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Quality of Life Research

, Volume 27, Issue 1, pp 59–74 | Cite as

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

  • Madeleine T. King
  • Martin R. Stockler
  • Rachel L. O’Connell
  • Luke Buizen
  • Florence Joly
  • Anne Lanceley
  • Felix Hilpert
  • Aikou Okamoto
  • Eriko Aotani
  • Jane Bryce
  • Paul Donnellan
  • Amit Oza
  • Elisabeth Avall-Lundqvist
  • Jonathan S. Berek
  • Jalid Sehouli
  • Amanda Feeney
  • Dominique Berton-Rigaud
  • Daniel S. J. Costa
  • Michael L. Friedlander
  • for the GCIG Symptom Benefit group
Special Section: Measuring What Matters (by invitation only)

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.

Keywords

Ovarian cancer Recurrent ovarian cancer Platinum sensitive Platinum resistant Platinum refractory Symptom burden Symptom benefit Magnitude of clinical benefit Net health benefit Patient-reported outcome PRO Patient-reported outcome measure PROM Quality of life QOL Health-related quality of life HRQOL HRQL 

Notes

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.

Compliance with ethical standards

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.

Supplementary material

11136_2017_1729_MOESM1_ESM.pdf (2.1 mb)
Supplementary material 1 (PDF 2125 KB)

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Copyright information

© Springer International Publishing AG, part of Springer Nature  2017

Authors and Affiliations

  • Madeleine T. King
    • 1
    • 2
    • 3
  • Martin R. Stockler
    • 3
    • 4
  • Rachel L. O’Connell
    • 4
  • Luke Buizen
    • 4
  • Florence Joly
    • 5
    • 6
  • Anne Lanceley
    • 7
  • Felix Hilpert
    • 8
    • 9
  • Aikou Okamoto
    • 10
    • 11
  • Eriko Aotani
    • 12
    • 13
  • Jane Bryce
    • 14
    • 15
  • Paul Donnellan
    • 16
  • Amit Oza
    • 17
    • 18
  • Elisabeth Avall-Lundqvist
    • 19
    • 20
    • 21
  • Jonathan S. Berek
    • 22
    • 23
  • Jalid Sehouli
    • 9
    • 24
  • Amanda Feeney
    • 25
  • Dominique Berton-Rigaud
    • 6
    • 26
  • Daniel S. J. Costa
    • 2
    • 27
  • Michael L. Friedlander
    • 3
    • 28
  • for the GCIG Symptom Benefit group
    • 29
  1. 1.Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, Faculty of ScienceUniversity of SydneySydneyAustralia
  2. 2.Sydney Medical School, Faculty of MedicineUniversity of SydneySydneyAustralia
  3. 3.Australia New Zealand Gynaecological Oncology Group (ANZGOG)CamperdownAustralia
  4. 4.National Health and Medical Research Council (NHMRC) Clinical Trials CentreUniversity of SydneySydneyAustralia
  5. 5.Centre Francois BaclesseCaenFrance
  6. 6.Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO)ParisFrance
  7. 7.UCL Elizabeth Garrett Anderson Institute for Women’s HealthUniversity College LondonLondonUK
  8. 8.Onkologisches Therapiezentrum am Krankenhaus Jerusalem HamburgHamburgGermany
  9. 9.Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe (AGO Study Group)WiesbadenGermany
  10. 10.Jikei University School of MedicineTokyoJapan
  11. 11.Japanese Gynecologic Oncology Group (JGOG)TokyoJapan
  12. 12.Global Health Research Coordinating CenterKanagawa Academy of Science and TechnologyKanagawaJapan
  13. 13.Gynecologic Oncology Trial and Investigation Consortium (GOTIC)SaitamaJapan
  14. 14.Istituto Nazionale Tumori - IRCCS - Fondazione G.PascaleNapoliItaly
  15. 15.Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) GroupNapoliItaly
  16. 16.Cancer Trials IrelandGalway University HospitalGalwayIreland
  17. 17.Princess Margaret Cancer CentreUniversity of TorontoTorontoCanada
  18. 18.Princess Margaret Consortium (PMHC)TorontoCanada
  19. 19.Department of Oncology and Department of Clinical and Experimental MedicineLinkoping University, NSGOLinkopingSweden
  20. 20.Department of Oncology-PathologyKarolinska InstitutetStockholmSweden
  21. 21.Nordic Society of Gynaecological Oncology (NSGO)CopenhagenDenmark
  22. 22.Stanford Comprehensive Cancer InstituteStanfordUSA
  23. 23.Cooperative Ovarian Cancer Group (COGi)StanfordUSA
  24. 24.Department of Gynecology and Oncological Surgery, CharitéUniversity of BerlinBerlinGermany
  25. 25.Cancer Research UK and UCL Cancer Trials CentreUniversity College LondonLondonUK
  26. 26.Institut de Cancerologie de l’Ouest (ICO)Centre René GauducheauSaint HerblainFrance
  27. 27.Pain Management Research InstituteRoyal North Shore HospitalSt LeonardsAustralia
  28. 28.Prince of Wales Clinical SchoolUniversity of New South WalesSydneyAustralia
  29. 29.On behalf of the GCIG Symptom Benefit Study Group, Gynecologic Cancer Intergroup (GCIG)KingstonCanada

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