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Clinical trial
Use of PROM during follow-up of patients with ovarian cancer: the PROMova study protocol
  1. Anette Stolberg Kargo1,2,
  2. Angela Coulter2,3,
  3. Kristina Lindemann4,5,
  4. Pernille Tine Jensen6,7,
  5. Niels Henrik Hjøllund8,9,
  6. Berit Jul Mosgaard10 and
  7. Karina Dahl Steffensen1,2
  1. 1 Department of Oncology, Vejle Hospital- University Hospital of Southern Denmark, Vejle, Denmark
  2. 2 Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
  3. 3 Center for Shared Decision Making, Vejle Hospital, University Hospital of Southern Denmark, Vejle, Denmark
  4. 4 Department of Gynecological Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway
  5. 5 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway
  6. 6 Faculty of Health Science, Aarhus University, Aarhus, Denmark
  7. 7 Department of Gynaecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark
  8. 8 Faculty of Health, Institute of Clinical Medicine, Aarhus University Denmark, Aarhus, Denmark
  9. 9 AmbuFlex/WestChronic, Occupational Medicine, University Research Clinic, Aarhus University, Aarhus, Denmark
  10. 10 Department of Gynecology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
  1. Correspondence to Dr Anette Stolberg Kargo, Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle 7100, Denmark; Anette.Stolberg.Kargo{at}rsyd.dk

Abstract

Background There is a paucity of high-level evidence on the optimal follow-up of patients with ovarian cancer after primary treatment. A debate is ongoing on the extent to which follow-up should consider patient preferences and patient-reported outcome measures. Incorporation of patient-reported outcome measures supports the dialog between patient and clinician and may be instrumental in symptom monitoring and detection of underlying issues, especially when used actively during the clinical consultation.

Primary Objective and Endpoint The PROMova study aims to assess whether proactive use of patient-reported outcome measures during follow-up care increases patient involvement as perceived by the patient compared with standard care. Another objective is to measure satisfaction with the care provided.

Study Hypothesis It is hypothesized that proactive use of patient-reported outcome measures during the clinical encounter will improve patients’ experience of involvement in follow-up care.

Trial Design PROMova is a multi-center, observational cohort study collecting data from eight departments in Denmark. Five departments use the patient-reported outcome measures proactively during the consultation and three provide standard care. Participants are followed up with patient-reported outcome measures for up to 3 years. The patient-reported outcome measures package comprises EORTC QLQ-C30, EORTC QLQ-OV28, a questionnaire screening tool for recurrence, CollaboRATE, and selected questions from the Patient Experience Questionnaire.

Major Inclusion/Exclusion Criteria Patients older than 18 years diagnosed with ovarian, fallopian tube, or primary peritoneal cancer are eligible when entering the follow-up program after primary treatment. Participants must be able to speak and read Danish.

Sample Size 223 patients with ovarian cancer.

Estimated Dates for Completing Accrual and Presenting Results The protocol closed for enrollment in 2019. Publication of final results is expected in spring 2022.

Trial Registration PROMova was registered with ClinicalTrials.gov November 2016 Identifier: NCT02916875.

  • ovarian cancer
  • ovarian neoplasms
  • quality of life (PRO)/palliative care
  • medical oncology

https://doi.org/10.1136/ijgc-2020-001528

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    Footnotes

    • Contributors AK, the principal investigator of the trial, drafted this manuscript. K, BM, AC, and PTJ contributed to the study design and the manuscript. KL helped elaborate the study and has contributed to the draft of the article. NHH participated in the coordination of data collection using AmbuFlex. All authors have read and approved the final manuscript.

    • Funding The study is funded by The Danish Cancer Society and the Research Council of Lillebaelt Hospital, neither of which were involved in the design of the study.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The trial approved by The Danish Data Protection Agency (16/1586). Approval by The Regional Committees on Health Research Ethics for Southern Denmark was not required due to the survey based and observational nature of the project.

    • Provenance and peer review Commissioned; externally peer reviewed.

    • Data availability statement Data are available upon request