Use of PROM during follow-up of patients with ovarian cancer: the PROMova study protocol.

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.