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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

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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.

Author information

Authors and Affiliations

  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 T. King

  2. Sydney Medical School, Faculty of Medicine, University of Sydney, Sydney, NSW, Australia

    Madeleine T. King & Daniel S. J. Costa

  3. Australia New Zealand Gynaecological Oncology Group (ANZGOG), Camperdown, Australia

    Madeleine T. King, Martin R. Stockler & Michael L. Friedlander

  4. National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

    Martin R. Stockler, Rachel L. O’Connell & Luke Buizen

  5. Centre Francois Baclesse, Caen, France

    Florence Joly

  6. Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Paris, France

    Florence Joly & Dominique Berton-Rigaud

  7. UCL Elizabeth Garrett Anderson Institute for Women’s Health, University College London, London, UK

    Anne Lanceley

  8. Onkologisches Therapiezentrum am Krankenhaus Jerusalem Hamburg, Hamburg, Germany

    Felix Hilpert

  9. Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe (AGO Study Group), Wiesbaden, Germany

    Felix Hilpert & Jalid Sehouli

  10. Jikei University School of Medicine, Tokyo, Japan

    Aikou Okamoto

  11. Japanese Gynecologic Oncology Group (JGOG), Tokyo, Japan

    Aikou Okamoto

  12. Global Health Research Coordinating Center, Kanagawa Academy of Science and Technology, Kanagawa, Japan

    Eriko Aotani

  13. Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Saitama, Japan

    Eriko Aotani

  14. Istituto Nazionale Tumori - IRCCS - Fondazione G.Pascale, Napoli, Italy

    Jane Bryce

  15. Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) Group, Napoli, Italy

    Jane Bryce

  16. Cancer Trials Ireland, Galway University Hospital, Galway, Ireland

    Paul Donnellan

  17. Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada

    Amit Oza

  18. Princess Margaret Consortium (PMHC), Toronto, Canada

    Amit Oza

  19. Department of Oncology and Department of Clinical and Experimental Medicine, Linkoping University, NSGO, Linkoping, Sweden

    Elisabeth Avall-Lundqvist

  20. Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

    Elisabeth Avall-Lundqvist

  21. Nordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark

    Elisabeth Avall-Lundqvist

  22. Stanford Comprehensive Cancer Institute, Stanford, CA, USA

    Jonathan S. Berek

  23. Cooperative Ovarian Cancer Group (COGi), Stanford, CA, USA

    Jonathan S. Berek

  24. Department of Gynecology and Oncological Surgery, Charité, University of Berlin, Berlin, Germany

    Jalid Sehouli

  25. Cancer Research UK and UCL Cancer Trials Centre, University College London, London, UK

    Amanda Feeney

  26. Institut de Cancerologie de l’Ouest (ICO), Centre René Gauducheau, Saint Herblain, France

    Dominique Berton-Rigaud

  27. Pain Management Research Institute, Royal North Shore Hospital, St Leonards, NSW, Australia

    Daniel S. J. Costa

  28. Prince of Wales Clinical School, University of New South Wales, Sydney, Australia

    Michael L. Friedlander

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  1. Madeleine T. King
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  2. Martin R. Stockler
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  3. Rachel L. O’Connell
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for the GCIG Symptom Benefit group

Corresponding author

Correspondence to Madeleine T. King.

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Conflict of interest

The authors declared that they have no conflicts of interest in relation to the material presented in this paper.

Ethical approval

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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