Madeleine T King1,2,3, Martin R Stockler4,5, Rachel L O'Connell5, Luke Buizen5, Florence Joly6,7, Anne Lanceley8, Felix Hilpert9,10, Aikou Okamoto11,12, Eriko Aotani13,14, Jane Bryce15,16, Paul Donnellan17, Amit Oza18,19, Elisabeth Avall-Lundqvist20,21,22, Jonathan S Berek23,24, Jalid Sehouli10,25, Amanda Feeney26, Dominique Berton-Rigaud7,27, Daniel S J Costa28,29, Michael L Friedlander4,30. 1. Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, Faculty of Science, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia. madeleine.king@sydney.edu.au. 2. Sydney Medical School, Faculty of Medicine, University of Sydney, Sydney, NSW, Australia. madeleine.king@sydney.edu.au. 3. Australia New Zealand Gynaecological Oncology Group (ANZGOG), Camperdown, Australia. madeleine.king@sydney.edu.au. 4. Australia New Zealand Gynaecological Oncology Group (ANZGOG), Camperdown, Australia. 5. National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. 6. Centre Francois Baclesse, Caen, France. 7. Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Paris, France. 8. UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK. 9. Onkologisches Therapiezentrum am Krankenhaus Jerusalem Hamburg, Hamburg, Germany. 10. Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe (AGO Study Group), Wiesbaden, Germany. 11. Jikei University School of Medicine, Tokyo, Japan. 12. Japanese Gynecologic Oncology Group (JGOG), Tokyo, Japan. 13. Global Health Research Coordinating Center, Kanagawa Academy of Science and Technology, Kanagawa, Japan. 14. Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Saitama, Japan. 15. Istituto Nazionale Tumori - IRCCS - Fondazione G.Pascale, Napoli, Italy. 16. Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) Group, Napoli, Italy. 17. Cancer Trials Ireland, Galway University Hospital, Galway, Ireland. 18. Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada. 19. Princess Margaret Consortium (PMHC), Toronto, Canada. 20. Department of Oncology and Department of Clinical and Experimental Medicine, Linkoping University, NSGO, Linkoping, Sweden. 21. Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. 22. Nordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark. 23. Stanford Comprehensive Cancer Institute, Stanford, CA, USA. 24. Cooperative Ovarian Cancer Group (COGi), Stanford, CA, USA. 25. Department of Gynecology and Oncological Surgery, Charité, University of Berlin, Berlin, Germany. 26. Cancer Research UK and UCL Cancer Trials Centre, University College London, London, UK. 27. Institut de Cancerologie de l'Ouest (ICO), Centre René Gauducheau, Saint Herblain, France. 28. Sydney Medical School, Faculty of Medicine, University of Sydney, Sydney, NSW, Australia. 29. Pain Management Research Institute, Royal North Shore Hospital, St Leonards, NSW, Australia. 30. Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.
Abstract
PURPOSE: Gynecologic Cancer Intergroup Symptom Benefit Study (GCIG-SBS) Stage 2 aimed to review, revise, and validate a patient-reported outcome measure (PROM), the Measure of Ovarian Symptoms and Treatment concerns (MOST), developed in GCIG-SBS Stage 1 (MOSTv1, 35 items), and document recurrent ovarian cancer (ROC) symptom burden and benefit. METHODS: GCIG-SBS Stage 2 recruited patients with platinum-resistant/refractory ROC (PRR-ROC) or potentially platinum-sensitive ROC with ≥ 3 lines of prior chemotherapy (PPS-ROC ≥ 3). Patients completed MOSTv1, QLQ-C30, QLQ-OV28, and FACT-O/FOSI at baseline and before cycle 3 of chemotherapy (pre-C3), and global assessments of change (MOST-Change) pre-C3. Clinicians rated patients' cancer-related symptoms, performance status, and adverse events. Convergent and divergent validity (Spearman's correlations), discriminative validity (effect sizes between groups classified by clinician-rated characteristics), and responsiveness (paired t tests in patients expected to experience clinically meaningful change) were assessed. RESULTS: Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC ≥ 3. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being. Correlations confirmed concurrent and divergent validity. Discriminative validity was confirmed by effect sizes that conformed with a priori hypotheses. MOST-Abdo was responsive to improvements in abdominal symptoms and MOST-Chemo detected the adverse effects of chemotherapy. CONCLUSIONS: The MOSTv2 validly quantifies patient-reported symptom burden, adverse effects, and symptom benefit in ROC, and as such is fit-for-purpose for clinical trials of palliative chemotherapy in ROC. Further research is required to assess test-retest reliability.
PURPOSE: Gynecologic Cancer Intergroup Symptom Benefit Study (GCIG-SBS) Stage 2 aimed to review, revise, and validate a patient-reported outcome measure (PROM), the Measure of Ovarian Symptoms and Treatment concerns (MOST), developed in GCIG-SBS Stage 1 (MOSTv1, 35 items), and document recurrent ovarian cancer (ROC) symptom burden and benefit. METHODS: GCIG-SBS Stage 2 recruited patients with platinum-resistant/refractory ROC (PRR-ROC) or potentially platinum-sensitive ROC with ≥ 3 lines of prior chemotherapy (PPS-ROC ≥ 3). Patients completed MOSTv1, QLQ-C30, QLQ-OV28, and FACT-O/FOSI at baseline and before cycle 3 of chemotherapy (pre-C3), and global assessments of change (MOST-Change) pre-C3. Clinicians rated patients' cancer-related symptoms, performance status, and adverse events. Convergent and divergent validity (Spearman's correlations), discriminative validity (effect sizes between groups classified by clinician-rated characteristics), and responsiveness (paired t tests in patients expected to experience clinically meaningful change) were assessed. RESULTS: Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC ≥ 3. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being. Correlations confirmed concurrent and divergent validity. Discriminative validity was confirmed by effect sizes that conformed with a priori hypotheses. MOST-Abdo was responsive to improvements in abdominal symptoms and MOST-Chemo detected the adverse effects of chemotherapy. CONCLUSIONS: The MOSTv2 validly quantifies patient-reported symptom burden, adverse effects, and symptom benefit in ROC, and as such is fit-for-purpose for clinical trials of palliative chemotherapy in ROC. Further research is required to assess test-retest reliability.
Entities:
Keywords:
HRQL; HRQOL; Health-related quality of life; Magnitude of clinical benefit; Net health benefit; Ovarian cancer; PRO; PROM; Patient-reported outcome; Patient-reported outcome measure; Platinum refractory; Platinum resistant; Platinum sensitive; QOL; Quality of life; Recurrent ovarian cancer; Symptom benefit; Symptom burden
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