Using the Clinical Research Network for psychosocial research: lessons learned from two observational studies

Confidential: For Review O

nly

Using the Clinical Research Network for psychosocial

research: lessons learned from two observational studies

Journal: BMJ Supportive & Palliative Care

Manuscript ID: bmjspcare-2012-000410.R1

Article Type: Features

Date Submitted by the Author: n/a

Complete List of Authors: Wright, Penny; University of Leeds, Leeds Institute of Cancer Studies and Pathology Fenlon, Debbie; University of Southampton, Faculty of Health Sciences Jones, Helen; University of Leeds, Leeds Institute of Cancer Studies and Pathology Foster, Claire; University of Southampton, Faculty of Health Sciences

Ashley, Laura; University of Leeds, Leeds Institute of Cancer Studies and Pathology Chivers Seymour, Kim; University of Southampton, Faculty of Health Sciences Velikova, Galina; University of Leeds, Leeds Institute of Cancer Studies and Pathology Okamoto, Ikumi; University of Southampton, Academic Unit of Primary Care and Population Sciences Brown, Julia; University of Leeds, Leeds Institute of Clinical Trials Research

Keywords: Cancer, Methodological research, Survivorship

http://mc.manuscriptcentral.com/bmjspcare

BMJ Supportive & Palliative Care


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Using the Clinical Research Network for psychosocial research:

lessons learned from two observational studies

Penny Wright*1, Deborah Fenlon2, Helen Jones1, Claire Foster2, Laura Ashley1,

Kim Chivers Seymour2, Galina Velikova1, Ikumi Okamoto2 and Julia Brown3

1 Psychosocial Oncology and Clinical Practice Research Group, Leeds Institute of Cancer

Studies and Pathology, University of Leeds, Leeds, UK

2Macmillan Survivorship Research Group, Faculty of Health Sciences, University of

Southampton, Southampton, UK

3 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of

Leeds, Leeds, UK

*Corresponding author

Dr Penny Wright,

Psychosocial Oncology and Clinical Practice Research Group, Level three Bexley Wing, St

James’s Institute of Oncology, St James’s University Hospital, Leeds LS9 7TF

[email protected]

Telephone: 00 (44) 113 2068488

Fax: 00 (44) 113 2068512

Keywords

clinical studies, patient recruitment, psychosocial, research nurses, patient accrual, clinical

research network

Word Count: 4,189

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ABSTRACT

Background

Patient recruitment to psychosocial oncology research has increased over the last 10 years

but the majority of studies have been single-site or small-scale. The National Institute for

Health Research (NIHR), Clinical Research Network (CRN) supports NIHR portfolio studies

through provision of research staff to recruit and follow-up patients, but has been little used

by psychosocial researchers. We report the experiences of two psychosocial research teams

who recently used the CRN, to undertake patient recruitment, to inform cancer researchers

of non-clinical trials of an investigational medicinal product (non-CTIMPs) of lessons learned

and to provide recommendations.

Method and outcomes

Patients were successfully recruited to two prospective observational studies: electronic

Patient-reported Outcomes from Cancer Survivors study (ePOCS; n=636) and the

ColoREctal Wellbeing study (CREW; n=1,055). ePOCS secured Comprehensive Local

Research Networks funding to appoint ePOCS-specific study research nurses. CREW

obtained research support through the NIHR Cancer Research Network. Top tips for

establishing and running studies with CRN staff are provided and suggestions given for

advancing multicentre complex non-CTIMPs.

Conclusion

Some challenges were similar to those in delivery of CTIMPs. The pros and cons of being

involved in ePOCS from the research nurse perspective are also described. Overall the

approaches used were successful.

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INTRODUCTION

The importance of psychosocial oncology has been increasingly recognised over recent

decades, leading to the Union International for Cancer Control declaring ‘distress’ the 6th

vital sign in Cancer Care 1. Despite this, psychosocial care has not become fully integrated

into routine cancer care. A number of challenges persist including how psychosocial

oncology is valued as a discipline in its own right, the costs of supportive care, and a lack of

evidence from large-scale well-designed psychosocial trials 2. In the UK cancer research has

been nurtured by the establishment of the National Cancer Research Institute (NCRI:

http://www.ncri.org.uk/ ) Clinical Studies Groups (CSGs). CSGs facilitate and prioritise

studies to address cancer diagnostic-specific questions (i.e. breast, lung) or cross-cutting

issues (i.e. palliative, psychosocial). The National Institute of Health Research (NIHR)

Cancer Research Network (http://www.ncrn.org.uk/ ), established in parallel with the NCRI,

was set up to increase the number of patients participating in high-quality clinical research

studies. The NIHR Cancer Research Network comprises 32 Local Research Networks

across England and provides an infrastructure to support study participation, including

funding for research nurses (RNs). Since 2006 their main focus has been on recruitment to

clinical trials of an investigational medicinal product (CTIMP) randomised controlled trials

(RCT). This has led to increased accrual to RCTs but not at the expense of accrual to

observational studies, may be because some observational studies provide an opportunity

for patients to enrol in RCTs at the same time 3. Timely accrual to both RCTs and

observational studies within the cancer trials portfolio has increased significantly since the

NIHR Cancer Research Network was established, rising from <5% of incidence cases in

2001 to >20% in 2010 3. Although the majority of trials within the portfolio are CTIMPs there

is interest in developing other types of interventional studies 4.The success of the NIHR

Cancer Research Network model for supporting clinical trials in England led to the

establishment of a generic Clinical Research Network (CRN) to provide infrastructure for

other clinical groups. The elements of the NIHR CRN and their inter-relationships and

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acronyms can be confusing. Figure 1 provides an overview and places the national and local

level of networks into context.

The NIHR Cancer Research Network-NCRI CSG model for developing and delivering high-

quality large-scale trials has worked well for clinical trial evaluation of CTIMPs. Some of

these trials have either secondary quality of life outcomes as part of the main study or have

linked sub-studies with primary quality of life outcomes. In the disease site specific CSGs the

majority of members are clinicians. The trials become embedded within clinical practice

across a number of centres where patients are considered for participation at

Multidisciplinary Team (MDT) meetings by clinicians and associated RNs. Across the

country there is a network of clinicians who have duty of care for these patients, who are

research active and who contribute to accrual of portfolio CTIMPs with support mainly from

the NIHR Cancer Research Network.

The model does not work so effectively for psychosocial studies. The Psychosocial

Oncology CSG comprises a varied membership (including health psychology, social work,

nursing, clinical trials), few of whom have responsibility for clinical care. The range of studies

within the psychosocial oncology portfolio is broad, including studies of interventions from

acupuncture to cognitive-behavioural therapy, studies to develop patient decision aids, and

observational studies of patients’ quality of life, health behaviors and care experience. There

is no ready-made clinical infrastructure or experienced study recruitment network to call on

for championing multi-centre psychosocial studies. In addition, psychosocial studies may

require specialist professional input, which is not part of the standard clinical research team,

to deliver an intervention or undertake specialised interviewing or observations. As a result

although there have been some high-quality large-scale psychosocial studies 5-7, many

studies within the growing Psychosocial Oncology CSG portfolio have been single-site or

small-scale and have tended to rely on individual grant-funded appointed research

assistants, rather than using network RNs, for recruitment and follow-up of patients.

Commonly research assistants are psychology graduates looking for research experience to

aid advancement to academic doctoral studies or a clinical psychology career 8. Now there is

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an expectation that some research costs will no longer be met by some grant awarding

bodies. The recently published Department of Health AcoRD document provides the basis

for attributing the costs of health and social care research studies in three categories:

research costs (costs of activities undertaken to answer the research questions), NHS

treatment costs (costs of patient care) and NHS support costs (additional patient care costs

associated with the research)9. If a study is funded by a charity which is a member of the

Association of Medical Research Charities (AMRC) some NHS support costs will be met by

the Department of Health, via the networks, such as the identification of patients suitable to

approach for participation, obtaining consent and additional assessments. In order for the

Psychosocial Oncology CSG to consistently deliver high-quality large-scale observational

studies and trials, use of the networks for recruitment support will have to become standard

practice.

In 2010-2012 two Psychosocial Oncology CSG portfolio observational cohort studies, funded

by Macmillan Cancer Support (AMRC member) and run by University sponsored

researchers, collaborated in two different ways with the networks to support recruitment. In

the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) study the

research team applied for study specific funding for RNs to the generic West Yorkshire

Comprehensive Local Research Network (WYCLRN); in the ColoREctal Wellbeing (CREW)

study the research team asked for expressions of interest for study participation from the

NIHR Cancer Research Networks (Figure 1). Both studies were given research ethics

committee approval (ePOCS (Leeds East 10/H1306/65); CREW (Oxfordshire REC B

10/H0605/31)) and all participants provided written informed consent. We report and

compare the different approaches of ePOCS and CREW with the aim of informing non-

CTIMPs researchers of lessons learned and providing recommendations for future studies.

Figure 1 about here

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THE STUDIES

electronic Patient-reported Outcomes from Cancer Survivors (ePOCS)

http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9403

ePOCS is a secure electronic system for collecting Patient Reported Outcome Measures

(PROMS) via the internet at multiple time-points and linking these data with patients' clinical

data transferred from the electronic patient record (EPR) to the cancer registry and

managing associated patient communications electronically 10. The ePOCS study is a

prospective observational study to test the feasibility of the ePOCS system, by running it for

two years in two NHS Trusts within the Yorkshire Cancer Network (YCN) (the cancer centre

and one cancer unit), and using the Northern and Yorkshire Cancer Registry and Information

Service 11. To test feasibility, all non-metastatic breast, colorectal and prostate cancer

patients attending the two YCN Trusts within six months post-diagnosis needed to be

considered for recruitment (estimated target n=600). Funding was obtained from the

WYCLRN to appoint RNs to be embedded within established cancer site-specific clinical

research teams to recruit expressly to ePOCS over one year. Participants were followed up

by the University of Leeds ePOCS research team.

ColoREctal Wellbeing (CREW)


The CREW study is a prospective observational study involving colorectal cancer patients

following primary surgery using mailed questionnaires. The aim of the study is to establish

the natural history of the recovery of health and well-being following treatment for colorectal

cancer 12. The CREW team needed to work with cancer centres across wide geographic and

socio-demographic areas which could identify, approach and recruit all study-eligible

patients to ensure best representation. To recruit a large number of patients (target n=1,000)

in one year the NIHR Cancer Research Network was approached to support study

recruitment as part of their local portfolio of studies. Sites were selected on their ability to

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recruit in a specified way and to recruit at least 2-3 participants weekly. The RNs recruiting to

CREW were established members of clinical research teams with shared responsibility for

recruitment to CREW and other CTIMPs.

Both studies

The RNs recruiting to these studies operated in much the same way as for CTIMPs in terms

of collaborating and negotiating with MDTs to identify and approach eligible patients. The

RNs informed and consented eligible patients, provided participants with written study

information, completed and returned study documentation to the ePOCS or CREW research

teams and, for the ePOCS study, entered study events onto a clinical trials database within

the EPR 13. Unlike many traditional cancer CTIMPs, the RNs consented and countersigned

the consent forms and, for CREW, in some centres were Principal Investigators. RNs were

not involved with participants after the point of study-consent. Records were kept of the

steps undertaken to encourage support for both studies, and of the outcomes of these. In

ePOCS, following recruitment completion, the RNs were interviewed by the ePOCS senior

RN to find out what it was like to work on ePOCS, how it compared with recruiting to

CTIMPS, and suggestions as to how the RN role might have been improved. Interviews

were audio-recorded and opinions collated.

PROCESSES AND OUTCOMES

How the studies were established within centres and networks

ePOCS

As ePOCS was a University of Leeds sponsored study the first task was to find managers in

each NHS trust to work with the ePOCS research team to make the application for WYCLRN

funding. Any funding approved had to be transacted through an NHS Trust and held by a

Trust budget holder. Initially, an application for responsive funding to the WYCLRN was

made on behalf of ePOCS by the Directorate Manager of non-surgical oncology in the

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Cancer Centre for three whole time equivalent (WTE) RNs for one year. Some months later,

following discussions between the WYCLRN and the cancer unit, additional funding was

requested for one further WTE RN for one year. Following funding approval there were

delays in appointing the RNs (three full-time posts; two part-time posts), with start dates

staggered over four months (Figure 2). Reasons included protracted negotiations with the

cancer centre Trust to find the staff to manage the budget, a lack of understanding by the

ePOCS research team about NHS human resources and financial systems, disjointed

communication with human resources concerning the RN appointment process and being

caught by a 4-month Trust recruitment freeze. In the cancer unit the delay in RN

appointment was due to the later application for CLRN funding. In addition, four of the five

appointed RNs were new to the role, two to the trusts and three to the tumour groups they

were recruiting, thus requiring time for induction. The delays and staggered starts meant the

recruitment period became asynchronous with the grant period and it was necessary to

negotiate a no-cost extension with the funder.

CREW

CREW put out a call to the Cancer Research Networks from the NIHR Cancer Research

Network Coordinating Centre to complete an “Expression of Interest” form.

Sites were selected according to a number of factors including: speed to achieve R&D

approval, ability to recruit good numbers, attendance at a site investigator meeting and

demonstration of close working between the clinical and research team. It was originally

planned to recruit from 24 sites, however, not all sites were able to commence recruitment

as expected or at the anticipated rate. Therefore the number of participating sites was

increased to 30 including further sites being sought from the devolved nations; 13 English, 2

Scottish and 2 Welsh cancer networks were involved.

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Methods employed to support the recruiting centres and CRNs

ePOCS

Interest in ePOCS was generated by consultations with clinicians in the development phase

14. A detailed recruitment process map was iteratively created, and checked with the clinical

teams. As the RNs had staggered starts, their training was largely individual and undertaken

by the ePOCS senior RN. In the month before recruitment started, a half-day site

investigator meeting was held at the cancer unit to inform staff about the study background,

aims and processes (7 attendees). Two meetings were held at the cancer centre, three (11

attendees) and seven (4 attendees) months into recruitment, to review progress and share

practice. In addition to the protocol, a comprehensive study guide and copies of the

recruitment maps were provided for the RNs. Ongoing support to the RNs by the ePOCS

senior RN (and research fellow in her absence) was provided by telephone, email and

weekly visits. A log was kept of study related queries between the ePOCS team and RNs

(initiated by either party). The number of RN queries was highest at the start of recruitment

and fell as the nurses became familiar with study procedures (Figure 2). Eighty-four queries

were raised in total, via phone (n=35), email (n=25) or face-to-face (n=23) (one unspecified).

Queries concerned clarification around eligibility, completion of study events on the EPR,

logistical and administrative tasks and verification of patient email addresses. The ePOCS

team sent emails to the clinical teams (and RNs) following recruitment of every fiftieth

patient, and a congratulatory email on study close. The ePOCS website

(http://www.epocs.leeds.ac.uk/) was updated about once a month with study news including

recruitment figures and information about academic presentations and publications.

CREW

Sites that joined CREW were sent instructions for recruitment and underwent a telephone

conference for study set-up. An initial CREW site investigator meeting was held in the

University of Southampton immediately prior to recruitment commencement to inform those

who would be involved in CREW recruitment about the study and for them to consider how

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to ensure they were able to approach every eligible patient in their centre (29 attendees). A

further site investigator meeting was set up after eight months to update the recruitment

staff, and for those who had not had an opportunity to attend the first meeting (21

attendees). There was a final meeting following recruitment closure in order to celebrate

reaching the accrual target (24 attendees).

All study sites were contacted at least weekly detailing data returns from each site and what

was outstanding. The CREW administrative staff had frequent email and telephone contact

with all sites. Technical queries were passed onto the study PI or clinical co-investigators.

Patient recruitment

ePOCS

Despite having planned a year to setup ePOCS, including time to apply for WYCLRN

funding and appointing RNs, the start date was slightly delayed due to the reasons outlined

above, and recruitment took time to become established in all possible clinics. It was

anticipated there would be cross-cover within the clinical research teams, such that the

ePOCS RNs would contribute to recruiting to other studies, and other RNs would help

support ePOCS. In reality, there was limited cross-cover undertaken for ePOCS by non-

ePOCS RNs. Active recruitment lasted just over ten months, two months longer than

planned, with 636 participants consenting (Figure 2).

Figure 2 about here

CREW

In order to ensure RNs undertook recruitment according to the CREW protocol, the CREW

researchers asked the teams to consider their recruitment processes and to write these into

their ‘Expression of Interest’ to participate in the study. This was also rehearsed at the site

investigator meetings. As R&D approval was protracted in some areas and there were fewer

than anticipated eligible patients in some clinics (as estimated by the sites in their expression

of interest), the overall recruitment rate was slower than expected; recruitment lasted 17

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months, 5 months longer than planned, with 1,055 participants consenting from 29 sites

across 17 cancer networks (including 66 participants from a pilot study) (Figure 2).

Nurse feedback (ePOCS study only)

The three full-time and one of the two part-time ePOCS RNs were interviewed at the end of

the study. In general the nurses gave positive feedback about their involvement in the

ePOCS study, although some downsides were identified (Table 1). Four out of the five

ePOCS RNs have continued to work as RNs, with one moving into the academic

psychosocial research team and the others staying in clinical research teams.

Table 1 about here

Top Tips from lessons learned

Table 2 summarises the top tips learned from these experiences, which would also apply to

CTIMPs.

Table 2 about here

DISCUSSION

Using network resources to underpin recruitment to two prospective observational

psychosocial studies was successful with both studies reaching their recruitment targets.

The process of engaging the research networks and NHS trusts in these recruitment

initiatives was, on occasion, complicated, time-consuming and frustrating for all concerned,

but with perseverance and goodwill from individual champions positive outcomes were

achieved. Using traditional psychosocial recruitment methods, with grant funded RAs, would

have been financially prohibitive for a national multicentre study and impractical, not only

due to the pragmatic and logistical difficulties of finding employers to recruit, and of inducting

new staff, but also due to the difficulty of promoting a psychosocial study, not linked with an

existing randomised CTIMP clinical trial, led by a non-clinical RA in a busy clinical

environment. The feedback from the ePOCS RNs was on the whole positive. The lessons

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learned from ePOCS and CREW should help non-clinically based academic researchers

wishing to undertake psychosocial research in the NHS.

Common to many studies, recruitment took a while to become established and gain

momentum. For the ePOCS study this related in the main to the ePOCS team not being

experienced in navigating NHS human resources systems, NHS processes slowing RN

appointments and, as this was a new scenario for the RNs, a ‘learning’ period was required.

As psychosocial researchers become more experienced and familiar with NHS systems, and

build relationships with NHS colleagues, some of these challenges will be overcome in future

collaborations. Having adequate support from relevant local organisations (R&D, CLRN,

trusts and clinical teams) is key for good representative recruitment. Although in principle

these organisations support all portfolio-adopted studies, non-clinical studies may be seen

as less important than clinical studies. This can lead to a recruitment bias where

psychosocial studies may only have access to patients not involved in clinical trials. In the

ePOCS study this was not a problem as it was accepted by all parties that patients could be

approached about ePOCS even if they were involved in clinical trials. This was more difficult

for the CREW study where in some sites recruitment was squeezed due to competing trials.

To eliminate this problem, where possible, the CREW team chose sites without competing

studies. Uptake of psychosocial studies may be further challenged when the chief and

principal investigators are not embedded in clinical services and are not therefore party to

the traditional medical model of clinical colleagues supporting each other’s studies.

Again, similar to many CTIMPs, one main delay in recruitment to the CREW study was

obtaining R&D approvals. Although research governance application and approval

processes have improved over the last ten years, problems with R&D approvals continue to

cause delays in many studies 15 16. Despite these initial challenges, accrual targets were

met; an important contributory factor may have been the careful attention to planning and

trial management as advocated in one multicentre ovarian cancer screening trial 17.

The RNs who undertook recruitment were part of established clinical research teams whose

main research activities related to cancer CTIMPs, as described by the UK Clinical Research

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Collaboration 18. The classical role of the RN has been defined as covering five main

activities: clinical practice, care coordination and continuity, study management, human

subject protection and contributing to science, with the most important of these reported by

RNs as being clinical practice and care coordination and continuity 19. In ePOCS and CREW,

clinical practice and care coordination and continuity were not part of the RN role. In the

long-term, if RNs were restricted to involvement with simple consenting for non-

interventional studies only, job satisfaction may be compromised, as highlighted in the

ePOCS RN feedback. The CREW approach may provide a more sustainable model, by

providing RNs with a mixed workload and delivering high recruitment figures which reflect

well on the clinical teams and networks. This may have wider benefits by raising awareness

of psychosocial studies at MDT/clinic level within a portfolio of classic medical interventions.

The CREW approach has been effective in the highest recruiting psychosocial portfolio study

to date: the multinational Computerised Adaptive Testing for EORTC-QLQ-C30 (CAT) study

(UKCRN ID 5256). Between April 2010 and March 2011 NIHR CRN RNs recruited 1,603

participants to CAT across the UK (personal communication K. Poole, 2012). CAT has wide

eligibility criteria and requires a single administration of one questionnaire (personal

communication T. Young, 2012). CAT, CREW and ePOCS are all simple observational

studies where no new skills were required for the RNs. ePOCS, CREW and the CAT study

described earlier, accounted for 57% of participants recruited to the Psychosocial Oncology

CSG portfolio between April 2011 and March 2012. It may be a much more difficult task if

there is a need to train RNs in new skills (e.g. for psychosocial intervention studies).

Other recruitment models have also been shown to be successful. In the Northern Cancer

Research Network, Clinical Trial Officer roles have been developed resulting in increased

recruitment to network adopted studies 20. In Southampton, the Macmillan research team

has appointed a Macmillan-funded trials coordinator to support their portfolio studies by

working within the research team to raise awareness of the processes and clinical realities

impacting on non-clinical research.

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Other challenges to psychosocial research may arise as NIHR/Government funders adhere

strictly to AcoRD documents and insist on classifying many of the psychosocial researchers'

tasks as NHS support costs (to be paid for by CLRN and done by RNs in general). As

demonstrated in ePOCS, there is considerable administrative burden in study set-up and

appointing, training and supporting RNs. The appointment of research staff (financially

supported by the funders) is even more important for these studies and possibly requires

more senior researchers with longer contracts. The balance between research and NHS

support staff is different for psychosocial studies and should be recognised by researchers

and funders. In Leeds, following closure of ePOCS, other WYCLRN funded RNs have been

appointed to work within the university psychosocial oncology research group rather than

within clinical research teams. This approach may be particularly useful for more complex

randomised intervention studies which may involve patient tracking, interviewing, delivering

interventions and/or audio-recording consultations. Nurses will bring experience and

knowledge of communicating with patients and carers, and of the patient experience and

treatment pathways, as well as familiarity with medical terminology and the clinical

environment. The psychosocial oncology research team can provide research training and

ongoing support and supervision to RNs appointed in this way. This may help to promote

RNs knowledge of research and thus in some cases nurture their transition from RNs to

individuals pursuing their own research career 18. The disadvantage of this approach is the

partial separation from clinical teams and resultant research governance issues concerning

screening and recruiting patients for trial participation which may require application to the

Care Quality Commission National Information Governance Committee (formally National

Information and Governance Board for Health and Social Care). It also generates problems

with running multicentre psychosocial studies if the RNs are trained and based for more

complex psychosocial studies in one centre only. In addition there may be repercussions for

staff. RNs who have taken on more complex leadership roles in non-traditional clinical trials

have reported challenges with isolation, role conflict, limited co-operation from clinical staff

and difficulties maintaining motivation 21. Appointing RNs rather than research assistants to

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undertake these roles may also undermine opportunities to nurture future academic leads

from psychology and behavioural sciences, who offer an important different perspective from

clinical colleagues, and who in the past have significantly contributed to psychosocial cancer

research.

Quality of life sub-studies in large trials have been very successful in increasing

understanding of patient reported outcomes following specific treatments. However, this

approach is not suitable for many studies where the primary question addresses

psychosocial issues or complex interventions in more depth and in a wider population.

Independent purely psychosocial studies will need to be designed to investigate these

questions. Using the networks to support more complex multi-centred psychosocial

oncology intervention trials will require considerable effort and new ways of working. One

way of taking this forward may be to encourage networks active in psychosocial oncology

recruitment to identify a staff member to act as a network expert with the remit to encourage

development and support of the psychosocial portfolio and liaise with the NCRI Psychosocial

Oncology CSG. There are ten networks which have participated in five or more psychosocial

studies (personal communication K. Poole, 2012). Another way will be for members of the

Psychosocial Oncology CSG to learn from ours and others experiences, work more

collaboratively across the Psychosocial Oncology CSG, with site-specific CSGs and with

clinical partners, harness the resources of the networks and gradually build expertise across

selected networks. By using these approaches psychosocial oncology research in the UK

may increase the numbers of large complex multi-centre intervention studies.

The ePOCS and CREW studies have demonstrated that hard work and collaborative

working to harness network resources to support psychosocial studies does result in positive

outcomes. Many challenges experienced were similar to those found in CTIMPs. To achieve

parity with CTIMPs in front line clinical research, psychosocial researchers will have to

continue investing time and effort to promote the importance and value of psychosocial

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research to clinical colleagues, train network RNs to undertake more complex tasks and

deliver well-designed clinical trials with demonstrable patient benefits.

Acknowledgements

We thank all the patients, staff and the research nurses who supported these studies. We

are grateful to Karen Poole and Teresa Young, Mount Vernon Cancer Centre, UK for

providing us with personal communications and to Karen Poole, National Institute for Health

Research Cancer Research Network (NCRN), and Eileen Loucaides, NCRI Clinical Studies

Groups Secretariat, for their feedback on this article.

Funding

This research was funded by Macmillan Cancer Support. They had no involvement in the

study design; in the collection, analysis and interpretation data; in the writing of the report;

and in the decision to submit the paper for publication.

Licence for Publication

The Corresponding Author has the right to grant on behalf of all authors and does grant on

behalf of all authors, an exclusive licence (or non exclusive for government employees) on a

worldwide basis to the BMJ Publishing Group Ltd to permit this article (if accepted) to be

published in BMJ Supportive and Palliative Care and any other BMJPGL products and

sublicences such use and exploit all subsidiary rights, as set out in our licence

(http://group.bmj.com/products/journals/instructions-for-authors/licence-forms).

Competing Interest

Competing Interest: None declared.

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80.

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2. Bultz BD, Johansen C. Screening for Distress, the 6th Vital Sign: where are we, and

where are we going? Psychooncology 2011;20:569-71.

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UK. Ann Oncol 2011;22:29-35.

4. Stead M, Cameron D, Lester N, et al. Strengthening clinical cancer research in the United

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5. Fallowfield L, Jenkins V, Farewell V, et al. Efficacy of a Cancer Research UK

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6. Velikova G, Booth L, Smith AB, et al. Measuring quality of life in routine oncology

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7. Armes J, Crowe M, Colbourne L, et al. Patients' supportive care needs beyond the end of

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8. British Psychological Society. Becoming a clinical psychologist. 2012; Available from:

http://www.bps.org.uk/careers-education-training/how-become-psychologist/types-

psychologists/becoming-clinical-psychologis . (Accessed 31st October 2012).

9. Department of Health Research and Development Directorate. Attributing the costs of

health and social care Research & Development (AcoRD). Department of Health. London:

Crown, 2012.

10. Ashley L, Jones H, Thomas J, et al. Integrating cancer survivors' experiences into UK

cancer registries: design and development of the ePOCS system (electronic Patient-reported

Outcomes from Cancer Survivors). Br J Cancer 2011;105(S1):S74-S81.

11. Ashley L, Jones H, Forman D, et al. Feasibility test of a UK-scalable electronic system

for regular collection of patient-reported outcome measures and linkage with clinical cancer

registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS)

system. BMC Med Inform Decis Mak 2011;11:66.

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12. Fenlon D, Richardson A, Addington-Hall J, et al. A cohort study of the recovery of health

and wellbeing following colorectal cancer (CREW study): protocol paper. BMC Health Serv

Res 2012;12:90.

13. Newsham AC, Johnston C, Hall G, et al. Development of an advanced database for

clinical trials integrated with an electronic patient record system. Comput Biol Med

2011;41:575-86.

14. Ashley L, Jones H, Velikova G, et al. Cancer patients’ and clinicians’ opinions on the

best time in secondary care to approach patients for recruitment to longitudinal

questionnaire-based research. Support Care Cancer: 2012;20:3365-3372.

15. Chester P, Khunti K. Approval times for a multi-centre diabetes study in UK primary

care. Diabet Med. 2012;29:554-55.

16. Fudge N, Redfern J, Wolfe C, et al. Streamlined research governance: are we there yet?

BMJ. 2010;341.

17. Menon U, Gentry-Maharaj A, Ryan A, et al. Recruitment to multicentre trials—lessons

from UKCTOCS: descriptive study. BMJ 2008;337.

18. UKCRC Subcommittee for Nurses in Clinical Research (Workforce). Developing the

best research professionals - Qualified graduate nurses: recommendations for preparing and

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19. Bevans M, Hastings C, Wehrlen L, et al. Defining Clinical Research Nursing Practice:

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20. Cox K, Avis M, Wilson E, et al. An evaluation of the introduction of Clinical Trial Officer

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21. Spilsbury K, Petherick E, Cullum N, et al. The role and potential contribution of clinical

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Table 1 ePOCS research nurse feedback: top ten PROs and CONs

Pros Cons

1. The RNs found ePOCS an interesting

study.

2. ePOCS RNs were the experts in the

study at MDT meeting.

3. Broad eligibility criteria meant large

numbers of patients could be

approached and recruited.

4. Recruitment criteria allowed a varied time

of approach post-diagnosis.

5. ePOCS required no additional hospital

visits.

6. RNs found ePOCS easier to explain to

patients than CTIMPs.

7. The ePOCS study was easy for patients

to understand.

8. Patients were interested in ePOCS

9. It was easy for patients to make a

decision about joining ePOCS.

10. Immediate patient consent was allowed.

1. The ePOCS RNs had to put in a lot of

effort to get doctors on board.

2. As there was a broad eligibility criteria

there were many clinics to cover.

3. The ePOCS study was not a high

priority in clinics.

4. Usually doctors needed reminding to

mention to patients about the ePOCS

study.

5. Cover for ePOCS RN absence was a

problem.

6. ePOCS RNs found it hard to support

other portfolio studies as their time

was taken up with ePOCS.

7. Obtaining patient notes to file ePOCS

consent forms was an issue.

8. No follow-up with patients was a

downside.

9. Being involved in ePOCS only could

become dissatisfying over time.

10. As with other studies, ePOCS RNs

felt under pressure to recruit which

was not so good when recruitment is

not going well.

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Table 2 Top tips for using the Clinical Research Network to support patient recruitment to psychosocial cancer research

1. Allow more time than you expect for study set-up.

2. Find local NHS and network champions (clinical and management) with whom to

collaborate.

3. For a multi-centre study consider the challenges of ensuring your study is included

into the local portfolio of a network and appropriately supported by clinical

research network staff.

4. If conducting a multi-centre study liaise with national coordinating centre to

discuss feasibility and deliverability to develop achievable milestones.

5. For limited site studies consider whether it would be more efficient to seek

dedicated clinical research staff (either from existing establishments or through

applying for time-limited funding through NIHR Comprehensive Local Research

Networks).

6. Work closely with local R&D managers and invite them to site investigator

meetings where possible.

7. Give as much information as possible in advance so that local teams can make

realistic assessments of what is achievable, especially for UK-wide trials.

8. Provide clear and comprehensive resources for the RNs for their own use, and for

them to educate clinical and MDT colleagues.

9. Be flexible to accommodate local variation; one size does not fit all. Work with

local RNs and clinical teams to establish best recruitment methods for specific

clinical practices.

10. Invest time in training RNs to undertake recruitment, especially if they are new to

post.

11. Respond quickly to RN queries and ensure you have senior research team

members available to answer complex questions.

12. Create good relationships with clinical staff by developing open communication

using a variety of methods (email, fax, face-to-face meetings, phone, website).

13. Regularly provide feedback on local and overall recruitment to networks, clinical

teams and RNs. Arrange study events/workshops for recruiting teams. Celebrate

success.

14. Keep the funder up to date with progress and challenges.

15. Thank all involved and acknowledge them in presentations and publications.

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Overview of the NIHR Clinical Research Network (England) with an emphasis on the Yorkshire Cancer Research Network

202x239mm (300 x 300 DPI)

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ePOCS and CREW recruitment over time

202x251mm (300 x 300 DPI)

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Using the Clinical Research Network for psychosocial research:

lessons learned from two observational studies

Penny Wright*1, Deborah Fenlon2, Helen Jones1, Claire Foster2, Laura Ashley1,

Kim Chivers Seymour2, Galina Velikova1, Ikumi Okamoto2 and Julia Brown3

1 Psychosocial Oncology and Clinical Practice Research Group, Leeds Institute of Cancer

Studies and Pathology, University of Leeds, Leeds, UK

2Macmillan Survivorship Research Group, Faculty of Health Sciences, University of

Southampton, Southampton, UK

3 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of

Leeds, Leeds, UK

*Corresponding author

Dr Penny Wright,

Psychosocial Oncology and Clinical Practice Research Group, Level three Bexley Wing, St

James’s Institute of Oncology, St James’s University Hospital, Leeds LS9 7TF

[email protected]

Telephone: 00 (44) 113 2068488

Fax: 00 (44) 113 2068512

Keywords

clinical studies, patient recruitment, psychosocial, research nurses, patient accrual, clinical

research network

Word Count: 4,078

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ABSTRACT

Background

Patient recruitment to psychosocial oncology research has increased over the last 10 years

but the majority of studies have been single-site or small-scale. The National Institute for

Health Research (NIHR), Clinical Research Network (CRN) supports NIHR portfolio studies

through provision of research staff to recruit and follow-up patients, but has been little used

by psychosocial researchers. We report the experiences of two psychosocial research teams

who recently used the CRN, to undertake patient recruitment, to inform cancer researchers

of non-clinical trials of an investigational medicinal product (non-CTIMPs) of lessons learned

and to provide recommendations.

Method and outcomes

Patients were successfully recruited to two prospective observational studies: electronic

Patient-reported Outcomes from Cancer Survivors study (ePOCS; n=636) and the

ColoREctal Wellbeing study (CREW; n=1,055). ePOCS secured Comprehensive Local

Research Networks funding to appoint ePOCS-specific study research nurses. CREW

obtained research support through the NIHR Cancer Research Network. Top tips for

establishing and running studies with CRN staff are provided and suggestions given for

advancing multicentre complex non-CTIMPs.

Conclusion

Some challenges were similar to those in delivery of CTIMPs. The pros and cons of being

involved in ePOCS from the research nurse perspective are also described. Overall the

approaches used were successful.

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INTRODUCTION

The importance of psychosocial oncology has been increasingly recognised over recent

decades, leading to the Union International for Cancer Control declaring ‘distress’ the 6th

vital sign in Cancer Care 1. Despite this, psychosocial care has not become fully integrated

into routine cancer care. A number of challenges persist including how psychosocial

oncology is valued as a discipline in its own right, the costs of supportive care, and a lack of

evidence from large-scale well-designed psychosocial trials 2. In the UK cancer research has

been nurtured by the establishment of the National Cancer Research Institute (NCRI:

http://www.ncri.org.uk/ ) Clinical Studies Groups (CSGs). CSGs facilitate and prioritise

studies to address cancer diagnostic-specific questions (i.e. breast, lung) or cross-cutting

issues (i.e. palliative, psychosocial). The National Institute of Health Research (NIHR)

Cancer Research Network (http://www.ncrn.org.uk/ ), established in parallel with the NCRI,

was set up to increase the number of patients participating in high-quality clinical research

studies. The NIHR Cancer Research Network comprises 32 Local Research Networks

across England and provides an infrastructure to support study participation, including

funding for research nurses (RNs). Since 2006 their main focus has been on recruitment to

clinical trials of an investigational medicinal product (CTIMP) randomised controlled trials

(RCT). This has led to increased accrual to RCTs but not at the expense of accrual to

observational studies, may be because some observational studies provide an opportunity

for patients to enrol in RCTs at the same time 3. Timely accrual to both randomised

controlled trials (RCTs) and observational studies within the cancer trials portfolio has

increased significantly since the NIHR Cancer Research Network was established, rising

from <5% of incidence cases in 2001 to >20% in 2010 3. Although the majority of trials

within the portfolio are clinical trials of an investigational medicinal product (CTIMPs) there is

interest in developing other types of interventional studies 4.The success of the NIHR Cancer

Research Network model for supporting clinical trials in England led to the establishment of

a generic Clinical Research Network (CRN) to provide infrastructure for other clinical groups.

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The elements of the NIHR CRN and their inter-relationships and acronyms can be confusing.

Figure 1 provides an overview and places the national and local level of networks into

context.

The NIHR Cancer Research Network-NCRI CSG model for developing and delivering high-

quality large-scale trials has worked well for clinical trial evaluation of CTIMPs. Some of

these trials have either secondary quality of life outcomes as part of the main study or have

linked sub-studies with primary quality of life outcomes. In the disease site specific CSGs the

majority of members are clinicians. The trials become embedded within clinical practice

across a number of centres where patients are considered for participation at

Multidisciplinary Team (MDT) meetings by clinicians and associated RNs. Across the

country there is a network of clinicians who have duty of care for these patients, who are

research active and who contribute to accrual of portfolio CTIMPs with support mainly from

the NIHR Cancer Research Network.

The model does not work so effectively for psychosocial studies. The Psychosocial

Oncology CSG comprises a varied membership (including health psychology, social work,

nursing, clinical trials), few of whom have responsibility for clinical care. The range of studies

within the psychosocial oncology portfolio is broad, including studies of interventions from

acupuncture to cognitive-behavioural therapy, studies to develop patient decision aids, and

observational studies of patients’ quality of life, health behaviors and care experience. There

is no ready-made clinical infrastructure or experienced study recruitment network to call on

for championing multi-centre psychosocial studies. In addition, psychosocial studies may

require specialist professional input, which is not part of the standard clinical research team,

to deliver an intervention or undertake specialised interviewing or observations. As a result

although there have been some high-quality large-scale psychosocial studies 5-7, many

studies within the growing Psychosocial Oncology CSG portfolio have been single-site or

small-scale and have tended to rely on individual grant-funded appointed research

assistants, rather than using network RNs, for recruitment and follow-up of patients.

Commonly research assistants are psychology graduates looking for research experience to

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aid advancement to academic doctoral studies or a clinical psychology career 58. Now there

is an expectation that some research costs will no longer be met by some grant awarding

bodies. The recently published Department of Health AcoRD document provides the basis

for attributing the costs of health and social care research studies in three categories:

research costs (costs of activities undertaken to answer the research questions), NHS

treatment costs (costs of patient care) and NHS support costs (additional patient care costs

associated with the research) 69. If a study is funded by a charity which is a member of the

Association of Medical Research Charities (AMRC) some NHS support costs will be met by

the Department of Health, via the networks, such as the identification of patients suitable to

approach for participation, obtaining consent and additional assessments. In order for the

Psychosocial Oncology CSG to consistently deliver high-quality large-scale observational

studies and trials, use of the networks for recruitment support will have to become standard

practice.

In 2010-2012 two Psychosocial Oncology CSG portfolio observational cohort studies, funded

by Macmillan Cancer Support (AMRC member) and run by University sponsored

researchers, collaborated in two different ways with the networks to support recruitment. In

the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) study the

research team applied for study specific funding for RNs to the generic West Yorkshire

Comprehensive Local Research Network (WYCLRN); in the ColoREctal Wellbeing (CREW)

study the research team asked for expressions of interest for study participation from the

NIHR Cancer Research Networks (Figure 1). Both studies were given research ethics

committee approval (ePOCS (Leeds East 10/H1306/65); CREW (Oxfordshire REC B

10/H0605/31)) and all participants provided written informed consent. We report and

compare the different approaches of ePOCS and CREW with the aim of informing non-

CTIMPs researchers of lessons learned and providing recommendations for future studies.

Figure 1 about here

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THE STUDIES

electronic Patient-reported Outcomes from Cancer Survivors (ePOCS)


ePOCS is a secure electronic system for collecting Patient Reported Outcome Measures

(PROMS) via the internet at multiple time-points and linking these data with patients' clinical

data transferred from the electronic patient record (EPR) to the cancer registry and

managing associated patient communications electronically 710. The ePOCS study is a

prospective observational study to test the feasibility of the ePOCS system, by running it for

two years in two NHS Trusts within the Yorkshire Cancer Network (YCN) (the cancer centre

and one cancer unit), and using the Northern and Yorkshire Cancer Registry and Information

Service 811. To test feasibility, all non-metastatic breast, colorectal and prostate cancer

patients attending the two YCN Trusts within six months post-diagnosis needed to be

considered for recruitment (estimated target n=600). Funding was obtained from the

WYCLRN to appoint RNs to be embedded within established cancer site-specific clinical

research teams to recruit expressly to ePOCS over one year. Participants were followed up

by the University of Leeds ePOCS research team.

ColoREctal Wellbeing (CREW)


The CREW study is a prospective observational study involving colorectal cancer patients

following primary surgery using mailed questionnaires. The aim of the study is to establish

the natural history of the recovery of health and well-being following treatment for colorectal

cancer 912. The CREW team needed to work with cancer centres across wide geographic

and socio-demographic areas which could identify, approach and recruit all study-eligible

patients to ensure best representation. To recruit a large number of patients (target n=1,000)

in one year the NIHR Cancer Research Network was approached to support study

recruitment as part of their local portfolio of studies. Sites were selected on their ability to

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recruit in a specified way and to recruit at least 2-3 participants weekly. The RNs recruiting to

CREW were established members of clinical research teams with shared responsibility for

recruitment to CREW and other CTIMPs.

Both studies

The RNs recruiting to these studies operated in much the same way as for CTIMPs in terms

of collaborating and negotiating with MDTs to identify and approach eligible patients. The

RNs informed and consented eligible patients, provided participants with written study

information, completed and returned study documentation to the ePOCS or CREW research

teams and, for the ePOCS study, entered study events onto a clinical trials database within

the EPR 1013. Unlike many traditional cancer CTIMPs, the RNs consented and countersigned

the consent forms and, for CREW, in some centres were Principal Investigators. RNs were

not involved with participants after the point of study-consent. Records were kept of the

steps undertaken to encourage support for both studies, and of the outcomes of these. In

ePOCS, following recruitment completion, the RNs were interviewed by the ePOCS senior

RN to find out what it was like to work on ePOCS, how it compared with recruiting to

CTIMPS, and suggestions as to how the RN role might have been improved. Interviews

were audio-recorded and opinions collated.

PROCESSES AND OUTCOMES

How the studies were established within centres and networks

ePOCS

As ePOCS was a University of Leeds sponsored study the first task was to find managers in

each NHS trust to work with the ePOCS research team to make the application for WYCLRN

funding. Any funding approved had to be transacted through an NHS Trust and held by a

Trust budget holder. Initially, an application for responsive funding to the WYCLRN was

made on behalf of ePOCS by the Directorate Manager of non-surgical oncology in the

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Cancer Centre for three whole time equivalent (WTE) RNs for one year. Some months later,

following discussions between the WYCLRN and the cancer unit, additional funding was

requested for one further WTE RN for one year. Following funding approval there were

delays in appointing the RNs (three full-time posts; two part-time posts), with start dates

staggered over four months (Figure 2). Reasons included protracted negotiations with the

cancer centre Trust to find the staff to manage the budget, a lack of understanding by the

ePOCS research team about NHS human resources and financial systems, disjointed

communication with human resources concerning the RN appointment process and being

caught by a 4-month Trust recruitment freeze. In the cancer unit the delay in RN

appointment was due to the later application for CLRN funding. In addition, four of the five

appointed RNs were new to the role, two to the trusts and three to the tumour groups they

were recruiting, thus requiring time for induction. The delays and staggered starts meant the

recruitment period became asynchronous with the grant period and it was necessary to

negotiate a no-cost extension with the funder.

CREW

CREW put out a call to the Cancer Research Networks from the NIHR Cancer Research

Network Coordinating Centre to complete an “Expression of Interest” form.

Sites were selected according to a number of factors including: speed to achieve R&D

approval, ability to recruit good numbers, attendance at a site investigator meeting and

demonstration of close working between the clinical and research team. It was originally

planned to recruit from 24 sites, however, not all sites were able to commence recruitment

as expected or at the anticipated rate. Therefore the number of participating sites was

increased to 30 including further sites being sought from the devolved nations; 13 English, 2

Scottish and 2 Welsh cancer networks were involved.

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Methods employed to support the recruiting centres and CRNs

ePOCS

Interest in ePOCS was generated by consultations with clinicians in the development phase

1114. A detailed recruitment process map was iteratively created, and checked with the

clinical teams. As the RNs had staggered starts, their training was largely individual and

undertaken by the ePOCS senior RN. In the month before recruitment started, a half-day site

investigator meeting was held at the cancer unit to inform staff about the study background,

aims and processes (7 attendees). Two meetings were held at the cancer centre, three (11

attendees) and seven (4 attendees) months into recruitment, to review progress and share

practice. In addition to the protocol, a comprehensive study guide and copies of the

recruitment maps were provided for the RNs. Ongoing support to the RNs by the ePOCS

senior RN (and research fellow in her absence) was provided by telephone, email and

weekly visits. A log was kept of study related queries between the ePOCS team and RNs

(initiated by either party). The number of RN queries was highest at the start of recruitment

and fell as the nurses became familiar with study procedures (Figure 2). Eighty-four queries

were raised in total, via phone (n=35), email (n=25) or face-to-face (n=23) (one unspecified).

Queries concerned clarification around eligibility, completion of study events on the EPR,

logistical and administrative tasks and verification of patient email addresses. The ePOCS

team sent emails to the clinical teams (and RNs) following recruitment of every fiftieth

patient, and a congratulatory email on study close. The ePOCS website

(http://www.epocs.leeds.ac.uk/) was updated about once a month with study news including

recruitment figures and information about academic presentations and publications.

CREW

Sites that joined CREW were sent instructions for recruitment and underwent a telephone

conference for study set-up. An initial CREW site investigator meeting was held in the

University of Southampton immediately prior to recruitment commencement to inform those

who would be involved in CREW recruitment about the study and for them to consider how

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to ensure they were able to approach every eligible patient in their centre (29 attendees). A

further site investigator meeting was set up after eight months to update the recruitment

staff, and for those who had not had an opportunity to attend the first meeting (21

attendees). There was a final meeting following recruitment closure in order to celebrate

reaching the accrual target (24 attendees).

All study sites were contacted at least weekly detailing data returns from each site and what

was outstanding. The CREW administrative staff had frequent email and telephone contact

with all sites. Technical queries were passed onto the study PI or clinical co-investigators.

Patient recruitment

ePOCS

Despite having planned a year to setup ePOCS, including time to apply for WYCLRN

funding and appointing RNs, the start date was slightly delayed due to the reasons outlined

above, and recruitment took time to become established in all possible clinics. It was

anticipated there would be cross-cover within the clinical research teams, such that the

ePOCS RNs would contribute to recruiting to other studies, and other RNs would help

support ePOCS. In reality, there was limited cross-cover undertaken for ePOCS by non-

ePOCS RNs. Active recruitment lasted just over ten months, two months longer than

planned, with 636 participants consenting (Figure 2).

Figure 2 about here

CREW

In order to ensure RNs undertook recruitment according to the CREW protocol, the CREW

researchers asked the teams to consider their recruitment processes and to write these into

their ‘Expression of Interest’ to participate in the study. This was also rehearsed at the site

investigator meetings. As R&D approval was protracted in some areas and there were fewer

than anticipated eligible patients in some clinics (as estimated by the sites in their expression

of interest), the overall recruitment rate was slower than expected; recruitment lasted 17

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months, 5 months longer than planned, with 1,055 participants consenting from 29 sites

across 17 cancer networks (including 66 participants from a pilot study) (Figure 2).

Nurse feedback (ePOCS study only)

The three full-time and one of the two part-time ePOCS RNs were interviewed at the end of

the study. In general the nurses gave positive feedback about their involvement in the

ePOCS study, although some downsides were identified (Table 1). Four out of the five

ePOCS RNs have continued to work as RNs with one moving into the academic

psychosocial research team and the others staying in clinical research teams.

Table 1 about here

Top Tips from lessons learned

Table 2 summarises the top tips learned from these experiences, which would also apply to

CTIMPs.

Table 2 about here

DISCUSSION

Using network resources to underpin recruitment to two prospective observational

psychosocial studies was successful with both studies reaching their recruitment targets.

The process of engaging the research networks and NHS trusts in these recruitment

initiatives was, on occasion, complicated, time-consuming and frustrating for all concerned,

but with perseverance and goodwill from individual champions positive outcomes were

achieved. Using traditional psychosocial recruitment methods, with grant funded RAs, would

have been financially prohibitive for a national multicentre study and impractical, not only

due to the pragmatic and logistical difficulties of finding employers to recruit, and of inducting

new staff, but also due to the difficulty of promoting the a psychosocial studies study, not

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linked with an existing randomised CTIMP clinical trial, led by a non-clinical RA in a busy

clinical environment. alongside clinical trials. The feedback from the ePOCS RNs was on

the whole positive. The lessons learned from ePOCS and CREW should help non-clinically

based academic researchers wishing to undertake psychosocial research in the NHS.

Common to many studies, recruitment took a while to become established and gain

momentum. For the ePOCS study this related in the main to the ePOCS team not being

experienced in navigating NHS human resources systems, NHS processes slowing RN

appointments and, as this was a new scenario for the RNs, a ‘learning’ period was required.

As psychosocial researchers become more experienced and familiar with NHS systems, and

build relationships with NHS colleagues, some of these challenges will be overcome in future

collaborations. Having adequate support from relevant local organisations (R&D, CLRN,

trusts and clinical teams) is key for good representative recruitment. Although in principle

these organisations support all portfolio-adopted studies, non-clinical studies may be seen

as less important than clinical studies. This can lead to a recruitment bias where

psychosocial studies may only have access to patients not involved in clinical trials. In the

ePOCS study this was not a problem as it was accepted by all parties that patients could be

approached about ePOCS even if they were involved in clinical trials. This was more difficult

for the CREW study where in some sites recruitment was squeezed due to competing trials.

To eliminate this problem, where possible, the CREW team chose sites without competing

studies. Uptake of psychosocial studies may be further challenged when the chief and

principal investigators are not embedded in clinical services and are not therefore party to

the traditional medical model of clinical colleagues supporting each other’s studies.

Again, similar to many CTIMPs, one main delay in recruitment to the CREW study was

obtaining R&D approvals. Although research governance application and approval

processes have improved over the last ten years, problems with R&D approvals continue to

cause delays in many studies 12 1315 16. Despite these initial challenges, accrual targets were

met; an important contributory factor may have been the careful attention to planning and

trial management as advocated in one multicentre ovarian cancer screening trial 1417.

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The RNs who undertook recruitment were part of established clinical research teams whose

main research activities related to cancer CTIMPs, as described by the UK Clinical Research

Collaboration 1518. The classical role of the RN has been defined as covering five main

activities: clinical practice, care coordination and continuity, study management, human

subject protection and contributing to science, with the most important of these reported by

RNs as being clinical practice and care coordination and continuity 1619. In ePOCS and

CREW, clinical practice and care coordination and continuity were not part of the RN role. In

the long-term, if RNs were restricted to involvement with simple consenting for non-

interventional studies only, job satisfaction may be compromised, as highlighted in the

ePOCS RN feedback. The CREW approach may provide a more sustainable model, by

providing RNs with a mixed workload and delivering high recruitment figures which reflect

well on the clinical teams and networks. This may have wider benefits by raising awareness

of psychosocial studies at MDT/clinic level within a portfolio of classic medical interventions.

The CREW approach has been effective in the highest recruiting psychosocial portfolio study

to date: the multinational Computerised Adaptive Testing for EORTC-QLQ-C30 (CAT) study

(UKCRN ID 5256). Between April 2010 and March 2011 NIHR CRN RNs recruited 1,603

participants to CAT across the UK (personal communication K. Poole, 2012). CAT has wide

eligibility criteria and requires a single administration of one questionnaire (personal

communication T. Young, 2012). CAT, CREW and ePOCS are all simple observational

studies where no new skills were required for the RNs. ePOCS, CREW and the CAT study

described earlier, accounted for 57% of participants recruited to the Psychosocial Oncology

CSG portfolio between April 2011 and March 2012. It may be a much more difficult task if

there is a need to train RNs in new skills (e.g. for psychosocial intervention studies).

Other recruitment models have also been shown to be successful. In the Northern Cancer

Research Network, Clinical Trial Officer roles have been developed resulting in increased

recruitment to network adopted studies 1720. In Southampton, the Macmillan research team

has appointed a Macmillan-funded trials coordinator to support their portfolio studies by

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working within the research team to raise awareness of the processes and clinical realities

impacting on non-clinical research.

Other challenges to psychosocial research may arise as NIHR/Government funders adhere

strictly to AcoRD documents and insist on classifying many of the psychosocial researchers'

tasks as NHS support costs (to be paid for by CLRN and done by RNs in general). As

demonstrated in ePOCS, there is considerable administrative burden in study set-up and

appointing, training and supporting RNs. The appointment of research staff (financially

supported by the funders) is even more important for these studies and possibly requires

more senior researchers with longer contracts. The balance between research and NHS

support staff is different for psychosocial studies and should be recognised by researchers

and funders. In Leeds, following closure of ePOCS, other WYCLRN funded RNs have been

appointed to work within the university psychosocial oncology research group rather than

within clinical research teams. This approach may be particularly useful for more complex

randomised intervention studies which may involve patient tracking, interviewing, delivering

interventions and/or audio-recording consultations. Nurses will bring experience and

knowledge of communicating with patients and carers, and of the patient experience and

treatment pathways, as well as familiarity with medical terminology and the clinical

environment. The psychosocial oncology research team can provide research training and

ongoing support and supervision to RNs appointed in this way. This may help to promote

RNs knowledge of research and thus in some cases nurture their transition from RNs to

individuals pursuing their own research career 1518. The disadvantage of this approach is the

partial separation from clinical teams and resultant research governance issues concerning

screening and recruiting patients for trial participation which may require application to the

Care Quality Commission National Information Governance Committee (formally National

Information and Governance Board for Health and Social Care). It also generates problems

with running multicentre psychosocial studies if the RNs are trained and based for more

complex psychosocial studies in one centre only. In addition there may be repercussions for

staff. RNs who have taken on more complex leadership roles in non-traditional clinical trials

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have reported challenges with isolation, role conflict, limited co-operation from clinical staff

and difficulties maintaining motivation 1821. Appointing RNs rather than research assistants to

undertake these roles may also undermine opportunities to nurture future academic leads

from psychology and behavioural sciences, who offer an important different perspective from

clinical colleagues, and who in the past have significantly contributed to psychosocial cancer

research.

Quality of life sub-studies in large trials have been very successful in increasing

understanding of patient reported outcomes following specific treatments. However, this

approach is not suitable for many studies where the primary question addresses

psychosocial issues or complex interventions in more depth and in a wider population.

Independent purely psychosocial studies will need to be designed to investigate these

questions. Using the networks to support more complex multi-centred psychosocial

oncology intervention trials will require considerable effort and new ways of working. One

way of taking this forward may be to encourage networks active in psychosocial oncology

recruitment to identify a staff member to act as a network expert with the remit to encourage

development and support of the psychosocial portfolio and liaise with the NCRI Psychosocial

Oncology CSG. There are ten networks which have participated in five or more psychosocial

studies (personal communication K. Poole, 2012). Another way will be for members of the

Psychosocial Oncology CSG to learn from ours and others experiences, work more

collaboratively across the Psychosocial Oncology CSG, with site-specific CSGs and with

clinical partners, harness the resources of the networks and gradually build expertise across

selected networks. By using these approaches psychosocial oncology research in the UK

may increase the numbers of large complex multi-centre intervention studies.

The ePOCS and CREW studies have demonstrated that hard work and collaborative

working to harness network resources to support psychosocial studies does result in positive

outcomes. Many challenges experienced were similar to those found in CTIMPs. To achieve

parity with CTIMPs in front line clinical research, psychosocial researchers will have to

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continue investing time and effort to promote the importance and value of psychosocial

research to clinical colleagues, train network RNs to undertake more complex tasks and

deliver well-designed clinical trials with demonstrable patient benefits.

Acknowledgements

We thank all the patients, staff, the research nurses and the research networks who

supported these studies We are grateful to Karen Poole and Teresa Young, Mount Vernon

Cancer Centre, UK for providing us with personal communications and to Karen Poole,

National Institute for Health Research Cancer Research Network (NCRN), and Eileen

Loucaides, NCRI Clinical Studies Groups Secretariat, for their feedback on this article.

Funding

This research was funded by Macmillan Cancer Support. They had no involvement in the

study design; in the collection, analysis and interpretation data; in the writing of the report;

and in the decision to submit the paper for publication.

Licence for Publication

The Corresponding Author has the right to grant on behalf of all authors and does grant on

behalf of all authors, an exclusive licence (or non exclusive for government employees) on a

worldwide basis to the BMJ Publishing Group Ltd to permit this article (if accepted) to be

published in BMJ Supportive and Palliative Care and any other BMJPGL products and

sublicences such use and exploit all subsidiary rights, as set out in our licence

(http://group.bmj.com/products/journals/instructions-for-authors/licence-forms).

Competing Interest

Competing Interest: None declared.

Competing interests

None.

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Using the Clinical Research Network for psychosocial research: lessons learned from two observational studies

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