Joachim Weis1, Markus A Wirtz2, Krzysztof A Tomaszewski3, Eva Hammerlid4, Juan Ignacio Arraras5, Thierry Conroy6, Anne Lanceley7, Heike Schmidt8, Susanne Singer9, Monica Pinto10, Mohamed Alm El-Din11, Inge Compter12, Bernhard Holzner13, Dirk Hofmeister14, Wei-Chu Chie15, Amelie Harle16, Hans-Henning Flechtner17, Andrew Bottomley18. 1. Comprehensive Cancer Center, University Clinic Center Freiburg, Freiburg, Germany. 2. Department of Research Methods, University of Education, Freiburg, Germany. 3. Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Kraków, Poland. 4. Department of Otolaryngology Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden. 5. Oncology Department, Complejo Hospitalario de Navarra, Pamplona, Spain. 6. Department of Medical Oncology, Lorraine Cancer Institute, Institut de Cancérologie de Lorraine et Université de Lorraine, Nancy, France. 7. Institute for Women's Health, University College London, London, UK. 8. Institute of Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle, Germany. 9. Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre Mainz, Mainz, Germany. 10. Department of Supportive Care, Rehabilitation Medicine Unit, Istituto Nazionale Tumori - IRCCS - "Fondazione G. Pascale", Napoli, Italy. 11. Department of Clinical Oncology, Tanta Faculty of Medicine, Tanta, Egypt. 12. Department of Radiation Oncology (MAASTRO), GROW (School for Oncology and Developmental Biology), University of Maastricht Medical Center, Maastricht, The Netherlands. 13. Department of Psychiatry and Psychotherapy, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria. 14. Department of Medical Psychology and Medical Sociology, University of Leipzig, Leipzig, Germany. 15. Department of Family Medicine, National Taiwan University, Taipei, Taiwan. 16. Medical Oncology Department, The Christie NHS Foundation Trust, Manchester, UK. 17. Department of Paediatric Psychiatry, University of Magdeburg, Magdeburg, Germany. 18. Quality of Life Department, EORTC Headquarters, Brussels, Belgium.
Abstract
OBJECTIVE: The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has developed a multidimensional instrument measuring cancer-related fatigue, the EORTC QLQ-FA12. The analysis of sensitivity to change is an essential part of psychometric validation. With this study, we investigated the EORTC QLQ-FA12's sensitivity to change. METHODS: The methodology follows the EORTC guidelines of EORTC QLG for phase IV validation of modules. We included cancer patients undergoing curative and palliative treatment at t1 and followed them up prospectively over the course of their treatment (t2) and 4 weeks after completion of treatment (t3). Data were collected prospectively at 17 sites in 11 countries. Sensitivity to change was investigated using analysis of variance. RESULTS: A total sample of 533 patients was enrolled with various tumour types, different stages of cancer, and receiving either curative treatment (n=311) or palliative treatment (n=222). Over time all fatigue scores were significantly higher in the palliative treatment group compared with the curative group (p < .001). Physical fatigue increased with medium effect size over the course of treatment in the curative group (standardized response mean [SRM] (t1,t2) = 0.44]. After treatment physical [SRM (t2,t3) = 0.39], emotional [SRM (t2,t3)= 0.28] and cognitive fatigue (SRM [t2,t3] = 0.22) declined significantly in the curative group. In the palliative group, emotional (SRM [t2,t3] = 0.18) as well as cognitive [SRM [t2,t3] = 0.26) fatigue increases significantly. CONCLUSIONS: The EORTC-QLQ-FA12 proved to identify clinically significant changes in fatigue in the course of curative and palliative cancer treatment.
OBJECTIVE: The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has developed a multidimensional instrument measuring cancer-related fatigue, the EORTC QLQ-FA12. The analysis of sensitivity to change is an essential part of psychometric validation. With this study, we investigated the EORTC QLQ-FA12's sensitivity to change. METHODS: The methodology follows the EORTC guidelines of EORTC QLG for phase IV validation of modules. We included cancerpatients undergoing curative and palliative treatment at t1 and followed them up prospectively over the course of their treatment (t2) and 4 weeks after completion of treatment (t3). Data were collected prospectively at 17 sites in 11 countries. Sensitivity to change was investigated using analysis of variance. RESULTS: A total sample of 533 patients was enrolled with various tumour types, different stages of cancer, and receiving either curative treatment (n=311) or palliative treatment (n=222). Over time all fatigue scores were significantly higher in the palliative treatment group compared with the curative group (p < .001). Physical fatigue increased with medium effect size over the course of treatment in the curative group (standardized response mean [SRM] (t1,t2) = 0.44]. After treatment physical [SRM (t2,t3) = 0.39], emotional [SRM (t2,t3)= 0.28] and cognitive fatigue (SRM [t2,t3] = 0.22) declined significantly in the curative group. In the palliative group, emotional (SRM [t2,t3] = 0.18) as well as cognitive [SRM [t2,t3] = 0.26) fatigue increases significantly. CONCLUSIONS: The EORTC-QLQ-FA12 proved to identify clinically significant changes in fatigue in the course of curative and palliative cancer treatment.
Keywords:
EORTC quality of life group; cancer-related fatigue; international field validation; module development; quality of life; sensitivity to change
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