International psychometric validation of an EORTC quality of life module measuring cancer related fatigue (EORTC QLQ-FA12) Joachim Weis 1 , Krzysztof A.Tomaszewski 2 , Eva Hammerlid 3 , Juan Ignacio Arraras 4 , Thierry Conroy 5 , Anne Lanceley 6 , Heike Schmidt 7 , Susanne Singer 8 ,Monica Pinto 9 , Mohamed Alm El- Din 10 , Inge Compter 11 , Bernhard Holzner 12 , Dirk Hofmeister 13 , Wei-Chu Chie 14 , Marek Czeladzki 15 , Amelie Harle 16 , Louise Jones 17 , Sabrina Ritter 18 , Markus Wirtz 19 , Hans-Henning Flechtner 20 , Andrew Bottomley 21 On Behalf of the EORTC Quality of Life Group 1 Tumor Biology Centre University Clinic Centre Freiburg, Freiburg, Germany 2 Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland 3 Department of Otolaryngology Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden 4 Oncology departments. Complejo Hospitalario de Navarra. Pamplona. Spain 5 Department of Medical Oncology, Lorraine Cancer Institute, Nancy, Nancy, France 6 Institute for Women’s Health, University College, London, UK 7 Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle, Halle, Germany 8 Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre Mainz, Mainz, Germany 9 Rehabilitation Unit, Department of Health Policy, Farmacy and Quality of Life, Istituto Nazionale Tumori "Fondazione Giovanni Pascale"- IRCCS - Naples, Italy. 10 Department of Clinical Oncology, Tanta Faculty of Medicine, Egypt 11 Department of Radiation Oncology (MAASTRO), GROW (School for Oncology & Developmental Biology), University of Maastricht Medical Center, Maastricht, The Netherlands 12 Department of Psychiatry and Psychotherapy, Medical University of Innsbruck, Austria 13 Department of Medical Psychology and Medical Sociology, University of Leipzig, Germany 14 Department of Family Medicine, National Taiwan University, Taiwan 15 Research and Development Office, Southern Health NHS Foundation Trust, Southampton, UK 16 Medical Oncology Department, The Christie NHS Foundation Trust, Manchester, UK. 17 HPB Services Directorate of Surgery, University Hospital Aintree, Liverpool, UK 18 Institute of Research in Rehabilitation Medicine at Ulm University, Ulm, Germany 19 Department of Research Methods, University of Education, Freiburg, Germany 20 Department of Paediatric Psychiatry, University of Magdeburg, Magdeburg, Germany 21 Quality of Life Department, EORTC Headquarters, Brussels, Belgium Address of correspondence: Joachim Weis Prof. PhD. University Clinic Centre Freiburg Tumor Biology Clinic Department of Psycho-Oncology Breisacher Str. 117 79106 Freiburg Phone 0049-(0)761-206-2220
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International psychometric validation of an EORTC quality of life module measuring cancer related fatigue (EORTC QLQ-FA12) Joachim Weis1, Krzysztof A.Tomaszewski2, Eva Hammerlid3, Juan Ignacio Arraras4, Thierry
Din10, Inge Compter11, Bernhard Holzner12, Dirk Hofmeister13, Wei-Chu Chie14, Marek
Czeladzki15, Amelie Harle16, Louise Jones17, Sabrina Ritter18, Markus Wirtz19, Hans-Henning
Flechtner20, Andrew Bottomley21
On Behalf of the EORTC Quality of Life Group
1 Tumor Biology Centre University Clinic Centre Freiburg, Freiburg, Germany 2 Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland 3 Department of Otolaryngology Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden 4 Oncology departments. Complejo Hospitalario de Navarra. Pamplona. Spain 5 Department of Medical Oncology, Lorraine Cancer Institute, Nancy, Nancy, France 6 Institute for Women’s Health, University College, London, UK 7 Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle, Halle,
Germany 8 Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre Mainz, Mainz, Germany 9 Rehabilitation Unit, Department of Health Policy, Farmacy and Quality of Life, Istituto Nazionale Tumori "Fondazione Giovanni Pascale"- IRCCS - Naples, Italy. 10 Department of Clinical Oncology, Tanta Faculty of Medicine, Egypt 11 Department of Radiation Oncology (MAASTRO), GROW (School for Oncology & Developmental Biology), University of Maastricht Medical Center, Maastricht, The Netherlands 12 Department of Psychiatry and Psychotherapy, Medical University of Innsbruck, Austria
13 Department of Medical Psychology and Medical Sociology, University of Leipzig, Germany 14 Department of Family Medicine, National Taiwan University, Taiwan 15 Research and Development Office, Southern Health NHS Foundation Trust, Southampton, UK
16 Medical Oncology Department, The Christie NHS Foundation Trust, Manchester, UK. 17 HPB Services Directorate of Surgery, University Hospital Aintree, Liverpool, UK 18 Institute of Research in Rehabilitation Medicine at Ulm University, Ulm, Germany 19 Department of Research Methods, University of Education, Freiburg, Germany 20 Department of Paediatric Psychiatry, University of Magdeburg, Magdeburg, Germany
21 Quality of Life Department, EORTC Headquarters, Brussels, Belgium
Address of correspondence:
Joachim Weis Prof. PhD. University Clinic Centre Freiburg Tumor Biology Clinic Department of Psycho-Oncology Breisacher Str. 117 79106 Freiburg Phone 0049-(0)761-206-2220
13. Arbuckle, J. IBM SPSS Amos™ 21 User’s Guide (Amos Development Corporation, Ed.) 2012.
14. Graham, J. W., Cumsille, P. E., Elek-Fisk, E. Methods for Handling Missing Data. In I. B. Weiner (Ed.),
Handbook of Psychology. Hoboken, NJ, USA: John Wiley & Sons, 2003.
15. Kline, R. B. Principles and practice of structural equation modeling (Methodology in the social sciences
3rd ed). New York: Guilford Press 2011.
16. Hair, J. F. Multivariate data analysis (7th ed). Upper Saddle River, NJ: Prentice Hall 2010.
17. Stone, P., Richards, M., A'Hern, R. & Hardy, J. (2000). A study to investigate the prevalence, severity
and correlates of fatigue among patients with cancer in comparison with a control group of volunteers
without cancer. Annals of Oncology,2000,11 (5), 561–567.
18. Radbruch L, Strasser F, Elsner F et al. Fatigue in palliative care patients - an EAPC approach. Palliat
Med, 2008, 22:13-32.
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Table 1 Overview: Design and analyses of the four groups Group A Group B Group C Group D
Points of measurement
t1 T1A ±7 days before or at the 1st day of treatment (adjuvant chemo-/radiotherapy) (n = 311)
T1B ±7 days before or at the 1st day of treatment (adjuvant chemo-/radiotherapy) (n = 222)
T1C after completion of any treatment for at least 12 respectively (n= 212)
T1C after completion of any treatment for at least 36 months (n=199)
t2 T2A ChTh: at the end of 2nd cycle or at the beginning of the 3rd cycle; Radioth.: at the end of the 4th week of radiotherapy (n= 279) (drop out: 10.3%)
T2B ChTh: at the end of 2nd cycle or at the beginning of the 3rd cycle; Radioth.: at the end of the 4th week of radiotherapy (n = 181) (drop out: 18.5%)
T2C re-test one week after first assessment (n=201) (drop-out: 5.1%)
T2C re-test one week after first assessment (n = 187) (drop-out: 6%)
t3 T3A at three months (range: 12-15 weeks) after treatment (n=243) (drop-out: 12.9%)
T3B at one month (range: 4-6 weeks) after treatment. (n =141) (drop-out: 22.1%)
- -
Analyses
Confirmatory Analyses
Confirmatory Analyses
Confirmatory Analyses
Confirmatory Analyses
Sensitivity to change
Sensitivity to change
Test Re-Test Reliability
Test- Re-Test Reliability
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Table 2 Sociodemographic and medical data
1 Due to the definition of groups C and D patients with metastases were excluded from the test-re-test analyses
Total n=946 (at t1 ABCD)
Total Sample
n = 946 (100%)
Group A Curative
treatment n=311
(32.9%)
Group B Palliative
Treatment n=222
(23.5%)
Group C off treatment
<12 months n=212
(22.4%)
Group D off treatment
>36 months n=199
(21.1%) Age Mean (SD) (N=943) 58.8 (13.1) 59.3 (14.0) 62.7 (11.6) 58.7 (12.9) 59.0 (13.5) Range 22-97 26-87 31-97 28-90 25-95 Sex
Table 3: Gobal indices of convergent and divergent validity of the revised model (n=944)
(data of t1ABCD)
c² p df c²/df GFI AGFI NFI RMSEA CFI TLI Thresholds for acceptable fit
>0.05
<3
≥ 0.90
≥ 0.90
≥ 0.90
≤ 0.08
≥ 0.90
≥ 0.90
Thresholds for good fit
>0.05
<3
≥ 0.95
≥ 0.95
≥ 0.95
≤ 0.05
≥ 0.95
≥ 0.95
EORTC QLQ-FA12 Original model t1 (EORTC-FA13)
788.8
<0.001
58
13.60
0.888
0.824
0.894
0.116
0.901
0.866
Modified model t1 (EORTC-FA12)
205.1
<0.001
47
4.36
0.965
0.942
0.970
0.060
0.976
0.967
Modified model t2
257.5 <.001 47 5.48 .957 .929 .966 .069 .972 .961
Modified model t3
342.4 <.001 47 7.28 .946 .911 .960 .82 .965 .951
GFI= Goodness of fit index, AGFI= adjusted goodness of fit index, NFI= normed fit index, RMSEA= root mean square error of approximation, CFI= comparative fit index, TLI= Tucker-Lewis index
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Table 4 Local indices of convergent and divergent validity of the revised model (n=944) (data of t1ABCD)
Factor Item Indicator-reliability
t-Value of factor loading
Factor-reliability
Average variance extracted
Cronbach’s α
Thresholds for acceptable fit1
≥ 0.4
≥ 0.6
≥ 0.5
>.70
Physical
FA01 FA02 FA03 FA04 FA052
.85 .87 .81 .73 .77
34.00 *** 30.57 *** 25.77 *** 28.03***
.90
.66
.90
Emotional
FA06 FA07 FA082
.82 .83 .79
26.89 *** 25.44***
.85
.66
.85
Cognitive
FA09 FA102
.87 .78
20.96 ***
.82
.70
.81
1 following [16]; 2 = no t-values, fixed reference parameters to standardize the variance of the construct *** = p <.001
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Table 5 Sensitivity to change in Group A (curative treatment) (MANOVA, data of t1A to t3A)
t1 t2 t3
Dimension M SD M SD M SD Pillai -Bartlett's V (df)
ηp² (partial eta-squared)
Pair wise comparison
Physical Fatigue n=225
1.99 0.79 2.33 0.79 2.05 0.76 26.59* (2,230)
0.19
t1 & t2* t2 & t3*
Emotional Fatigue n =230
1.78 0.76 1.89 0.70 1.68 0.74 13.87* (2,230)
0.11 t1 & t2* t2 & t3*
Cognitive Fatigue n = 228
1.45 0.56 1.58 0.59 1.43 0.56 11.38* (2,230)
0.09 t1 & t2* t2 & t3*
Multivariate effect of time n = 228
21.28***
(2,229) 0.16
Multivariate interaction effect of time and dimension n =228
9.72***
(4,227) 0.15
* = p <.05, *** = p <.001
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Table 6 Sensitivity to change in Group B (palliative treatment) (MANOVA, data of t1B to t3B)
t1 t2 t3 Dimension M SD M SD M SD Pillai
-Bartlett's V (df)
ηp² (eta-squared)
Pair wise comparison
Physical. Fatigue n = 135
2.30 0.79 2.36 0.77 2.44 0.79 1.73 (2,230)
0.03
n.s.
Emotional Fatigue n = 132
2.09 0.79 2.03 0.74 2.15 0.84 1.99 (2,230)
0.03
n.s.
Cognitive Fatigue n = 134
1.65 0.58 1.63 0.49 1.77 0.65 3.99* (2,230)
0.06
t2 & t3*
Multivariate effect of time n=132
2.89
(2,229) 0.04
Multivariate interaction effect of time and dimension n =132
1.4 (4,227)
0.04
* = p <.05
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Table 7 Internal reliability and intraclass correlation (data of t1CD, t2CD)
Dimension Cronbachs α t1 (group C & D) Cronbachs α t2 (group C & D) Intraclass Corr (group C and D) mean score Rt1-t2