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.
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Acknowledgements
In Australia, the study was coordinated by the NHMRC Clinical Trials Centre, University of Sydney. The Cancer Research UK and UCL Cancer Trials Centre coordinated UK participation in the study.
Funding
In Australia the study was supported by NHMRC grants 1063012 and 570,893. In the United Kingdom (UK), this was a National Institute for Health Research (NIHR) study jointly funded by Target Ovarian Cancer (UCL-P001AL) and the Cancer Research UK and UCL Cancer Trials Centre (Programme Grant C444/A15953). Professor King is supported by the Australian Government through Cancer Australia. Professor Friedlander is supported by an NHMRC Program grant. Dr Anne Lanceley was assisted by the National Institute for Health Research (NIHR) UCLH/UCL Biomedical Research Centre which is supported by the Department of Health.
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GCIG-SBS was led and coordinated by the Australian New Zealand Gynecological Oncology Group (ANZGOG) and National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, in collaboration with the GCIG Symptom Benefit Committee. The trial was registered on the Australian New Zealand Clinical Trials Registry (ANZCTR 12607000603415). The study was performed in accordance with the NHMRC Statement on Ethical Conduct in Research Involving Humans and the Declaration of Helsinki, with ethics approval at all participating sites, and signed, written, and informed consent was obtained from all participants.
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King, M.T., Stockler, M.R., O’Connell, R.L. et al. Measuring what matters MOST: validation of the Measure of Ovarian Symptoms and Treatment, a patient-reported outcome measure of symptom burden and impact of chemotherapy in recurrent ovarian cancer. Qual Life Res 27, 59–74 (2018). https://doi.org/10.1007/s11136-017-1729-8
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DOI: https://doi.org/10.1007/s11136-017-1729-8