
All of the nine selected papers were published from 1999 to 2011. The
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majority of these were conducted in western countries: three in the USA (Ahles, et al.,
1999; Hernandez, et al., 2004; Post-White, et al., 2003), two in the UK (Soden, et al.,
2004; Sharp, et al., 2010), one in Germany (Listing, et al., 2010), two in Sweden
(Billhult, et al., 2007; Billhult, et al., 2008) and one in Taiwan (Jane, et al., 2011).
Massage therapy was the only different treatment used between the
intervention and control groups in all studies. Participants of both the intervention and
control groups within each study (N=9) were given the service in the same
environment such as a quiet and private room to minimize any confounding factors
altering the study’s outcomes.
2.2.2 Methodological assessment
The quality of the studies was evaluated by the Critical Appraisal Skills
Programme (Guyatt, Sackett, & Cook, 1993, 1994). Its RCTs checklist, which
consists of 10 questions, was used as the appraisal tool to guide the review. Detail of
the RCTs checklist is shown in appendix D. Then, the level of evidence for all
selected studies was classified using the Scottish Intercollegiate Guidelines Network
(SIGN) (SIGN, 2008). Details are provided in appendix E.
All studies stated clearly-focused research questions including the population
(cancer patients), intervention (massage therapy) and the outcomes related to anxiety.
All studies are RCTs which was considered to have the most powerful and convincing
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evidence on the causal effect between interventions and study outcomes (Petrisor &
Bhandari, 2007).
All participants in the nine studies were appropriately allocated to either
intervention groups or control groups by randomization. Seven studies clearly stated
their method used for randomization. Four studies were using sealed opaque
envelopes (Soden, et al., 2004; Bullhult, et al., 2007; Billhult, et al., 2008; Sharp, et
al., 2010); one study used a computer program (Jane, et al., 2011); one study used a
simple randomization list (Listing, et al., 2010) and one study used the flip of a coin
(Hernandez-Reif, et al., 2004). All studies compared baseline demographic variables
between intervention and control groups at the entry of the trials. Only one study
showed significantly more women in the control group than the intervention group
after randomization (Soden, et al., 2004). Nevertheless, their baseline assessment
scores of the measured outcomes were compared and showed no significant
difference between groups.
It was not feasible to ‘blind’ participants for the group assignments. They
would know whether they were in the control group receiving usual care, or the
intervention group receiving massage therapy. However, an informed consent was
obtained from the participants prior to the treatment allocation. Concealment was
achieved. Three studies had enough participants to have a statistical power of 80%
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(Hernandez-Reif, et al., 2004; Post-White, et al., 2003; Billhult, et al., 2008), and two
studies had enough participants to reach the power of 95% (Sharp, et al., 2010; Jane,
et al., 2011). However, one study’s sample size was less than expected (Soden, et al.,
2004), and three studies did not set minimum sample size to achieve certain statistical
power (Ahles, et al., 1999; Listing, et al., 2010; Bullhult, et al., 2007). Those with
insufficient sample size might cause difficulties in establishing a conclusion as to
whether the outcome was a real effect from massage therapy or due to some
characteristic of the participants, causing a risk for inducing type II errors (Soden, et
al., 2004).
All nine studies used self-assessment tools for primary outcome data
collection. Some studies (N=5) used one-dimensional tools such as State Trait
Anxiety Inventory (STAI), visual analogue scale (VAS) on relaxation, mood and
nausea (Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Billhult, et al., 2007;
Billhult, et al., 2008; Jane, et al., 2011). The reliability and validity of these tools are
well established (Spieberger, 1983; Lee & Kieckhefer, 1989). A two-dimensional
tool, the Hospital Anxiety and Depression Scale (HADS) was also used to measure
the change in anxiety and depression level for the participants (Soden, et al., 2004;
Sharp, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Its validity was also
verified (Zigmond & Snaith, 1983). Furthermore, some multi-dimensional tools, the
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Profile of Mood States (POMS), the Mood Rating Scales (MRS) and the Berlin Mood
Questionnaire (BMQ) had been used to measure participants’ mood states and quality
of life in 3 studies (Post-White, et al., 2003; Listing, et al., 2010; Sharp, et al., 2010).
These tools consist of several subscales measuring participants’ anxiety level and
their reliability was also well established (Redd, et al., 1991; Anderson, et al., 2000;
Hoerhold & Klapp, 1993). All of the assessment tools used were self reported
questionnaires to measure subjective feelings of anxiety. Therefore, the data can be
collected without using an interviewer or data collector to decrease the risk of
detection bias (Gurusamy, et al., 2009).
All nine studies present their results precisely using mean change, percentage
change and effect size of the scores by different well established measuring tools. All
studies set 5% as the level of significance. Six studies showed the baseline scores and
change in post intervention scores in the form of tables, while the other three studies
(Post-White, et al., 2003; Listing, et al., 2010; Jane, et al., 2011) presented the results
in the form of both tables and graphs of mean score over time. All tables and graphs
were clearly presented with the p-value provided so that the effect of massage therapy
at different time periods was clearly indicated.
According to the above critical appraisal, three studies (Sharp, et al., 2010;
Hernandez-Rief, et al., 2004; Jane, et al., 2011) were graded as the highest quality
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RCTs with a very low risk of bias (1++) while four studies (Ahles, et al., 1999;
Post-White, et al., 2003; Listing, et al., 2010; Billhult, et al., 2007) were rated 1+ with
a low risk of bias. The remaining two studies (Soden, et al., 2004; Billhult, et al.,
2008) were labeled as high risk of bias (1- ). A detailed quality assessment of each
selected study is shown in appendix F.
2.3 Summary and synthesis of data
The contents of the selected studies were reviewed and data were extracted
using tables of evidence. The tables of evidence for each study are itemized in
appendix G and the summary is briefly described. Appendix H clearly shows a table
of summary for the studies’ results.
2.3.1 Characteristics of participants
All participants in the nine studies were cancer patients and five of them were
breast cancer female patients (Sharp, et al., 2010; Hernandez-Reif, et al., 2004;
Listing, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Also, participants in
five studies were receiving chemotherapy during the study period (Ahles, et al., 1999;
Sharp, et al., 2010; Post-White, et al., 2003; Billhult, et al., 2007; Jane, et al., 2011).
This population is the same as that in the local setting, a chemotherapy day ward,
where breast cancer patients are the majority in the population. These patients require
a relatively longer treatment period, about one and a half years to receive target and
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conventional chemotherapy. In addition, women with breast cancer are a vulnerable
group among cancer patients since they are at higher risk for depression, elevated
stress and anxiety levels, and anger (Longman, et al., 1999).
The mean age of participants ranged from 41 to 62.5 in eight studies except
one study with a median age of 73 (Soden, et al., 2004). This is similar to the peak age
group among the prevalence of cancer in Hong Kong, aged 45-64 (Hong Kong Cancer
Registry, 2009). Therefore, the results of the studies should be applicable to the local
clinical setting.
2.3.2 Selection of participants
Although no adverse effect was reported in all the selected studies, some
literature showed that massage might increase the risk of fractures and dislocation,
hemorrhage, hematoma and dislodging of deep vein thrombosis in certain populations
(Corbin, 2005). Participants in all the studies required doctor approval before entering
the studies. In addition, assessment had been done in some studies to exclude cases
with underlying medical conditions such as lymphoedema, inflamed skin in the area
of therapy, anticoagulants problems, thrombocytopenia, spinal cord compression
syndrome and deep vein thrombosis (Hernandez-Reif, et al., 2004; Listing, et al.,
2010; Jane, et al., 2011). Moreover, Post-White, et al. (2010) stated that the massage
technique and the area of massage should be modified and adjusted to avoid tumor or
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surgical sites. The study also suggested that the depth of touch should be limited
according to individual tolerance (Post-White, et al., 2010). Therefore, assessment
should be performed prior to the proposed massage therapy. Furthermore, an
informed consent should be obtained from participants prior to massage therapy to
ensure that participants understand the purpose of the program and the risk of the
intervention, even though the adverse effect of massage therapy reported to be very
low in all the studies.
2.3.3 Dropout rate
The dropout rate among the selected studies ranged from 0-29%. Eight studies
had a dropout rate less than 20%. Some studies tried to minimize the possibility of
dropout by offering the control group to receive complimentary massages
(Hernandez-Rief, et al., 2004; Jane, et al., 2011) and progressive muscle relaxation
(Listing, et al., 2010) after completion of the studies. Eventually their dropout rates
were lowered to 0% (Hernandez-Rief, et al., 2004), 6.9% (Jane, et al., 2011) and
14.7% (Listing, et al., 2010). One study (Post-White, et al., 2003) had a dropout rate
of 29% and it explained that the participants left the study due to their advancing
disease causing a subsequent change in their treatment plan or the participants died
before completion of the study. Nevertheless, no differences had been detected from
the baseline data between adherers and dropouts in the study.
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In addition, all dropout participants in all the studies were included to which
they were originally allocated for intention-to-treat analysis so that all participants
were accounted for at the conclusion to ensure the validity of the results (Montori &
Guyatt, 2001).
2.3.4 Intervention
The overall effectiveness of massage therapy in reducing anxiety for cancer
patients has been demonstrated among the selected studies. After implementing
massage therapy for cancer patients, two of them found that the mean STAI-S scores
have been significantly decreased by >10 (P<0.05) (Ahles, et al., 1999;
Hernandez-Reif, et al., 2004). One study had significant decrease in median HAD
scores by 2 after massage therapy (P≦0.05) (Soden, et al., 2004). Sharp, et al. (2010)
also found that the mean difference of MRS relaxation subscale had significantly
reduced by ≧18 (P≦0.02). Post-White,et al. (2003) showed that the mean difference
of POMS mood disturbance and anxiety subscales had improved by ≧3 significantly
(P≦0.02). In addition, Listing, et al.’s study (2010) calculated the effect size of
BMQ-anxious depression as 0.9 (P<0.05) in the study while Jane, et al.’s study (2011)
got a significant improvement in VAS- relaxation in their study with effect size ≧
0.45 (P≦0.03). Only 2 studies failed to prove the effect of massage in reducing
anxiety (Billhult, et al., 2007; Billhult, et al., 2008). However, the mean change of
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VAS nausea in Billhult, et al. study (2007) had significantly improved (P=0.025).
Although the STAI-S score in Billhult, et al.’s study (2008) was not significantly
improved, this score from their intervention group had still been greatly reduced.
Small sample size was the major cause for these diverse results, recruiting only 19
(Billhult, et al., 2007) and 11 (Billhult, et al., 2008) participants into each treatment
group in their studies. Small sample size might alter the results caused by
confounding factors such as age and disease prognosis of the participants other than
the effect of the interventions (Gurusamy, et al., 2009). Nevertheless, none of the
studies showed any negative effect of massage therapy on cancer patients.
2.3.5 Type and area of massage used
Majority of the studies (N= 7) used the Swedish technique to implement
massage therapy and five of them showed significant effect in anxiety reduction
(Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Post-White, et al., 2003; Listing, et
al., 2010; Jane, et al., 2011). Swedish massage is the technique of using smooth, long,
rhythmical strokes and gentle kneading of the body. This type of massage is soft and
comfortable enough for cancer patients (Billhult, et al., 2007).
Five studies applied massage over the participants’ whole body and upper part
of body which showed an effective improvement in anxiety level (Hernandez-Reif, et
al., 2004; Ahles, et al., 1999; Post-White, et al., 2003; Listing, et al., 2010; Jane, et al.,
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2011). However, only one study was conducted in a Chinese country, Taiwan (Jane,
et al., 2011).
2.3.6 Duration and frequency of massage
Majority of the studies (N=6) set the duration of the massage therapy as 20-30
minutes (Soden, et al., 2004; Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Listing,
et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Three of the studies (Ahles, et
al., 1999; Hernandez-Reif, et al., 2004; Listing, et al., 2010) showed significant
improvement in anxiety and one of them showed a reduction in the sense of nausea
(Billhult, et al., 2007).
The frequency of massage sessions among the studies was discrete. Some
studies performed massages weekly over 4 to 8 weeks (Soden, et al., 2004; Sharp, et
al., 2010; Post-White, et al., 2003) while some studies performed massages two to
three times weekly over 3 to 5 weeks (Ahles, et al., 1999; Hernandez-Reif, et al.,
2004; Listing, et al., 2010; Billhult, et al., 2008). One study implemented massage
therapy concurrently with chemotherapy for 5 cycles (Billhult, et al., 2007); and one
study performed massage on 3 consecutive days (Jane, et al., 2011).
2.4 Recommendation and conclusion
After summarizing and synthesizing the data from the selected studies, it can
be concluded that massage therapy is proven to be effective in relieving anxiety in
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cancer patients. As such, it is proposed to implement a massage program in the target
chemotherapy day ward to reduce anxiety in cancer patients receiving chemotherapy.
Swedish massage will be used in the proposed massage program.
Traditionally, Chinese people are less physically expressive than people in
western countries. They might feel as though they are being violated by others due to
excessive physical contact. The studies of Billhult, et al. (2007) and Billhult, et al.
(2008) also stated that participants preferred to receive massage on their foot and
lower leg rather than hand and lower arm if choice was provided. Moreover, patients
in the target center will receive chemotherapy via peripheral vein over their hands and
lower arms. Therefore, foot and lower leg massage is preferred to avoid cancer
patients requiring frequent change in position or feeling uncomfortable with intimate
touch during massage.
20-30 minutes is seen as suitable for the target population since the
administration duration of chemotherapy is 30 minutes. Setting the duration of
massage therapy as 20-30 minutes can minimize a prolonged stay in the day ward for
the target participants. In addition, frequent hospital visits may cause fatigue for
participants and thus affect the outcomes and dropout rate of a massage program.
Therefore, the frequency of massage proposed for the target chemotherapy day ward
will be concurrent with participants’ chemotherapy regimen, which is one session
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every 3 weeks.
Although all of the studies used self reported questionnaires to measure the
subjective feeling of anxiety for cancer patients, the measuring tools used amongst the
studies varied. Anxiety possesses a multi-dimensional effect that correlates and
affects a person’s mood and quality of life, however, a one-dimensional measuring
tool is preferred to provide a simple, reliable and direct measure for the proposed
innovation (Seligman, et al., 2001). The STAI consists of two 20-items instrument
with a four point Likert Scale to measure current anxiety level (state anxiety), and the
tendency to experience anxiety (trait anxiety) (Spielberger, 1983). The higher score in
STAI indicates the high level of anxiety. The STAI-state portion (STAI-S) is
recommended to measure the current change in anxiety level before and after the
proposed massage therapy. Its reliability and validity have been well proven and the
internal consistency alpha coefficients of the state portion ranged from 0.82 to 0.92
(Spieberger, 1983). In addition, the Chinese version of the STAI-S, as shown in
appendix N, is readily available and its reliability and validity has been well
established (Shek, 1993). Thus, it will be used for the proposed massage program as
the target participants are all Chinese. A detailed evaluation plan will be elaborated in
chapter 4.
In conclusion, it is proposed to implement a massage program, providing a
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30-minute Swedish massage on foot and lower legs for cancer patients undergoing
each cycle of chemotherapy in a local chemotherapy day ward to relieve their anxiety
and ANV so as to improve their quality of life.
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Chapter 3: Translation and Application
The literature review in previous chapters showed that massage therapy is
effective in reducing anxiety for cancer patients receiving chemotherapy. The
implementation potential of this innovation should be examined before it can be
translated and applied to the target local setting (Polit & Beck, 2008).
In this chapter, the transferability and the feasibility of the massage innovation
are examined. The potential risks, benefits and the cost of the proposed program are
analyzed to determine the worthiness of implementation in the target setting.
3.1 Implementation potential
3.1.1 Transferability of the findings
3.1.1.1 Target setting
Massage therapy is proposed to be implemented in a chemotherapy day ward
which is an out-patient setting managed under the Clinical Oncology Department of a
public hospital. Cancer patients must be seen and reviewed by oncologists during
each follow-up to ensure their suitability for each cycle of chemotherapy. Cancer
patients will then be admitted to the day ward on the same day or the day after the
follow-up, if they are suitable for chemotherapy.
The target setting consists of twenty-eight chemotherapy chairs. The proposed
innovation will be implemented on those chairs since massage can be applied to the
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cancer patient in a seated position, as was the case in three reviewed studies (Billhult,
et al., 2007; Billhult, et al., 2008; Sharp, et al., 2010).
There are six nurses responsible for chemotherapy administration in the
chemotherapy day ward. Due to their heavy workload, it might not be feasible for
them to perform the massage in the proposed program. The cancer patient resource
centre of the target hospital will allocate a total of 25 volunteers. Five volunteers will
stay in the day ward each day to provide counseling for the cancer patients. These
volunteers are also cancer patients who have completely recovered. They are well
trained and qualified with more than 3 years experience on communicating and taking
care of cancer patients. Some of the reviewed studies (Ahles, et al., 1999; Billhult, et
al., 2007; Hernandez-Reif, et al., 2004) recruited self-trained nurse’s aides to perform
massages, resulting in promising outcomes. Therefore, the proposed program will
train volunteers to perform the massage to cancer patients who are waiting for their
chemotherapy in the day ward, under nurses’ supervision.
3.1.1.2 Target audience
Patients from both the reviewed studies and the target setting are cancer patients
including hematology malignancy and solid tumor with or without metastasis.
According to the annual statistics in the target setting, there were 11,692 cancer
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patients admitted to the target setting with the mean age of 58 last year. This is similar
to those from the reviewed studies that the mean age ranged from 41 to 62.5 years old.
One reviewed study (Jane, et al., 2011) was conducted in Taiwan in which all
participants were Chinese with 76% believed in Buddhism or Taoism. This is also
comparable to the target patients as the majority of them are Chinese and also believe
in Buddhism or Taoism. A descriptive study (Williams, et al., 2010) reported that
massage is one of the complimentary methods for adult cancer patients in Hong Kong
to relieve discomfort caused by chemotherapy. In addition, four reviewed studies
involved participants that were currently receiving chemotherapy (Ahles, et al., 1999;
Billhult, et al., 2007; Jane, et al., 2011; Post-White, et al., 2003). Therefore, the target
patients in the proposed setting have similar characteristics as the patients in the
reviewed studies.
3.1.1.3 Philosophy of care
As the core value of the Hospital Authority is to provide ‘client-centered care’,
healthcare professionals should not only give patients life-saving treatment but also
empower them to regain their health, optimizing their quality of life. Cancer patients
are not merely facing physical distress but they also experience psychological distress
such as anxiety during their chemotherapy treatment (Ahles, et al., 1999; Bullhult, et
al., 2008).
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The massage innovation falls within this prevailing philosophy of care. As
cancer patients are seeking alternative ways to improve their quality of life, oncology
nurses have an obligation to ensure cancer patient’s quality of life in their cancer
trajectory. Therefore, both reviewed studies and the target hospital share the same
philosophy of care.
3.1.1.4 Proposed massage intervention
Six reviewed studies used 20 minute to 45 minute Swedish massage showing
significant improvement in reducing cancer patient’s anxiety (Ahles, et al., 1999;
Billhult, et al., 2007; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al.,
2010; Post-White, et al., 2003). They believed that Swedish massage with its light
strokes and kneading technique is soft and gentle enough for cancer patients.
Therefore, Swedish massage will be used as the massage technique in the proposed
program.
The waiting time for cancer patients to start chemotherapy infusion after
admission is about 30 minutes to 1 hour in the day ward. Therefore, the duration of
the proposed massage is to be 30 minutes before chemotherapy infusion, to avoid
prolonging the patient’s length of stay.
In the target setting, the total sessions for a majority of chemotherapy treatments
are 4 to 6 sessions. As massage therapy will be given to cancer patients during their
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second chemotherapy session, a maximum of 5 sessions will be given to each eligible
cancer patient or until their chemotherapy treatment is completed.
The preparation, implementation and evaluation of the proposed innovation will
last for one year. A pilot study will be conducted to assess the feasibility and examine
any difficulties encountered during implementing the program. Details of the pilot
study will be discussed in chapter 4.
3.1.2 Feasibility of the innovation
3.1.2.1 Organizational and administrative support
The administrators of the Clinical Oncology Department include the Chief of
Service (Clinical Oncology), Consultant, Clinical Oncologists, Department Operation
Manager of Clinical Oncology, Nurse Consultant, Ward Manager and the Project
Manager of the cancer patient resource center who supervises the volunteers. The
atmosphere of promoting evidence-based practice in the department is positive. The
Nurse Consultant and the Ward Manager always offer opportunities for staff to attend
conferences to update their professional knowledge. They share the latest research
findings with colleagues and develop evidence-based guidelines for clinical use. As
the target hospital is a teaching hospital of a university in Hong Kong, the
stakeholders are well aware of the importance of evidence-based practices to improve
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cancer treatment and service for patients. It is foreseeable that such a supporting and
experienced team will give positive support for implementing the proposed program.
3.1.2.2 Frontline staff support
There are a total of 15 nurses, including an advanced practice nurse, registered
nurses and enrolled nurses, being rotated in the outpatient clinics within the
department. These frontline staff have already noted that anxiety is one of the most
common reactions among patients undergoing chemotherapy. They report spending
most of their time reassuring and persuading anxious patients to receive
chemotherapy after their admission. The proposed massage program can reduce
anxiety and thus comfort anxious patients. This will then shorten nurses’ time spent
with the symptomatic patients.
In addition, nurses in the target setting are experienced in implementing
evidence-based practices. They understand and even welcome using new
evidence-based practices and its benefits for patients. The APN of the target setting
also pays due attention to implementing evidence-based practices. She continually
arranges lessons for nurses to update their clinical knowledge and practices related to
oncology care based on literature evidences. For example, she has illustrated the best
practice of central venous catheter care in order to reduce risk of infection last year.
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All frontline nurses demonstrate supportive attitudes to change of current practices
whenever there is a need.
However, there are two possible factors that may undermine efforts to implement
the proposed massage program. Firstly, nurses need to spend time to attend training
sessions for the massage program during their working hours. It may increase the
workload of the other nurses who remain in the clinic during the training session.
Secondly, the change in current practice may cause stress to nurses because of the
unfamiliar guidelines and workflow of the massage program.
In order to avoid disturbing the daily operation of the out-patient clinics and
chemotherapy day ward during the training sessions, two identical two-hour training
sessions will be held in the conference room of the department. All nurses and the
volunteers recruited will be invited to attend one of the training sessions. Also, the
training sessions will be held on Friday from 3:30 pm to 5:30pm when it is less busy
in all clinics and chemotherapy day ward. The Advanced Practice Nurse, experienced
in performing massage to cancer patients, and the programme coordinator will be
responsible for the trainings. Patient benefits, program logistics, nursing assessment,
evaluation method of the innovation and the massage guideline will all be introduced
in the training programme. In order to minimize nurses’ workload, it will be explained
that they are only required to perform the assessment, using a self-designed
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assessment form, and supervise the volunteers who perform the massage. Details of
the training sessions will be explained in Chapter 4.
Furthermore, a working group including 1 advanced practice nurse and 6 senior
registered nurses (RNs) will be established to organize, implement and evaluate the
massage program. The working group will supervise nurses and the trained volunteers,
and monitor the progress of the massage program. All nurses will be welcome to
consult the working group if they have any query during the implementation period to
minimize their stress due to this unfamiliar massage program.
3.1.2.3 Volunteers’ support
Massagists for the proposed program will be chosen from the volunteer staff at
the Patient Resource Center. The goal of the center is to ensure the best-possible
service towards optimizing cancer patients’ quality of life. The center’s manager and
the volunteers are supportive of utilizing evidence-based practices in their services. It
is their common practices to organize evidence-based workshops such as peer support
groups and role playing for cancer patients. This is intended to provide psychological
support and to strengthen their self care ability. They are also familiar with
introducing some complimentary methods, with evidence support, to cancer patients
in order to relieve physical discomfort.
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One element of concern stems from the fact that these volunteers are all cancer
patients who have completely recovered. Acting as the massagists in this program
may become physically demanding to the volunteers. Therefore, discussions will be
held with the project manager to invite eligible volunteers to join the massage
program. Ten volunteers will be recruited and trained. During the implementation
period, volunteers will only need to perform not more than 2 massages each day to
prevent overwhelming them. A detailed implementation plan will be described in
Chapter 4.
A further source of potential stress for volunteers may result from being
unfamiliar with the massage technique. Therefore, it will be guaranteed that training
will be given before implementing the program and that nurses will supervise them
during the massage intervention. Furthermore, regular meetings with nurses and
volunteers will be conducted for sharing opinions and raising concerns so that any
difficulties can be tackled in advance.
3.1.3 Cost/Benefit ratio of the program
3.1.3.1 Potential risks
All nine reviewed studies claimed that massage therapy is a safe treatment with
no adverse effects reported. Moreover, there is no evidence that massage therapy can
spread cancer from its local region to distal body area (Corbin, 2005). Swedish
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massage is relatively safe when compared to other vigorous massages such as deep
body massage which might cause fracture, haematoma and pulmonary embolism
(Ernst, 2003). Even though complications related to Swedish massage is rare, the
possibility of developing bruising, hematoma and pain cannot be ignored (Corbin,
2005). Therefore, training for identifying and managing possible complications
should be given to nurses. Nursing assessment is also essential to exclude cancer
patients with contraindication such as coagulation disorder and deep vein thrombosis
from participating in the program (Billhult, et al., 2007; Post-White, et al., 2003). The
evidence-based guideline for massages will act as a reference for implementing the
program. Trained volunteers are also required to report to the core members promptly
when patients have any discomfort during massage.
Medical involvement in excluding high risk patients from the program is
essential to minimize risks for cancer patients receiving massage. The Oncologist’s
approval for patients to receive massage therapy should be obtained during the
patient’s follow-up for the second cycle of chemotherapy. Medical support from
oncologists is also required for managing any massage-related complications during
the implementation period. Therefore, a meeting will be arranged with all oncologists
in the department to introduce this program to them. Seeking their support is
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necessary for identifying eligible patients for this program and managing patients with
massage-related complications, should these occur.
3.1.3.2 Potential benefits
As previously stated, massage therapy can greatly improve both physical and
psychological distress (Corbin, 2005). A nonrandomized study (Grealish, et al., 2000)
reported that even a 10 minute leg massage immediately improved pain, nausea and
anxiety in cancer patients. Physiologically, Field (1998) found that massage can
trigger the release of some hormones and neurotransmitters, leading to improvement
in mood, severity of nausea and sleeping quality. With improvement in these physical
symptoms, and hence quality of life, cancer patients are likely to complete
chemotherapy treatment as planned without delaying or terminating unnecessarily
(Corbin, 2005).
There is an increase in cancer patients seeking information about massage
therapy to relieve treatment-related discomfort. Implementing this program would
enrich nurse’s professional knowledge about massage and by doing so nurses can
provide a means for cancer patients to consider the information. With the target
setting being able to provide a qualified massage service for cancer patients, this will
enhance both holistic patient care and nurses’ job satisfaction.
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As massage therapy can be performed by nurses, volunteers and family members
(Reaves & McManis, 2010). If this program can be proved as effective in reducing
anxiety, nurses can teach patient’s families to perform massage for cancer patients
themselves. Consequently, cancer patients can receive massages at home more
frequently and therefore, better control the patient’s discomfort. Rapport between
nurses, patients and their family members can also be enhanced from this interaction.
Although implementing the program may induce extra workload for nurses, their
effort in managing patients with anticipatory nausea and vomiting will then be
inversely lower if patient’s anxiety level is reduced by the massage program.
From observation, there are approximately half of the cancer patients admitted to
the day ward behave anxiously. Considering 20% of these patients are eligible and
willing to participate in this program, it is estimated that there will be 1,169 cancer
patients benefiting from this program every year.
3.1.3.3 Cost
Without effective intervention, cancer patients experiencing severe nausea and
vomiting due to chemotherapy may suffer from dehydration or electrolyte imbalance.
It may lead to not only delaying their chemotherapy treatment but also being admitted
to the day ward or even to the in-patient unit for rehydration or electrolyte supplement.
This causes extra admission and medical treatments for the patients during their
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treatment period, increasing medical expenses for cancer patients. As cancer patients
are required to pay an additional $150 for every extra admission, this may increase the
patients’ financial burden, on top of their current medical costs.
During patients’ follow-up, if they feel nervous about chemotherapy or their
nausea and vomiting was poorly controlled in the previous admission, doctors may
add a potent anti-emetic, i.e. the 5-HT3-receptor antagonist on top of the usual
anti-emetics. Yet, these strong anti-emetics such as Navoban are relatively expensive
($63.5/tablet) when compared with the commonly used anti-emetics such as Maxolon,
($0.08/tablet). These potent anti-emetics also carry more side effects. If implementing
the massage program reduces patient’s anxiety and decreases their severity of nausea
and vomiting, then the use of such costly anti-emetics will be lowered. If the use of
those potent anti-emetics can even be reduced by 20% among the patients in the
massage program, the medication expense can be greatly reduced. The estimated
expense that can be saved is calculated in appendix I. It is estimated that $57,000 will
be saved on the use of potent anti-emetics after cancer patients join the massage
program.
On the other hand, implementing the massage program will bear some material
costs. However, these costs will be limited to stationery and massage oil since
audio-visual aids and the conference venue are already available at the target setting.
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Assuming that there will be 1,100 cancer patients joining the massage program a year,
the estimated annual budget for running the program will be $12,000. A detailed
budget plan is listed in Appendix J.
The necessary training and preparation for this massage program will require
extra expenditures from the department. However, considering the patient benefits
and the long term cost saved from using costly anti-emetics, it is worth to implement
the massage program in the target setting.
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Chapter 4: Evidence-Based Practice Guideline
The evidence-based practice (EBP) guideline is developed based on the literature
review conducted in the previous chapter. It provides structural and clear information
for nurses on the use of massage on adult cancer patients receiving chemotherapy to
reduce anxiety in the target hospital. The level of evidence and recommendations
extracted from the nine RCTs are graded according to the Scottish Intercollegiate
Guideline Network (SIGN, 2008), as shown in appendix E and K respectively. A
working group will be formed to include Clinical Oncologists, the Nurse Consultant
and the Ward Manager to develop and review the guideline regularly to ensure its
quality and applicability. The aim, objectives, target population and recommendations
are extracted and shown below. A detailed EBP guideline is available in appendix L.
4.1 Aim
The aim of this guideline is to implement feasible and effective massage
interventions to reduce anxiety for cancer patients receiving chemotherapy in an
outpatient clinic setting.
4.2 Objectives
To provide a consistent framework for implementation of safe and effective massage
therapy to cancer patients to reduce their anxiety from receiving chemotherapy.
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4.3 Target population
The massage therapy is applicable to both male and female adult cancer patients
who are receiving chemotherapy in the chemotherapy day ward.
Inclusive criteria
- Aged 18 or above
- Cantonese- and Mandarin-speaking patients who are able to read Chinese.
- Cognitively competent
Exclusive criteria
- Coagulation disorder
- Spinal cord injury
- Venous thrombosis
- Bone metastasis
- Peripheral neuropathy
- Radiation dermatitis
- Open wound over lower limbs
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4.4 Recommendations
Recommendation 1.0
Nursing assessment should be performed to exclude high risk patients from
joining the massage program. (Grade of recommendation: A)
Patients with medical conditions including coagulation disorder, spinal cord
injury, thrombosis, bone metastasis, peripheral neuropathy, radiation dermatitis and
open wound over lower limbs are excluded from receiving massage in four of the
reviewed RCTs(Hernandez-Reif, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010;
Listing, et al., 2010). This is necessary as these conditions may heighten the risk of
massage complications such as neuropathy damage, hematoma, bleeding and
dislodging of deep venous thrombosis causing embolism (Hernandez-Reif, et al,
2004; Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010) (1++; 1++; 1++;
1+).
Recommendation 2.0
Swedish massage is recommended to perform on patient’s lower limbs.
(Grade of recommendation: A)
No complication such as fractures, dislocations, nerve damage and pulmonary
embolism were reported from participants in seven reviewed RCTs which used
Swedish massage as their intervention. (Ahles, et al., 1999; Billhult, et al., 2007;
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Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al.,
2010; Post-White, et al., 2003). (1+; 1+; 1-; 1++; 1++; 1+; 1+)
Recommendation 3.0
The duration of massage therapy is recommended as 30 minutes. (Grade of
recommendation: A)
Six reviewed studies used 20-30 minute massage and five of them reported to
have positive effects in reducing level of anxiety and sense of nausea for cancer
patients (Ahles, et al., Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif,
et al., 2004; Listing, et al., 2010; Soden, et al., 2004). The immediate short-term (30
min) benefits of massage therapy is well proved to reduce anxiety for cancer
patients (Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden et al., 2004).
(1++; 1+; 1- )
Recommendation 4.0
The State-Trait Anxiety Inventory (STAI-S) measuring tool should be used to
measure the patient’s level of anxiety before and after the massage so as to
evaluate the effectiveness of this massage program. (Grade of
recommendation: A)
Five reviewed RCTs used one-dimensional self assessment tools to measure the
subjective feeling of anxiety for cancer patients (Ahles, et al., 1999; Billhult, et al.,
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2007; Bullhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011). Three
of them used STAI-S assessment tool to measure anxiety level for cancer patients
and resulted in decrease in their anxiety level (Ahles, et al., 1999; Billhult, et al.,
2008; Hernandez-Reif, et al., 2004). STAI-S is a valid and reliable
one-dimensional assessment tool that is short and easy for cancer patients to
complete. (1+; 1-; 1++)
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Chapter 5: Implementation Plan
An implementation plan is essential to facilitate communication and the
realization of the massage innovation into the target setting. This chapter will
illustrate a detailed communication, execution and evaluation plan for the massage
program for cancer patients receiving chemotherapy in the target setting.
5.1 Communication plan
Communication enhances dissemination of information about the
innovation among the stakeholders who are the key persons affecting the success of
the program (Burns and Grove, 2005). A good communication plan is needed in order
to give stakeholders a better understanding of and support for the innovation. The
stakeholders of this program would include the hospital administrators, frontline
nurses, cancer patients, and volunteers and the manager from the patient resource
centre.
5.1.1 Identifying stakeholders
The Chief of Service (Clinical Oncology), the Department Operation Manager
(DOM), the Nurse Consultant and the Ward Manager are the key administrators. They
have the authority to endorse guidelines and interventions used in the target setting.
Their approval must be obtained before implementing this massage program.
Therefore, the aims, benefits and costs of this program will be explained to them
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through meetings and emails to gain their support. In addition, they will be consulted
for opinions to revise the guidelines as necessary, given their rich experiences in
implementing new programs in the target setting.
Clinical oncologists are responsible for assessing eligibility of cancer patients to
ensure the appropriate patients are selected to receive massage therapy. They will also
provide medical support if patients develop any adverse effects due to massage
therapy such as muscular pain and shortness of breath. Therefore, a meeting with all
10 oncologists will be held to explain the aims and benefits of this massage program.
The frontline nurses will conduct and supervise this massage program while the
volunteers, supervised by their manager from the patient resource centre will perform
the massage interventions. Briefing sessions will be held to explain the purpose of this
innovation to the nurses, manager and the volunteers of the resource centre in order to
gain their support. Training will be provided for the nurses and volunteers with
regards to the knowledge and skills about massage. Details of the briefing and the
training sessions will be described in a later section.
5.1.2 Formation of a working group
A working group will be established to facilitate propagation of information
about this massage program to different stakeholders effectively. The group will be
comprised of an advanced practice nurse (APN), who is familiar with massage and
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responsible for the training sessions, and six senior registered nurses, including the
program coordinator. This group will be responsible for organizing, executing and
evaluating the massage program. They will develop and help revising the EBP
massage guidelines. They will monitor and provide knowledge and skills support for
frontline nurses and volunteers when needed during the implementation period.
5.1.3 Communication process
The communication process will begin with the Ward Manager and the Nurse
Consultant, who are responsible to review new nursing guidelines and innovations
within the department. A meeting will be held with them so that their concern can be
considered and tackled in advance. The working group will convey that anxiety is the
common clinical problem identified among cancer patients receiving chemotherapy.
After that, the evidence-based massage programme will be introduced as a solution to
minimize anxiety in those cancer patients. Training of the nurses and volunteers will
also be discussed. The ward manager and nurse consultant will then be invited to give
their advice about the innovation, and the working group will revise the logistics of
the program accordingly. After gaining the initial support from these key personnel,
the idea of this innovation can then be further disseminated to other stakeholders.
The objectives of this innovation will then be explained in a formal presentation
to others administrators including the Chief of Service, DOM and oncologists. The
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presentation will clearly elaborate the current situation of patients’ anxiety during
chemotherapy. The benefits of massage will be explained with literature evidence
provided. Their concerns and comments will be used to refine the innovation further.
Communication with the frontline nurses is essential as they are the key persons
who will conduct and monitor the massage program. A briefing session will be held to
disseminate the details of the innovation by the program coordinator in the conference
room of the department. The aim and benefits of the proposed program will be
explained. Its workflow will be elaborated and their concerns will be considered in
order to refine the programme.
The manager of the patient resource centre will also be invited to join the nurses
meeting. This will promote communication between them and assist in selecting
eligible volunteers to join the program. As the volunteers are all cancer survivors, the
selection of eligible volunteers will be based on their medical conditions. This is done
to avoid overwhelming them physically due to performing massage intervention. The
selected volunteers will then join other nurses in the training sessions to learn the
details of the massage program. Ten volunteers will then be recruited into this
programme and arranged for the training.
In order to implement the program seamlessly and effectively, a timetable
(appendix M) is stipulated.
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5.2 Staff training program
Before implementing the innovation, two identical two-hour training sessions
will be held in the conference room of the department every Friday from 3:30 pm to
5:30pm. All nurses working in the chemotherapy day ward and the volunteers
recruited will need to attend one of the training sessions. The APN, having rich
clinical experience and knowledge in performing massage to cancer patients, will hold
the training sessions. Theory, technique and benefits of massage will be explained.
The logistics of the program, nursing assessment, evaluation plan and the massage
guidelines will also be elaborated upon. At the end of the training session, both nurses
and volunteers will be asked to demonstrate the massage technique to the APN. A
checklist designed by the working group will be used for assessing their skills in order
to ensure the quality of the massage technique.
5.3 Delivery of intervention
Posters about the program will be placed on the notice board in the
chemotherapy day ward. A leaflet with details of the massage program will be given
to every patient during their admission. If the patients wish to join this program, nurse
will check their eligibility according to the inclusion criteria documented in the
evidence-based guideline. If the patients are eligible, nurse will fill in part 1 of the
assessment form (Appendix N) and file it in the patient’s kardex. Further assessment
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47
for eligibility will be performed by oncologists during their second follow up. This is
to ensure no hidden or recently developed illnesses such as venous thrombosis that are
contraindicated to the massage program. Patients will join the massage program only
after getting approval from the oncologists. Then, a 30-minute massage session will
be performed every 3 weeks on the same day when patients return for chemotherapy.
A maximum of 5 massage sessions will be given.
After getting approval from the oncologists, nurses will complete part 3 of the
assessment form when the patients are admitted to the chemotherapy day ward. They
will explain the procedure of massage to the patients and obtain their informed
consent. Patients will be asked to complete the pre-massage form on measuring their
level of anxiety, nausea and vomiting. Nurses will then supervise the trained
volunteers to perform massage and monitor the patient’s condition during the
intervention. Immediately following the massage therapy, the same measurement will
be collected from patients again. Nurses will document on patients’ kardex if they
develop discomfort during the massage therapy.
5.4 Pilot study
A pilot study should be conducted to test the feasibility and the logistics of this
massage program so as to identify any difficulties related to implementing the
program. It is proposed to conduct a pilot test in the chemotherapy day ward with 10
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48
cancer patients or setting the pilot period for one month, whichever is achieved first.
The trained nurses and volunteers who will work in the day ward during the pilot
period will be responsible for conducting the pilot test. Meetings with the nurses and
volunteers will be conducted to share their opinions and difficulties encountered at the
end of the pilot study period. Revision and refinement of the program will then be
made before the full-scale implementation of this program.
5.5 Ongoing monitoring of the massage program
The working group will monitor the entire innovation process continuously to
ensure the massage program is properly implemented in the target setting. Meetings
with nurses and volunteers will be arranged every 3 months to share their insights on
the massage program. Revisions will be made accordingly.
5.6 Evaluation plan
To determine if the innovation achieves its objectives or not, an outcome
evaluation must be performed.
5.6.1 Identifying outcomes
Anxiety level among cancer patients receiving chemotherapy is set as the
primary patient outcome of this massage program. Patients’ pre and post-massage
anxiety level will be measured by using the Chinese version of State Trait Anxiety
Inventory-State (STAI-S) which is a reliable and validated tool measuring current
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change in anxiety level (Spieberger, 1983). STAI-S was also used by the reviewed
studies to verify the effect of massage in reducing anxiety among cancer patients
(Ahles, et al., 1999; Hernandez, et al., 2004; Bullhult, et al., 2007).
The secondary patient outcome will be the change in severity of nausea and
vomiting for patients during the course of massage therapy. A Numerical rating scale
(NRS), rating from 0 to 10, will be used to measure both the severity of nausea and
vomiting. 0 represents an absence of nausea and vomiting while 10 is an extreme
level of the symptoms. This is a common self-reporting measure to quantify
subjective feelings with established reliability and validity (Ahles,et al., 1999;
Post-White, et al., 2003). Since anxiety is proven to be highly associated with
anticipatory nausea and vomiting, measuring the severity of nausea and vomiting can
also determine whether the massage program achieves its intended effect (Morrow, et
al., 1998).
A successful massage program requires target patients, volunteers and frontline
nurses to accept and participate in this so that it can be developed and implemented
effectively. Therefore, their satisfaction will be measured after the last session of
massage using a 4-point Likert Scale survey. For the patients who have discontinued
treatment prior to the fifth massage session, the survey will be mailed to them in order
to obtain their score of satisfaction.
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5.6.2 Nature and number of clients to be involved
Target patients of this program are adult cancer patients including hematology
malignancy and solid tumor with or without metastasis. The eligibility criteria will be
cancer patients; aged 18 or above; Cantonese- or Mandarin-speaking patients who are
able to read Chinese; and cognitively competent and being admitted to the
chemotherapy day ward receiving chemotherapy. Patients with medical conditions
such as coagulation disorder and bone metastasis will be excluded from the massage
program (Hernandez, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010).
In order to determine whether the anxiety level of cancer patients will be reduced
or not after receiving the massage interventions, an adequate sample size is required.
The number of patients is calculated using the one-sample t test analysis (Russ Lenth,
2009). Taking references from the reviewed studies, a mean difference of 5 between
pre- and post-test on the STAI-S score and a standard deviation of 13 will be used to
calculate the sample size required (Ahles, et al., 1999; Hernandez, et al., 2004). A
paired t test with alpha as 0.05 and power 80% are used. It is assumed that there will
be a 5% drop out rate due to change in patients’ severity of illness causing
discontinuation of chemotherapy and early withdrawal from the massage program.
Therefore, the number of patients required for joining the program is 60. It is
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51
estimated to take six months to recruit 60 cancer patients and have them completed a
maximum of 5 massage sessions.
5.6.3 Data collection and data analysis
The massage sessions will be conducted every 3 weeks during their
chemotherapy treatment. A total of five measurements in pre- and post-massage
STAI-S will be obtained. STAI-S form is a 20-item inventory with each item
measured on a 1-4 numeric rating scale scored from 20-80. The higher the STAI-S
score means the higher the anxiety level of the patients. Since the reviewed studies
reported that massage has an immediate effect on reducing anxiety for cancer patients,
STAI-S scores will be measured immediately before and after each session of
massage (Ahles, et al., 1999; Hernandez, et al., 2004; Listing, et al., 2010; Post-White,
et al., 2003; Sharp, et al., 2010; Soden, et al., 2004).
The Statistical Package for Social Sciences (SPSS) version 17.0 will be used to
analyze the data. Descriptive statistics will be used to summarize patients’
demographic data. The mean STAI-S scores will be generated at each time of
measurement. Two-tailed paired t-test will be used to analyze the STAI-S scores
obtained to determine if the massage program can significantly decrease patients’
level of anxiety or not.
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To evaluate the change in severity of nausea and vomiting during the course of
massage, patients will be asked to grade their feeling of nausea and vomiting by using
NRS (0-10) at 0, 15 and 30 minutes after starting the massage intervention. The mean
scores of NRS-nausea and NRS-vomiting at each time point will be generated
respectively and presented by mean, mean difference and standard deviation using
two-tailed paired t-test.
The satisfaction level of patients, volunteers and nurses towards receiving or
delivering the intervention will be measured using a 4-point Likert scale survey
(4=totally satisfied; 3=satisfied; 2=dissatisfied; 1=totally dissatisfied). The mean
satisfaction score will be calculated and compared.
5.6.4 Basis for an effective change of practice
The massage program will be considered as effective if there is a statistically
significant decrease in patients’ STAI-S score, NRS-nausea and NRS-vomiting after
each massage session with a p-value less than 0.05.
Moreover, if the mean scores of the satisfaction level among patients, volunteers
and nurses are greater than 2, the massage program will be considered successful.
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53
Chapter 6: Conclusion
Cancer patients are experiencing high levels of psychological and
physiological distress during chemotherapy treatment. Of these patients, anxiety is the
most commonly reported symptom from the target population in a local chemotherapy
day ward. It has also been demonstrated that elevated anxiety increases the severity of
chemotherapy side effects, anticipatory nausea and vomiting, thus, impairing cancer
patients’ quality of life to a greater extent. Massage is one of the common CAM that
is effective in reducing anxiety for cancer patients, non-pharmacologically.
After summarizing and synthesizing the data from the 9 reviewed studies, a 30
minute Swedish massage on the lower legs is suggested to be performed on cancer
patients during each cycle of chemotherapy to reduce their anxiety.
An evidence-based guideline on implementing massage therapy for cancer
patients undergoing chemotherapy was set to ensure patient safety and increase
effectiveness in executing the massage program. A detailed implementation plan was
developed to gain support from the stakeholders in the target chemotherapy day ward.
Also, an evaluation plan was designed to assess the effectiveness of this program.
Patients’ level of anxiety, nausea and vomiting will be evaluated. Satisfaction of
patients, volunteers and nurses will also be measured to determine whether the
program can be implemented and developed effectively.
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54
It is hoped that this massage program can be realized and implemented in the
target clinical setting in the future. If so, this program should lead to a significant
improvement in relieving anxiety for cancer patients receiving chemotherapy.
Ultimately, this can result in a better quality of life for cancer patients in Hong Kong.
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55
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Appendix A: Search history
Database 1: Medline (OvidSP) (1946 to July Week 3 2012)
Date of search: 29th
July 2012
Search keywords Results
1. Cancer.mp. or Neoplasms/ 893322
2. Oncology.mp. 50794
3. Carcinoma.mp . 535241
4. Malignancy.mp. 77770
5. Chemotherapy.mp. 258505
6. Massage.mp. 9816
7. Complementary therapies.mp. or Complementary Therapies 13047
8. Alternative therapies.mp . 2579
9. Alternative medicine.mp. 4871
10. Anxiety/ or Anxiety Disorders/ or anxiety.mp. 125830
11. Psychological discomfort.mp. 148
12. Relaxation.mp. 77684
13. Mood disturbance.mp. 888
14. Anticipatory nausea.mp. 170
15. Anticipatory vomiting.mp. 29
16. 1 or 2 or 3 or 4 1467032
17. 6 or 7 or 8 or 9 24872
18. 10 or 11 or 12 or 13 or 14 or 15 214267
19. 16 and 5 and 17 and 18 49
Results
Total journals yielded= 49
Limited electronically to English, Full text & RCT= 13
Manual screened under inclusion and exclusion criteria= 8
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65
Database 2: CINAHL PLUS (EBSCOHost) (1967 to 2012)
Date of search: 29th
July 2012
Search ID # Search Terms Results
S1 Cancer 27396
S2 Neoplasms 33609
S3 Oncology 4411
S4 Carcinoma 5225
S5 Malignancy 958
S6 Chemotherapy 4320
S7 Massage 731
S8 Complementary therapies 316
S9 Alternative therapies 3953
S10 Alternative medicine 921
S11 Anxiety 9437
S12 Anxiety disorders 2029
S13 Psychological discomfort 17
S14 Relaxation 1331
S15 Mood disturbance 101
S16 Anticipatory nausea 12
S17 Anticipatory vomiting 11
S18 S16 or S17 14
S19 S1 or S2 or S3 or S4 or S5 45559
S20 S7 or S8 or S9 or S10 4741
S21 S11 or S12 or S13 or S14 or S15 or S18 12701
S22 S19 and S6 and S20 and S21 14
Results
Total journals yielded= 14
Limited electronically to English, Full text, RCT = 10
Manual screened under inclusion and exclusion criteria= 1
Discarded duplicated studies= 0
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66
Database 3: British Nursing Index (ProQuest)
Date of search: 30th
August, 2012
Set Search Results
S1 Cancer 12441
S2 Neoplasms 11
S3 Oncology 3153
S4 Carcinoma 148
S5 Malignancy 104
S6 Chemotherapy 1332
S7 Massage 436
S8 Complementary therapies 1536
S9 Alternative therapies 2788
S10 Alternative medicine 1092
S11 Anxiety 1925
S12 Anxiety disorders 512
S13 Psychological discomfort 8
S14 Relaxation 282
S15 Mood disturbance 24
S16 Anticipatory nausea 9
S17 Anticipatory vomiting 5
S18 16 or 17 9
S19 1 or 2 or 3 or 4 or 5 12627
S20 S7 or S8 or S9 or S10 2437
S21 S11 or S12 or S13 or S14 or S15 or S18 2649
S22 S19 and S6 and S20 and S21 13
Results
Total journals yielded= 13
Manual screened under inclusion and exclusion criteria= 1
Discarded duplicated studies= 0
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67
Database 4: The Cochrane Library (ProQuest)
Date of search: 30th
August, 2012
ID Search Hits
#1 (Cancer): ti,ab,kw 5732
#2 (Neoplasms): ti,ab,kw 38865
#3 (Oncology): ti,ab,kw 813
#4 (Carcinoma): ti,ab,kw 8898
#5 (Malignancy): ti,ab,kw 26
#6 (Chemotherapy): ti,ab,kw 13891
#7 (Massage): ti,ab,kw 909
#8 (Complementary therapies): ti,ab,kw 359
#9 (Alternative therapies): ti,ab,kw 63
#10 (Alternative medicine): ti,ab,kw 78
#11 (Anxiety) : ti,ab,kw 9584
#12 (Anxiety disorders): ti,ab,kw 3588
#13 (Psychological discomfort): ti,ab,kw 0
#14 (Relaxation): ti,ab,kw 2289
#15 (Mood disturbance): ti,ab,kw 2
#16 (Anticipatory nausea): ti,ab,kw 121
#17 (Anticipatory vomiting): ti,ab,kw 138
#18 (#16 OR #17) 187
#19 (#1 OR #2 OR #3 OR #4 OR #5) 68502
#20 (#7 OR #8 OR #9 OR #10) 1112
#21 (#11 OR #12 OR #13 OR #14 OR #15 OR #18) 19434
#22 (#6 AND #19 AND #20 AND #21) 54
Results
Total journals yielded= 54
Limited electronically to English, Full text & RCT= 20
Manual screened under inclusion and exclusion criteria= 4
Discarded duplicated studies= 0
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68
Database 5: The PsycINFO database (1800s to 2012)
Date of search: 3rd
August, 2012
Set Search Results
S1 Cancer 46704
S2 Neoplasms 27785
S3 Oncology 10658
S4 Carcinoma 1051
S5 Malignancy 1108
S6 Chemotherapy 3418
S7 Massage 1010
S8 Complementary therapies 2681
S9 Alternative therapies 11995
S10 Alternative medicine 10578
S11 Anxiety 157408
S12 Anxiety disorders 88889
S13 Psychological discomfort 1798
S14 Relaxation 13090
S15 Mood disturbance 3741
S16 Anticipatory nausea 137
S17 Anticipatory vomiting 108
S18 16 or 17 145
S19 1 or 2 or 3 or 4 or 5 52757
S20 S7 or S8 or S9 or S10 21200
S21 S11 or S12 or S13 or S14 or S15 or S18 179486
S22 S19 and S6 and S20 and S21 33
Results
Total journals yielded= 33
Limited electronically to English and adulthood (18 Yrs & Older) = 20
Manual screened under inclusion and exclusion criteria= 3
Discarded duplicated studies= 1
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69
Appendix B: Summary of search results
Medline CINAHL
PLUS
British
Nursing
Index
The
Cochrane
Library
The
PsycINFO
database
Electronic search by
keywords
49 14 13 54 33
Limited electronically to
English, adulthood and RCT
13 10 1 20 20
Manual screened under
inclusion and exclusion
criteria
8 1 0 4 3
Discarded duplicated studies 8 0 0 0 1
RCTs identified 8 0 0 0 1
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Appendix C: List of selected studies
1. Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., Dain,
B., Weiss, J. E., Mills, L.& Silberfarb, P. M. (1999). Massage Therapy for
Patients Undergoing Autologous Bone Marrow Transplantation. Journal of Pain
and Symptom Management, 18(3), 157-163.
2. Billhult, A., Bergbon, I. & Stener-Victorin, S. (2007). Massage Relieves Nausea
in Women with Breast Cancer Who Are Undergoing Chemotherapy. The Journal
of Alternative and Complementary Medicine, 13(1), 53-57.
3. Billhult, A., Lindholm, C., Gunnarsson, R. & Stener-Victorin, E. (2008). The
effect of massage in cellular immunity, endocrine and psychological factors in
women with breast cancer- A randomized controlled clinical trial. Autonomic
Neuroscience: Basic and Clinical, 140, 88-95.
4. Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., Weiss,
S., Fletcher, M. A., Schanberg, S., Kuhn, C. & Burman, I. (2004). Breast cancer
patients have improved immune and neuroendocrine functions following massage
therapy. Journal of Psychosomatic Research, 57, 45-52.
5. Jane, S. W., Chen, S. L., Wilkie, D. J., Lin, Y. C., Foreman, S. W., Beaton, R. D.,
Fan, J. Y., Lu, M. Y., Wang, Y. Y., Lin, Y. H. & Liao, M. N. (2011). Effects of
massage on pain, mood status, relaxation, and sleep in Taiwese patients with
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metastatic bone pain: A randomized clinical trial. The Journal of the
International Association for the Study of Pain, 152, 2432-2442.
6. Listing, M., Krohn, M., Liezmann, C., Kim, I., Reisshauer, A., Peters, E., Klapp,
B. F. & Rauchfuss, M. (2010). The efficacy of classical massage on stress
perception and cortisol following primary treatment of breast cancer. Archives of
Womens Mental Health, 13, 165-173.
7. Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C. & Lerner, I.
(2003). Therapeutic Massage and Healing Touch Improve Symptoms in Cancer.
Integrative Cancer Therapies, 2(4), 332-344.
8. Sharp, D. M., Walker, M. B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker,
A. A., Bateman, J., Braid, F., Ellwood, K., Hebblewhite, C., Hope, T., Lines, M.
& Walker, L. G. (2010). A randomized, controlled trial of the psychological
effects of reflexology in early breast cancer. European Journal of Cancer, 46,
312-322.
9. Soden, K., Vincent, K., Craske, S., Lucas, C. & Ashley, S. (2004). A randomized
controlled trial of aromatherapy massage in a hospice setting. Palliative Medicine,
18, 87-92.
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Appendix D: RCTs checklist
CRITICAL APPRAISAL SKILLS PROGRAMME (CASP)
Making sense of evidence
10 questions to help you make sense of a
randomised controlled trial
General comments
Three broad issues need to be considered when appraising research.
A. Are the results of the study valid?
B. What are the results?
C. Will the results help locally?
The questions on the following pages are designed to help you think
about these issues systematically.
The first two questions are screening questions and can be answered
quickly. If the answer to both is "yes", it is worth proceeding with the
remaining questions.
There is a degree of overlap between several of the questions.
You are asked to record a "yes", "no" or "can't tell" to most of the
questions.
A number of italicised hints are given after each question. These are
designed to remind you why the question is important.
These questions are adapted from: Guyatt GH, Sackett DL and Cook
DJ. Users’ guide to the medical literature II. How to use an article about
therapy or prevention. JAMA; 1993; 270(21): 2598-2601 and JAMA
1994; 271(1): 59-63
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A. Are the results of the study valid?
Screening Questions
1. Did the study ask a clearly focused research question?
Consider: if the research question in ‘focus’ in terms of :
- The population studied
- The intervention given
- The outcomes considered
2. Was this a randomized controlled trial (RCT) and was that an appropriate
design?
Consider:
- Why was this study was carried out as an RCT
- If this was the right research approach for the question being asked
Is it worth continuing?
------------------------------------------------------------------------------------------------------
Detailed questions
3. Did the reviewers try to identify all relevant studies?
Consider:
- How participants were allocated to intervention and control groups. Was
the process truly random?
- Whether the method of allocation was described. Was a method used to
balance the randomization, e.g. stratification?
- How the randomization schedule was generated and how a participant was
allocated to a study group?
- If the groups were well balanced. Are any differences between the groups at
entry to the trial reported?
- If there were differences reported that might have explained any outcome(s)
(confounding)
4. Were the participants, staff and study personnel ‘blind’ to participants’
study group?
Consider:
- The fact that blinding is not always possible
- If every effort was made to achieve blinding
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- If you think it matters in this study
- The fact that we are looking for ‘observer bias’
5. Were all of the participants who entered the trial accounted for at its
conclusion?
Consider:
- If any intervention-group participants got a control-group option or vice
versa?
- If all participants were followed up in each study group (was there
loss-to-follow-up)?
- If all the participants’ outcomes were analysed by the groups to which
they were originally allocated (intention to treat analysis)
- What additional information would you like to have seen to make you
feel better about this?
6. Were the participants in all groups followed up and data collected in the
same way?
Consider:
- If, for example, they were reviewed at the same time intervals and if they
received the same amount of attention from researchers and health
workers. Any differences may introduce performance bias.
7. Did the study have enough participants to minimise the play of chance?
Consider:
- Is there a power calculation. This will estimate how many participants
are needed to be reasonably sure of finding something important (if it
really exists and for a given level of uncertainty about the final result)
B. What are the results?
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8. How are the results presented and what is the main result?
Consider:
- If, for example, the results are presented as a proportion of people
experiencing an outcome such as ‘risk’ or as a measurement such as mean
or median differences, or as survival curves and hazards.
- The magnitude of the results and how meaningful they are.
- How you would sum up the ‘bottom-line’ result of the trial in one
sentence?
9 How precise are the results?
Consider:
- If the result is precise enough to make a decision
- If a confidence interval was reported. Would your decision about the
effectiveness of this intervention be the same at the upper confidence limit
as the lower confidence limit?
- If a p-value is reported where confidence intervals are unavailable?
C. Will the results help locally?
10. Were all the important outcomes considered so the results can be applied?
Consider whether:
- The people included in the trial could be different from your population in
ways that might produce different results
- Your local setting differs from that of the trial
- You can provide the same treatment in your setting
Consider outcomes from the point of view of the:
- Individual
- Policy maker and professionals
- Family/carers
- Wider community
Consider whether:
- Any benefit reported outweighs any harm and/or cost. If this information
is not reported, can it be filled in from elsewhere
- Policy or practice should change as a result of the evidence contained in
this trial.
------------------------------------------------------------------------------------------------------
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Appendix E: Level of evidence
SIGN grading system: Level of evidence (Scottish
Intercollegiate Guidelines Network, 2008)
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a
very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk
of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies
High quality case control or cohort studies with a very low risk of
confounding or bias and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relationship is
causal
2- Case control or cohort studies with a high risk of confounding or bias and a
significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
Scottish Intercollegiate Guidelines Network. (2008). Key to evidence statements and
grades of recommendations. Retrieved 30th
August, 2012, from
http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html
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Appendix F: Quality assessment
1) Bibliographic citation: Ahles, et al., 1999 RCT
1. Did the study ask a clearly-focused
question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. But the randomization method was not
described. There was no significant
difference between groups.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at its
conclusion?
Yes. Dropout rate was 2.9%. All participants
were included in the intent-to-treat analysis.
6. Were the participants in all groups
followed up and data collected in
the same way?
Yes. Same measurement tools were used to
collect data for all groups.
7. Did the study have enough
participants to minimize the play of
chance?
Can’t tell. The study did not set minimum
sample size to achieve certain statistical
power. The number of patients was n=16 &
18 each group.
8. How are the results presented, and
what is the main result?
State-Trait Anxiety Inventory-state (STAI-s)
(Higher the score, higher level of anxiety.)
Anxiety level decrease after first and fifth
massage.
9. How precise are these results? Mean change and P value were showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies
and target population were the same.
Level of evidence 1+
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2) Bibliographic citation: Billhult, et al., 2007 RCT
1. Did the study ask a
clearly-focused question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted using sealed
opaque envelops. There was no significant
difference between groups in demographic and
clinical variables.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at
its conclusion?
Yes. All patients were involved and provided
data throughout the study period.
6. Were the participants in all
groups followed up and data
collected in the same way?
Yes Same measurement tools were used to
collect data for all groups.
7. Did the study have enough
participants to minimize the play
of chance?
Can’t tell. The study did not set minimum
sample size to achieve certain statistical power.
The number of patients was n=19 & 20 each
group.
8. How are the results presented,
and what is the main result?
HADS; VAS-nausea (Higher the score, higher
the sense of nausea.) no statistically difference
between groups in HADS.
Massage group statistically reduced sense of
nausea than control group.
9. How precise are these results? Mean change, SD, percentage change and P
value were showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1+
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3) Bibliographic citation: Billhult, et al., 2008 RCT
1. Did the study ask a
clearly-focused question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted using sealed
opaque envelops. There was no significant
difference between groups in demographic
characteristics.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at
its conclusion?
Yes. All participants were involved and
provided data throughout the study period.
6. Were the participants in all
groups followed up and data
collected in the same way?
Yes Same measurement tools were used to
collect data for all groups.
7. Did the study have enough
participants to minimize the play
of chance?
Yes. The number of participants was enough to
achieve a power of 80%. However, the number
of patients was small (n=11/group).
8. How are the results presented,
and what is the main result?
Number of cells in blood specimen; HADS;
STAI-s.
No significant change of number of cells,
anxiety and depression identified between
groups.
9. How precise are these results? Median, 25th
-75th
percentile and P value were
showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1-
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4) Bibliographic citation: Hernandez-Reif, et al., 2004 RCT
1. Did the study ask a
clearly-focused question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted using a flip of
a coin. There was no difference between groups
on stage of cancer, type of surgery, treatments
received and demographic variables.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at
its conclusion?
Yes. All participants followed up until the end
of study.
6. Were the participants in all
groups followed up and data
collected in the same way?
Yes Same measurement tools were used to
collect data for all groups.
7. Did the study have enough
participants to minimize the play
of chance?
Yes. The number of patients was enough (N=34)
to have power of 80%. But the sample size was
small (n=18 & 16 on massage and control
group).
8. How are the results presented,
and what is the main result?
STAI-s (Higher the score, higher level of
anxiety.)
The anxiety level of massage group statistically
lower than the control group.
9. How precise are these results? Mean, percentage change and P value were
showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1++
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5) Bibliographic citation: Jane, et al., 2011 RCT
1. Did the study ask a clearly-focused
question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted using
computerized minimization program. There was
no significant difference between groups on
demographic and medical characteristics.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at its
conclusion?
Yes. Dropout rate was 6.9%. Reasons for the
dropout rate were explained. All participants
were included for the intent-to-treat analysis.
6. Were the participants in all groups
followed up and data collected in
the same way?
Yes. Same measurement tools were used to
collect data for all groups.
7. Did the study have enough
participants to minimize the play of
chance?
Yes. The number of patients was enough
(n=36/group) to have power of 95%.
8. How are the results presented, and
what is the main result?
Present pain intensity (PPI-VAS); Mood-VAS;
Relaxation-VAS; Sleep-VAS (Higher the score,
higher level of the outcome measures.)
The level of pain, mood and relaxation reduced
in massage group than in control group.
9. How precise are these results? Mean, SD, ES, P value and the graphic results
of means scores for the outcome measures over
time were showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1++
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6) Bibliographic citation: Listing, et al., 2010 RCT
1. Did the study ask a
clearly-focused question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted by a simple
randomization list by a study nurse not involved in
the conduction of the study. There was no
significant difference between groups in
socio-demographic and clinical variables.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at
its conclusion?
Yes. Dropout rate was 14.7%. All participants were
included for the intent-to-treat analysis. Difference
of dropouts and completers was compared.
6. Were the participants in all
groups followed up and data
collected in the same way?
Yes. Same measurement tools were used to collect
data for all groups.
7. Did the study have enough
participants to minimize the play
of chance?
Can’t tell. The study did not set minimum sample
size to achieve certain statistical power. The
number of patients was n= 17/group.
8. How are the results presented,
and what is the main result?
Berlin Mood Questionnaire (BMQ)- subscale
anxious depression.
The effect size (ES) of anxious depression in
massage group statistically improved at the end of
the 5 weeks intervention period.
9. How precise are these results? Mean, SD, 95% CI, ES and P value were showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1+
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7) Bibliographic citation: Post-White, et al., 2003 RCT
1. Did the study ask a clearly-focused
question?
Yes
2. Was this a randomized controlled
trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted. But the
method of randomization was not mentioned.
There was no significant difference between
groups in demographic characteristics.
4. Were participants, staff and study
personnel ‘blind’ to participants’
study group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at its
conclusion?
Yes. Dropout rate was 29%. All participants
were included in the intent-to-treat analysis. The
reasons for the dropout rate were discussed.
6. Were the participants in all groups
followed up and data collected in
the same way?
Yes Same measurement tools were used to
collect data for all groups.
7. Did the study have enough
participants to minimize the play
of chance?
No. The number of patients was enough
(>32/group) to have power of 80%.
8. How are the results presented, and
what is the main result?
Brief Profile of Mood States (POMS)-anxiety
subscale.
The mean change of anxiety level in massage
group statistically greater than the control
group.
9. How precise are these results? Mean, standard deviation (SD) and P value were
showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1+
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8) Bibliographic citation: Sharp, et al., 2010 RCT
1. Did the study ask a clearly-focused
question?
Yes
2. Was this a randomized controlled trial
(RCT)?
Yes
3. Were participants appropriately
allocation to intervention and control
groups?
Yes. Randomization was adopted using sealed
opaque envelops. All groups did not differ
significantly for any demographic, clinical or
outcome variables.
4. Were participants, staff and study
personnel ‘blind’ to participants’ study
group?
No. Blinding was impossible to the study
participants.
5. Were all of the participants who
entered the trial accounted for at its
conclusion?
Yes. Dropout rate was 9.3%. All participants
were included in the intent-to-treat analysis.
Reasons for the dropout rate were explained.
6. Were the participants in all groups
followed up and data collected in the
same way?
Yes. Same measurement tools were used for
data collection in all groups.
7. Did the study have enough participants
to minimize the play of chance?
Yes. The number of patients was enough
(>60/group) to provide power of 95%.
8. How are the results presented, and
what is the main result?
HADS; Mood Rating Scale (MRS)-relaxation
subscale. (Higher the score, higher level of
anxiety, depression and relaxation.)
MRS-relaxation score in both reflexology
group and massage group was statistically
higher than control group.
9. How precise are these results? Mean, 95% confidence intervals (CI) and P
value were showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The population of studies’ patients and
target patients were the same.
Level of evidence 1++
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9) Bibliographic citation: Soden, et al., 2004 RCT
1. Did the study ask a
clearly-focused question?
Yes
2. Was this a randomized
controlled trial (RCT)?
Yes
3. Were participants appropriately
allocation to intervention and
control groups?
Yes. Randomization was adopted using concealed
numbered opaque envelopes. There were significant
more women in the control group than intervention
group. But their baseline assessment scores were not
significant differences between groups.
4. Were participants, staff and
study personnel ‘blind’ to
participants’ study group?
No. blinding was impossible to the study
participants. Researchers were blind to the
interventions.
5. Were all of the participants who
entered the trial accounted for at
its conclusion?
Yes. Dropout rate was 14.3%. All participants were
included in the intent-to-treat analysis. Reasons for
the dropout rate were explained.
6. Were the participants in all
groups followed up and data
collected in the same way?
Yes. Same measurement tools were used to collect
data for all groups.
7. Did the study have enough
participants to minimize the
play of chance?
No. The number of patients was small (total N=42)
(<45) and the power of 80% did not reached.
8. How are the results presented,
and what is the main result?
The Hospital Anxiety and Depression Scale (HADS)
(Higher the score, higher level of anxiety and
depression)
Depression score in HADS decreased after 2nd
and
4th
massage.
9. How precise are these results? Mean change, median change and P value were
showed.
10. Were all important outcomes
considered so the results can be
applied?
Yes. The result can be applied as the studies and
target population were the same.
Level of evidence 1-
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Appendix G: Table of evidence 1
Study,
Design,
Evidenc
e level,
Country
No. of patients &
Patients
characteristic
Interventions Compariso
n/control
Length of
follow up
Outcome measures Result/Effect size
1.
Ahles, et
al., 1999
RCT
1+
USA
N=34
Mean age (SD)
=41(9.3)
Diagnosed breast
cancer, lymphoma
and leukemia
admitted for bone
marrow transplant
(BMT) requiring
high dose
chemotherapy
Massager: trained
healing-arts
specialists
n=16
Dropout =0
- 20 minutes
- Swedish
massage
Area:
shoulders,
neck, face and
scalp
- 3 massages
per week
- 3 weeks
n=18
Dropout=1
receive
usual care
in the
autologous
BMT
program
-First massage
- Fifth massage
(mid-treatment
)
-Final massage
(predischarge)
1. State-Trait
Anxiety
Inventory-state
(STAI-s)
2. Beck Depression
Inventory (BDI)
3. Brief Profile of
Mood States
(POMS)
4. Numerical scales
(0-10) of emotional
distress, fatigue,
nausea and pain
Mean changes after first massage:
1. STAI-state: -13.57 (P≦0.0001)
2. NS
3. NS
4. Distress scale: -1.6 (P=0.002)
Fatigue scale: -1.94 (P=0.02)
Nausea scale: -1.94 (P=0.01)
Mean changes after fifth massage (mid-treatment):
1. STAI-state: -7.94 (P=0.02)
2. NS
3: NS
4. NS
Mean changes after last massage (predischarge):
1. NS
2. NS
3. NS
4. Fatigue scale: -1.71 (P=0.03)
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87
Table of evidence 2
Study,
Design,
Evidence
level,
Country
No. of
patients &
Patients
characteristic
Interventions Comparison/contr
ol
Length of follow
up
Outcome
measures
Result/Effect size
2.
Billhult,
et al.,
2007
RCT
1+
Sweden
N=39
Mean age
(SD)=51.8
(9.3)
Women with
breast cancer
undergoing
chemotherap
y which
would be
given every 3
weeks
Massager:
nurses and
nurse’s aids
n=19
Dropout=0
-20 minutes
-Sweden massage
with soft strokes
- Either foot/lower leg
or hand/lower arm
-A cold-press
vegetable oil used
-Total 5 massage
given during
chemotherapy cycle 3
to 7
n=20
Dropout=0
-Visited by a
hospital staff for
20 minutes with
unstructured
conversation
about any subject,
but did not
receive massage
-VAS scores of
nausea and
anxiety before
and immediate
after each
intervention
-HADS assessed
before the first
and the last
intervention
1. VAS of
nausea and
anxiety
2. The
Hospital
Anxiety and
Depression
scale (HADS)
1. Mean change of VAS nausea in
massage group vs mean change in control
group:
73.2% vs 49.5% (P=0.025)
No statistically significant differences in
anxiety between 2 groups.
2. No statistically differences between
groups in changed in HAD anxiety and
depression.
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88
Table of evidence 3
Study,
Design,
Evidence
level,
Country
No. of patients &
Patients
characteristic
Interventions Comparison
/control
Length of follow
up
Outcome measures Result/Effect size
3.
Billhult,
et al.,
2008
RCT
1-
Sweden
N=22
Mean age (SD)
=62.5 (7)
Women with
breast cancer
undergoing
radiation therapy
Massager: trained
registered nurses
n=11
Dropout=0
-20 minutes
effleurage
massage
-either
foot/lower leg
or hand/lower
arm
-10 times
during 3 to 4
weeks
n=11
Dropout=0
-20 minutes
visit by
hospital
staff with
unstructured
conversatio
n about any
topic
-Blood samples
taken before the
first and last
massage/control
visit
-HADS and STAI
taken prior the
first and last
massage/control
visit
1. Peripheral blood
sample on the number
of NK cell and T helper
cell
2. HADS
3. STAI
1. No statistically differences on
peripheral blood concentration of NK cell
and T helper cell between groups
2. No statistically differences on HADS
between groups
3. No statistically differences on STAI
between groups
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89
Table of evidence 4
Study,
Design,
Evidenc
e level,
Country
No. of patients
& Patients
characteristic
Intervention
s
Comparison
/control
Length of
follow up
Outcome
measures
Result
(Pre/post % change in intervention vs control)
4.
Hernand
ez-Reif,
et al.,
2004
RCT
1++
USA
N=34
Mean age
(SD)=53(10.4)
Women with
stage 1 or 2
breast cancer
after surgery
Massager:
trained
massage
therapist
n=18
Dropout=0
-Swedish
massage
-head/neck,
shoulder,
back, arms
and
legs/feet
-30 minutes
-3 times per
week
-5 weeks
n=16
Dropout=0
Receive
standard
medical
care
-First day of
massage
-Last day of
massage
(pretest of
outcome
measures 3,
4, 5 were
performed
before the 1st
day of
massage and
posttest
performed
after last day
of massage)
1. STAI
2. POMS
3. Symptom
Checklist-90-R
(SCL-90-R)
4. Urinary
biochemistry
on dopamine
and serotonin
5. Serum level
of natural
killer (NK) cell
and
lymphocytes
1. Significant improvement in STAI at the first and the
last day of massage.
First day : ↓ 27% vs ↓6% (P<0.01)
Last day: ↓ 29% vs ↓6% (P<0.01)
2. Significantly decrease at the first day of massage:
POMS-Depression: ↓75% vs ↓25% (P<0.01)
And POMS-Anger: ↓80% vs ↓17% (P<0.01)
% change from means difference of first-last day measures
in intervention group for the longer term effect:
3. Depression ↓46% (P<0.05), Hostility ↓50% (P<0.05)
4. Urine level of dopamine: ↑26% (P<0.05), serotonin ↑60%
(P<0.05)
5. Serum NK cells↑12% (P<0.05), lymphocytes ↑10%
(P<0.05)
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Table of evidence 5
Study,
Design,
Evidence
level,
Country
No. of
patients &
Patients
characteristic
Interventions Comparison
/control
Length of follow up Outcome measures Effect size between massage group and
control group
5.
Jane, et
al., 2011
RCT
1++
Taiwan
N= 72
Mean age
(SD) = 50
(10.6)
Female: 58%
Cancer
patients who
were able to
speak and
read Chinese
with bone
metastases
Massager:
nurses
n= 36
Dropout= 2
-45 minutes
full body
massage
-3
consecutive
sessions
n= 36
Dropout= 3
-Presence of
a caring
therapist for
45 minutes
(social
attention)
-Baseline
assessment on Day
1 (T0)
-Pre & posttest
taken on Day 2
(T1), Day 3 (T2)
and Day 4 (T3)
-Last measures on
Relaxation-VAS &
Sleep-VAS done
on Day 5 (T4)
1. Present pain intensity
(PPI-VAS)
2. Mood-VAS
3. Relaxation-VAS
All outcome measures showed significant
improvement at measurement time points
T1, T2 and T3.
1. PPI-VAS: ES > 0.69 (P= 0.01)
2. Mood-VAS: ES > 0.49 (P < 0.04)
3. Relaxation-VAS: ES > 0.45 (P < 0.03)
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91
Table of evidence 6
Study,
Design,
Evidence
level,
Country
No. of patients &
Patients
characteristic
Interventions Comparison
/control
Length of
follow up
Outcome measures Result/Effect size
6.
Listing, et
al., 2010
RCT
1+
Germany
N=34
Mean age(SD)=
59.7(11.8)
Women with
primary breast
cancer
Massager:
licensed, trained
female massage
therapist
n=17
Dropout=1
-Biweekly
-30 minutes
Swedish
massage to the
back, neck and
head
-5 weeks
n=17
Dropout=4
Routine
health care
T1: baseline
T2: at the
end of the 5
week
intervention
T3: 6 weeks
after T2
1. Perceived Stress
Questionnaire (PSQ)
2. Berlin Mood
Questionnaire (BMQ)
3. Serum cortisol and
serotonin measure
1. PSQ-worries decreased significantly in
intervention group from 37.5 (T1)to 31.3(T2)
(P=0.047) and remain low 28.3(T3) (P=0.003)
2. At T2, BMQ-Anger Effect size(ES) =0.82
(P<0.05)
At T2, BMQ-anxious depression ES=0.90
(P<0.05)
At T3, BMQ-Tiredness mean difference
between massage and control group= -15.73
(P<0.05)
3. Serum cortisol level decreased significantly at
T2 (P=0.03). NS in serum serotonin level.
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92
Table of evidence 7
Study,
Design,
Evidence
level,
Country
No. of
patients &
Patients
characteris
tic
Interventions Compariso
n/control
Length of follow
up
Outcome
measures
Result/Effect size
7.
Post-White,
et al., 2003
RCT
(crossover)
1+
USA
N=230
Mean age
(SD) =
54.7(11.7)
Female:
86.1%
Adult
out-patient
s receiving
chemother
apy
Massager:
Registered
nurses
-4 weekly
-45 minutes
A: Therapeutic
massage (MT)
n=78
-Swedish massage
on whole body
with massage gel
B: Healing touch
(HT)
n=77
C: Caring
presence (P)
n=75
Standard
care
(crossover
from
interventio
n groups)
- Outcome
measures 1& 2
were measure
before and after
each
intervention.
- Outcome
measures 3, 4, 5
measures before
session 1 and
each 4-week
crossover period
session 4, 5, 8.
1. Heart rate,
respiratory rate
and blood
pressure
2. 0-10 scale of
current pain and
current nausea
3. Brief Pain
Index (BPI)
4. Brief Nausea
Index (BNI)
5. POMS
1. MT and HT reduced respiratory rate (P<0.001),
heart rate (P<0.001) and systolic (P<0.001) and
diastolic pressure (P<0.001)
2. MT (P<0.001) and HT (P<0.011) have
significantly lower in pain level. There is no
significantly different in nausea scale in MT and HT.
3. NS
4. NS
Mean of MT at session 1→4 vs control at session
1→4:
5. POMS-Mood disturbance: 32.9→17.8 vs
31.0→29.6 (P=0.004)
POMS-Anxiety: 11.1→7.6 vs 10.8→9.6 (P=0.02)
HT reduced total mood disturbance (P=0.003) and
fatigue (P=0.028)
Presence had no different than control in POMS
measures.
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93
Table of evidence 8
Study,
Design,
Evidenc
e level,
Country
No. of
patients &
Patients
characteristi
c
Interventions Compari
son/contr
ol
Length of
follow up
Outcome measures Result/Effect size
8.
Sharp, et
al., 2010
RCT
1++
UK
N=183
Mean age
(SD)=
58.78
(10.31)
Breast
cancer
female 6
weeks post
breast
surgery
Massager:
not mention
Intervention
A: n=60
Dropout=3
reflexology
on foot plus
usual care
Intervention
B: n=61
Dropout=3
Scalp
massage plus
usual care
-1 hour
session
- Weekly
-8 weeks
Intervent
ion C:
n=62
dropout=
11
Usual
care
- Primary
end-point: 18
weeks after
surgery (4
week after
last massage)
Secondary
end-point: 24
weeks after
surgery (10
week after
last massage)
1st outcome:
1. The Trial Outcome
Index (TOI):
composed of the sum
of scores on the
physical, functional
and breast cancer
concern subscales.
2nd
outcome:
2. Mood Rating Scale
(MRS)
3. HADS
Means difference at primary end-point:
1. Intervention B has significant improvement on
TOI: 4.01 (P=0.03)
2. Both intervention A and B have significant
improvement in MRS-relaxation:
Intervention A-C: 26.92 (P≦0.0005)
Intervention B-C: 26.21 (P≦0.0005)
Intervention B has significant improvement in
MRS-easy goingness:
Intervention B-control: 24.8 (P≦0.0005)
3. NS
Means difference at secondary end-point:
1. Intervention A has significant improvement on
TOI: 5.4 (P=0.02)
2. Intervention A has significant improvement on
MRS-relaxation: 18.23 (P=0.02)
3. NS
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94
Table of evidence 9
Study,
Design,
Evidence
level,
Country
No. of
patients &
Patients
characteristic
Interventions Comparison
/ control
Length of
follow up
Outcome measures Result/
Effect size
9.
Soden, et
al., 2004
RCT
1-
UK
N=42
Aged:44-85
years
Median: 73
years
Female: 76%
Dropout: 6
All kind of
cancer
diagnosis
Metastatic
disease: 55%
Massager:
not
mentioned
- 30 minutes
- Back
massage
- Weekly
- 4 week
Aromatherapy
group: (AT) n=
16 massage
with lavender
essential oil
Massage
group: (MT)
n= 13 massage
with inert
carrier oil
Massager: not
mentioned.
Usual care
N=13
Did not
receive any
massage
during the
study period
Weekly
after every
massage
1st outcome:
1. Visual Analogue Scale
(VAS) of pain intensity
2nd
outcome:
2. HADS
1. Statistically improvement on the mean
change in pain VAS scores compared
with baseline in second massage: AT:
-1.15 (P=0.01)
2. MT have significant improvement on
median HAD scores in second and fourth
treatments:
2nd
week: -2.0 (P≦0.05)
4th
week: -1.5 (P≦0.01)
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95
Appendix H: Table of summary for the studies’ results
Citations Level of
evidence
Participants
(Sample size)
Mean age
(SD)
Area of massage Duration Frequency Massager Follow-up Outcome
measures
Results
1. Ahles, et al.,
1999
1+
USA
BMT
N=34
41
(9.3)
Swedish on
shoulders, neck, face
and scalp
20 min 3/week,
3 wks
Trained healing arts
specialists
1st, 5th & final
massage
STAI-s Improve STAI-s
after 1st
and 5th
massage
2. Billhult, et
al., 2007
1+
Sweden
Breast cancer
female on
chemo
N=39
51.8
(9.3)
Swedish on either
foot/lower leg or
hand/lower arm
20 min Q3wks,
on cycle 3-7
Nurses VAS: Before and after
each massage
HADS: before the 1st
and after last massage
HADS
Anxiety and
Nausea-VAS
Improve in
VAS-nausea
3. Bullhult, et
al., 2008
1-
Sweden
Breast cancer
female in RT
N=22
62.5
(7)
Swedish on either
foot/lower leg or
hand/lower arm
20 min 10 time
during 3-4
wks
Nurses Before the 1st and after
the last massage
HADS
STAI
No significant
improvement
4. Hernandez,
et al., 2004
1++
USA
Breast cancer
female
N=34
53
(10.4)
Swedish on head/
neck, shoulder, back,
arms, leg/feet
30 min 3/week,
5 wks
Trained massage
therapists
1st and last day of
massage
STAI-s Improve STAI-s in
both follow up
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96
Citations Level of
evidence
Participants
(Sample size)
Mean age
(SD)
Area of massage Duration Frequency Massager Follow-up Outcome
measures
Results
5. Jane, et al.,
2011
1++
Taiwan
Cancer patient
with bone met
N=72
50
(10.6)
Swedish on whole
body
45min 3 consecutive
session
Nurses Baseline: day 1
Mood-VAS: Day 2, 3, 4
Relaxation-VAS: Day 5
VAS-Mood
VAS-Relaxation
Improve mood and
relaxation on day 2,
3, 4.
6. Listing, et
al., 2010
1+
Germany
Breast cancer
female
N=34
59.7
(11.8)
Swedish on back,
neck and hand
30 min Biweekly,
5 wks
Licensed trained
massage therapists
Baseline, at the end
and 6 wk after final
massage
BMQ-anxious
depression
Improve BMQ-
anxious depression at
the end of massage
7. Post-White,
et al., 2003
1+
USA
Chemo pt
N=230
54.7
(11.7)
Swedish on whole
body
45 min Weekly,
4 wks
Nurses Before 1st and after
4th massage
POMS-anxiety
subscale
Improve POMS-
anxiety
8. Sharp, et al.,
2010
1++
UK
Breast cancer
female
N=183
58.78
(10.31)
Scalp 1 hr Weekly,
8 wks
Not mentioned 4 week and 10 week
after last massage
HADS
MRS-relaxation
subscale
Improve MRS-
relaxation score after
4 weeks
9. Soden, et al.,
2004
1-
UK
All cancer
N=42
Median:
73
Back 30 min Weekly,
4 wks
Not mentioned Weekly HADS Improve in
HADS-depression on
2nd
& 4th
week
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Appendix I:
Estimated expenses that can be saved by reducing use of potent
anti-emetics
Choice of potent anti-emetics:
Anti-emetics Dosage Frequency #Cost for 1 day Duration Cost for 3 days per patient
Navoban 5mg Daily $63.5 3 days $63.5 x3 = $190.5
Kytril 1mg Twice a
day
$71.4 x2
= $142.8
3 days $142.8 x3 = $428.4
Zofran 8mg Twice a
day
$20 x2
= $40
3 days $40 x3 = $120
# the price of medication is based on the Drug formulary at the Hospital Authority.
The average costs of taking these drugs for 3 days per patient:
($190.5+$428.4+$120)/3 = $246.3
Assuming 20% of total patients (233 patients) joining the program per year do
not require the use of these potent anti-emetics after receiving massage,
The estimated costs saved: $246.3 x233 ~ $57,000
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Appendix J
Budget plan for implementing the massage program
Budget Plan Estimated Cost
Training
-Venue for holding the briefing session $0
-Printing notes for the training:
RNs x15
Volunteers x10
$5/ person x25 =
$125
-Computer and projector device $0
Total estimated expense for training: $125
Running cost
Printed materials:
Posters and leaflet
Consent
Self-design nurse assessment checklist $5/ person
-Massage oil (lubricant) $5/ person
Estimated expenses for running the program
per patient: $10/person
Estimated expenses for the program per year:
Total patients admitted to the day ward in the past year 11,692
Assuming half of the total patients
experience anxious:
11,692 / 2 5,846
If 20% of the anxious patients are
eligible and willing to join the program:
5,846 x 20% 1,169
Estimated expenses for running the
program for a year:
$125 + ($10 x 1,169) ~ $12,000
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Appendix K: Grade of recommendation
SIGN grading system: Grade of Recommendation
(Scottish Intercollegiate Guidelines Network, 2008)
A At least one meta analysis, systematic review, or RCT rated as 1++,
and directly applicable to the target population; or
A systematic review of RCTs or a body of evidence consisting
principally of studies rated as 1+, directly applicable to the target
population, and demonstrating overall consistency of results.
B A body of evidence including studies rated as 2++, directly
applicable to the target population, and demonstrating overall
consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable
to the target population and demonstrating overall consistency of
results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
D (GPP) Recommended best practice based on the clinical experience of the
guideline development group
GPP: Good practice points
Scottish Intercollegiate Guidelines Network. (2008). Key to evidence statements and
grades of recommendations. Retrieved 30th
August, 2012, from
http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html
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Appendix L
Evidence-based practice guideline of massage for cancer
patients receiving chemotherapy
Introduction
Cancer patients receiving chemotherapy experience various treatment-related
side effects including nausea, anxiety, impairing their quality of life. A study
(Molassiotis, et al., 2002) showed that there were 15-40% cancer patients suffering
from psychological disorders related to anxiety and depression during chemotherapy.
The use of massage for cancer patients receiving chemotherapy can greatly improve
their anxiety, mood status and severity of nausea and vomiting, hence, improving
their quality of life (Corbin, 2005). The following evidence-based practice (EBP)
guideline is developed for the use of massage on adult cancer patients receiving
chemotherapy to reduce anxiety in the chemotherapy day ward. This EBP guideline is
developed based on the evidence generated from nine RCTs. The recommendation
and the level of evidence are graded according to the Scottish Intercollegiate
Guideline Network (SIGN, 2008).
Aim
The aim of this guideline is to implement feasible and effective massage
interventions to reduce anxiety for cancer patient receiving chemotherapy in an
outpatient clinic setting.
Objectives
To provide a consistent framework for implementation of safe and effective massage
therapy to cancer patients to reduce their anxiety from receiving chemotherapy.
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Target population
The massage therapy is applicable to both male and female adult cancer patients
who are receiving chemotherapy in the chemotherapy day ward.
Inclusive criteria
- Aged 18 or above
- Cantonese- and Mandarin-speaking patients who are able to read Chinese.
- Cognitively competent
Exclusive criteria
- Coagulation disorder
- Spinal cord injury
- Venous thrombosis
- Bone metastasis
- Peripheral neuropathy
- Radiation dermatitis
- Open wound over lower limbs
(Recommendation 1.0)
Roles and responsibilities of nurses
1. Introduce and explain the massage program to potential patients and give a
pamphlet on the massage therapy to them.
2. Seek oncologist’s approval for the selected patient to receive massage therapy
during patient’s second chemotherapy follow-up by asking oncologist to sign on
the assessment form attached on patients’ medical record.
3. Reconfirm eligibility of patient during the next admission to day ward for
chemotherapy and obtain a written consent.
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4. Ask patient to complete the State-Trait Anxiety Inventory (STAI) assessment
form on admission and after receiving the massage to measure patient’s level of
anxiety. (Recommendation 4.0)
5. Check patient’s vital signs including blood pressure, pulse, respiratory rate and
oxygen saturation and document in the assessment form before and after the
massage intervention.
6. Refer appropriate patient to the massagist for therapy.
7. Educate patient to report any discomfort or abnormalities when receiving
massage therapy.
8. Observe patient’s response to the therapy for at least 5 minutes after
commencement for the first treatment and as necessary.
9. Monitor and manage patients with massage-induced complications (see Table 1).
10. Refer patients to oncologist for subsequent treatment if necessary.
The massage protocol
1. 30 minutes Swedish massage is recommended to perform on patient’s lower
limbs every 3 weeks. (Recommendations 2.0 and 3.0)
2. Maximum 5 sessions will be given to cancer patients or until patient’s
chemotherapy treatment completed.
3. Step of massage (Table 2.):
I. Strokes from the ventral side of the foot up around the knee and back to the
foot.
II. Small circular movements and kneading on the side of the calf from the foot
to the knee.
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III. Circular stroking around the sides of the knee and the ankle.
IV. Stroking on the ventral side of the foot.
V. Strokes on the dorsal side of the foot.
VI. Strokes from the ventral side of the foot up around the knee and back to the
foot.
VII. Repeat step I to VI on another leg.
*The step of massage is based on the study (Billhult, et al., 2008). *
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Evidence of the recommendations
Recommendation 1.0
Nursing assessment should be performed to exclude high risk patients from
joining the massage program. (Grade of recommendation: A)
Patients with medical conditions including coagulation disorder, spinal cord
injury, thrombosis, bone metastasis, peripheral neuropathy, radiation dermatitis and
open wound over lower limbs are excluded from receiving massage in four of the
reviewed RCTs(Hernandez-Reif, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010;
Listing, et al., 2010). This is necessary as these conditions may heighten the risk of
massage complications such as neuropathy damage, hematoma, bleeding and
dislodging of deep venous thrombosis causing embolism (Hernandez-Reif, et al, 2004;
Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010) (1++; 1++; 1++; 1+).
Recommendation 2.0
Swedish massage is recommended to perform on patient’s lower limbs. (Grade of
recommendation: A)
No complication such as fractures, dislocations, nerve damage and pulmonary
embolism were reported from participants in seven reviewed RCTs which used
Swedish massage as their interventions. (Ahles, et al., 1999; Billhult, et al., 2007;
Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al.,
2010; Post-White, et al., 2003). (1+; 1+; 1-; 1++; 1++; 1+; 1+)
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Recommendation 3.0
The duration of massage therapy is recommended as 30 minutes. (Grade of
recommendation: A)
Six reviewed studies used 20-30 minute massage and five of them reported to
have positive effects in reducing level of anxiety and sense of nausea for cancer
patients (Ahles, et al., Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif, et
al., 2004; Listing, et al., 2010; Soden, et al., 2004). The immediate short-term (30 min)
benefits of massage therapy is well proved to reduce anxiety for cancer patients
(Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden et al., 2004). (1++; 1+; 1- )
Recommendation 4.0
The State-Trait Anxiety Inventory (STAI-S) measuring tool should be used to
measure the patient’s level of anxiety before and after the massage so as to
evaluate the effectiveness of this massage program. (Grade of recommendation:
A)
Five reviewed RCTs used one-dimensional self assessment tools to measure the
subjective feeling of anxiety for cancer patients (Ahles, et al., 1999; Billhult, et al.,
2007; Bullhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011). Three of
them used STAI-S assessment tool to measure anxiety level for cancer patients and
resulted in decrease in their anxiety level (Ahles, et al., 1999; Billhult, et al., 2008;
Hernandez-Reif, et al., 2004). STAI-S is a valid and reliable one-dimensional
assessment tool that is short and easy for cancer patients to complete. (1+; 1-; 1++)
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Table 1. Potential massage-induced complications, manifestations and
management
Potential
complications
Patient Manifestation Management
Petechia
Bruise
Hematoma
Blue or purple
discoloration on
skin
Dizziness
Decrease in blood
pressure
Tachycardia
Stop the massage.
Assess the possible cause of skin rash.
Maintain a patent intravenous line.
Inform doctor.
Muscular
pain over the
site where
massage is
applied
Pain
Stop the massage.
Assess the cause of pain.
Immobilize the leg.
Inform doctor if necessary.
Embolism Shortness of breath
Tachycardia
Dramatically change
in blood pressure
Stop the massage.
Lie down the patient.
Close monitor patient’s vital signs
including blood pressure, pulse, oxygen
saturation (SpO2), and temperature.
Maintain a patent intravenous line.
Provide oxygen therapy if necessary.
Provide basic life support.
Inform doctor.
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Table 2. Step of massage
Apply to left / right leg
VII. Repeat step I to VI on another leg
IV. Strokes on the ventral side of the foot.
VI. Strokes from the ventral side of the foot up
around the knee and back to the foot.
I. Strokes from the ventral side of the foot up
around the knee and back to the foot.
II. Small circular movements and kneading on
the side of the calf from the foot to the
knee.
III. Circular stroking around the sides of the
knee and the ankle.
Stroking on the ventral side of the
foot.
V. Strokes on the dorsal side of the foot.
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Reference of the guideline:
1. Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., Dain,
B., Weiss, J. E., Mills, L.& Silberfarb, P. M. (1999). Massage Therapy for
Patients Undergoing Autologous Bone Marrow Transplantation. Journal of Pain
and Symptom Management, 18(3), 157-163.
2. Billhult, A., Bergbon, I. & Stener-Victorin, S. (2007). Massage Relieves Nausea
in Women with Breast Cancer Who Are Undergoing Chemotherapy. The Journal
of Alternative and Complementary Medicine, 13(1), 53-57.
3. Billhult, A., Lindholm, C., Gunnarsson, R. & Stener-Victorin, E. (2008). The
effect of massage in cellular immunity, endocrine and psychological factors in
women with breast cancer- A randomized controlled clinical trial. Autonomic
Neuroscience: Basic and Clinical, 140, 88-95.
4. Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., Weiss,
S., Fletcher, M. A., Schanberg, S., Kuhn, C. & Burman, I. (2004). Breast cancer
patients have improved immune and neuroendocrine functions following massage
therapy. Journal of Psychosomatic Research, 57, 45-52.
5. Jane, S. W., Chen, S. L., Wilkie, D. J., Lin, Y. C., Foreman, S. W., Beaton, R. D.,
Fan, J. Y., Lu, M. Y., Wang, Y. Y., Lin, Y. H. & Liao, M. N. (2011). Effects of
massage on pain, mood status, relaxation, and sleep in Taiwese patients with
metastatic bone pain: A randomized clinical trial. The Journal of the
International Association for the Study of Pain, 152, 2432-2442.
6. Listing, M., Krohn, M., Liezmann, C., Kim, I., Reisshauer, A., Peters, E., Klapp,
B. F. & Rauchfuss, M. (2010). The efficacy of classical massage on stress
perception and cortisol following primary treatment of breast cancer. Archives of
Womens Mental Health, 13, 165-173.
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109
7. Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C. & Lerner, I.
(2003). Therapeutic Massage and Healing Touch Improve Symptoms in Cancer.
Integrative Cancer Therapies, 2(4), 332-344.
8. Sharp, D. M., Walker, M. B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker,
A. A., Bateman, J., Braid, F., Ellwood, K., Hebblewhite, C., Hope, T., Lines, M.
& Walker, L. G. (2010). A randomized, controlled trial of the psychological
effects of reflexology in early breast cancer. European Journal of Cancer, 46,
312-322.
9. Soden, K., Vincent, K., Craske, S., Lucas, C. & Ashley, S. (2004). A randomized
controlled trial of aromatherapy massage in a hospice setting. Palliative Medicine,
18, 87-92.
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Appendix M: Timetable for implementation of the massage program
Sep 2013 Oct 2013 Nov 2013 Dec 2013 Jan 2014 to Jun 2014 Jul 2014 Aug 2014
1. Forming a team of core members
2. Seeking administrator’s approval
3. Refining the guideline
4. Training to nurses and volunteers
5. Pilot study
6. Amending guideline and logistics of
the program
7. Implementing the program
8. Evaluating the outcome
9. Generating report and disseminating
the finding
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Appendix N
Assessment form for the massage program
Part 1
Patient Diagnosis: ________________ No. of massage sessions received:
Name of chemotherapy received:
No. of cycle of chemotherapy: Date of receiving massage:
*********************************************************************
Part 2
Medical assessment
(Completed by oncologists during patient’s follow-up)
No Yes Remarks
1. Does the patient have coagulation disorder?
2. Does the patient have history of spinal cord injury?
3. Does the patient have history of thrombosis?
4. Does the patient have bone metastasis?
5. Does the patient experience chemotherapy-induced
peripheral neuropathy?
Can the patient receive massage therapy? No Yes
No massage therapy is allowed if any “yes” on the above items.
Doctor’s signature: Date:
*********************************************************************
Gum label
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Assessment form for massage program Page. 2
**********************************************************
Part 3
Nursing integrated assessment
(Complete by nurses on the same day of massage)
1. Is an informed consent being obtained? No Yes
2. Is the patient receiving concurrent chemotherapy and radiation? No Yes
Lower limbs skin Assessment:
1. Skin integrity Wounded Intact
2. Skin color Pale Erythema Cyanotic Pink
3. Skin texture Dry Scaly Oily Normal
4. Skin turgor Edema normal
Special Medication History:
Use of opioids: No Yes Please specify type, dosage, frequency:
Use of anxiolytics: No Yes Please specify type, dosage, frequency:
Use of antiemetics: No Yes Please specify type, dosage, frequency:
Blood Result:
Platelet count:
Clotting:
Can the patient receive massage therapy? No Yes
Pre-massage vital signs: BP: mmHg P: /min SpO2: %
Post-massage vital signs: BP: mmHg P: /min SpO2: %
Remarks:
Nurse’s signature: Date:
*******************************************************************
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Assessment form for massage program Part 4 Page. 3
按摩前評估 Pre-massage measurement form(由病人填寫)
(一) 情景特質焦慮量表-情境焦慮部分 (STAI-S)
以下是一般人常用來描述自己感受的句子,請仔細閱讀每一句,然後根據你現在的感受 (即此時
此刻的感受),圈選一個最適當的答案。
完全不符合
有
些
符
合
頗
為
符
合
極
為
符
合
1 我現在覺得心裡平靜 # 1 2 3 4
2 我現在覺得安全 # 1 2 3 4
3 我現在是緊繃的 1 2 3 4
4 我現在覺得很緊張 1 2 3 4
5 我現在覺得很放鬆 # 1 2 3 4
6 我感到困擾 1 2 3 4
7 我現在正擔心可能將有不幸的事會發生 1 2 3 4
8 我現在覺醒很滿意 # 1 2 3 4
9 我現在覺得害怕 1 2 3 4
10 我現在覺得心裡舒適 # 1 2 3 4
11 我覺得我是自信的 # 1 2 3 4
12 我覺得我很神經質 1 2 3 4
13 我常常是戰戰兢兢的 1 2 3 4
14 我覺得自己優柔寡斷 1 2 3 4
15 我現在是放鬆的 # 1 2 3 4
16 我現在覺得很滿足 # 1 2 3 4
17 我現在是憂慮的 1 2 3 4
18 我現在覺得困惑 1 2 3 4
19 我現在覺得穩定 # 1 2 3 4
20 我現在覺得很愉快 # 1 2 3 4
# 為反向計分
********************************************************************
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Assessment form for massage program Part 5 Page. 4
按摩後評估 Post-massage measurement form(由病人填寫)
(一) 情景特質焦慮量表-情境焦慮部分 (STAI-S)
以下是一般人常用來描述自己感受的句子,請仔細閱讀每一句,然後根據你現在的感受 (即此時
此刻的感受),圈選一個最適當的答案。
完全不符合
有
些
符
合 頗
為
符
合
極
為
符
合
1 我現在覺得心裡平靜 # 1 2 3 4
2 我現在覺得安全 # 1 2 3 4
3 我現在是緊繃的 1 2 3 4
4 我現在覺得很緊張 1 2 3 4
5 我現在覺得很放鬆 # 1 2 3 4
6 我感到困擾 1 2 3 4
7 我現在正擔心可能將有不幸的事會發生 1 2 3 4
8 我現在覺醒很滿意 # 1 2 3 4
9 我現在覺得害怕 1 2 3 4
10 我現在覺得心裡舒適 # 1 2 3 4
11 我覺得我是自信的 # 1 2 3 4
12 我覺得我很神經質 1 2 3 4
13 我常常是戰戰兢兢的 1 2 3 4
14 我覺得自己優柔寡斷 1 2 3 4
15 我現在是放鬆的 # 1 2 3 4
16 我現在覺得很滿足 # 1 2 3 4
17 我現在是憂慮的 1 2 3 4
18 我現在覺得困惑 1 2 3 4
19 我現在覺得穩定 # 1 2 3 4
20 我現在覺得很愉快 # 1 2 3 4
# 為反向計分
********************************************************************
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Assessment form for massage program Part 5 Page. 5
按摩後評估 Post-massage measurement form(由病人填寫)
(二) 噁心評估量表 Numerical Rating Scale (NRS-Nausea)
請以 0-10 分之分數,表達出你於按摩時的不同時間之噁心嚴重度。
(0 分為不噁心,10 分為非常噁心。)
按摩前 (0 分鐘):
開始按摩後 (15 分鐘):
開始按摩後 (30 分鐘):
(三) 嘔吐評估量表 Numerical Rating Scale (NRS-Vomiting)
請以 0-10 分之分數,表達出你於按摩時的不同時間之嘔吐嚴重度。
(0 分為沒有嘔吐,10 分為嚴重嘔吐。)
按摩前 (0 分鐘):
開始按摩後 (15 分鐘):
開始按摩後 (30 分鐘):
~問卷完~
~多謝參與~