Sally J Wheelwright1, Jane B Hopkinson2, Anne-Sophie Darlington3, Deborah F Fitzsimmons4, Peter Fayers5, Trude R Balstad6, Anne Bredart7, Eva Hammerlid8, Stein Kaasa6, Ourania Nicolatou-Galitis9, Monica Pinto10, Heike Schmidt11, Tora S Solheim6, Florian Strasser12, Iwona M Tomaszewska13, Colin D Johnson14. 1. Cancer Sciences, University of Southampton, Southampton, UK. Electronic address: S.J.Wheelwright@soton.ac.uk. 2. Cardiff School of Healthcare Sciences, Cardiff University, Cardiff, UK. 3. Health Sciences, University of Southampton, Southampton, UK. 4. Swansea Centre for Health Economics, Swansea University, Swansea, UK. 5. Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. 6. European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. 7. Institut Curie, Paris, France; University Paris Descartes, Paris, France. 8. Department of Otolaryngology Head & Neck Surgery, Sahlgrenska University Hospital, Goteborg, Sweden. 9. University of Athens, Athens, Greece. 10. Istituto Nazionale Tumori "Fondazione Giovanni Pascale" - IRCCS, Naples, Italy. 11. Institute of Health and Nursing Sciences, Martin-Luther-University Halle-Wittenberg, Halle, Germany. 12. Cantonal Hospital, St Gallen, St Gallen, Switzerland. 13. Department of Medical Education, Jagiellonian University Medical College, Cracow, Poland. 14. Cancer Sciences, University of Southampton, Southampton, UK.
Abstract
CONTEXT: Cachexia is commonly found in cancer patients and has profound consequences; yet there is only one questionnaire that examines the patient's perspective. OBJECTIVE: To report a rigorously developed module for patient self-reported impact of cancer cachexia. METHODS: Module development followed published guidelines. Patients from across the cancer cachexia trajectory were included. In Phase 1, health-related quality of life (HRQOL) issues were generated from a literature review and interviews with patients in four countries. The issues were revised based on patient and health care professional (HCP) input. In Phase 2, questionnaire items were formulated and translated into the languages required for Phase 3, the pilot phase, in which patients from eight countries scored the relevance and importance of each item, and provided qualitative feedback. RESULTS: A total of 39 patients and 12 HCPs took part in Phase 1. The literature review produced 68 HRQOL issues, with 22 new issues arising from the patient interviews. After patient and HCP input, 44 issues were formulated into questionnaire items in Phase 2. One hundred ten patients took part in Phase 3. One item was reworded, and 20 items were deleted as a consequence of patient feedback. CONCLUSIONS: The QLQ-CAX24 is a cancer cachexia-specific questionnaire, comprising 24 items, for HRQOL assessment in clinical trials and practice. It contains five multi-item scales (food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline) and four single items.
CONTEXT: Cachexia is commonly found in cancerpatients and has profound consequences; yet there is only one questionnaire that examines the patient's perspective. OBJECTIVE: To report a rigorously developed module for patient self-reported impact of cancer cachexia. METHODS: Module development followed published guidelines. Patients from across the cancer cachexia trajectory were included. In Phase 1, health-related quality of life (HRQOL) issues were generated from a literature review and interviews with patients in four countries. The issues were revised based on patient and health care professional (HCP) input. In Phase 2, questionnaire items were formulated and translated into the languages required for Phase 3, the pilot phase, in which patients from eight countries scored the relevance and importance of each item, and provided qualitative feedback. RESULTS: A total of 39 patients and 12 HCPs took part in Phase 1. The literature review produced 68 HRQOL issues, with 22 new issues arising from the patient interviews. After patient and HCP input, 44 issues were formulated into questionnaire items in Phase 2. One hundred ten patients took part in Phase 3. One item was reworded, and 20 items were deleted as a consequence of patient feedback. CONCLUSIONS: The QLQ-CAX24 is a cancer cachexia-specific questionnaire, comprising 24 items, for HRQOL assessment in clinical trials and practice. It contains five multi-item scales (food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline) and four single items.
Authors: Trude R Balstad; Erik T Løhre; Lene Thoresen; Morten Thronæs; Laila S Skjelvan; Ragnhild G Helgås; Tora S Solheim; Kari Sand Journal: Oncol Ther Date: 2022-02-24