Background Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies.
Primary Objective(s) To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment.
Study Hypothesis We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective.
Trial Design Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1.
Major Inclusion/Exclusion Criteria Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy.
Primary Endpoint(s) Emotional wellbeing at 12 months.
Sample Size 150 patients.
Estimated Dates for Completing Accrual and Presenting Results July 2023. Results expected in 2025, 24 months after the last participant is enrolled.
Trial Registration ACTRN12620000332921
- ovarian cancer
- quality of life (PRO)/palliative care
Data availability statement
There are no data in this work.
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Contributors Substantial contributions to the conception or design: all authors. PAC is the principal investigator of the trial and drafted the manuscript. Drafting the work and revising it critically for important intellectual content: all authors. Final approval of the version published: all authors. Agreement to be accountable for all aspects of the work: all authors.
Funding The study is funded by the Western Australia Health Translation Network’s Health Service Translational Research Project Grant, the Australian Government’s Medical Research Future Fund, the Australia and New Zealand Gynaecological Oncology Group (ANZGOG), and the Ladybird Foundation.
Competing interests PAC reports honoraria from Seqirus and Astra Zeneca unrelated to the submitted work. AO reports grants, personal fees, and other funding from SurgicalPerformance PTY Ltd, and grants from Medtronic, not directly related to the subject of this manuscript; consultancy fees from Baxter Healthcare Australia and New Zealand and Astra Zeneca Australia, not directly related to the subject of this manuscript; and a trademark licensed to SurgicalPerformance Pty Ltd. PB reports honoraria from GSK. MF reports grants from Astra Zeneca, Novartis, and Beigene; consulting fees from Astra Zeneca, Novartis, GSK, MSF, Takeda, and Lilly; honoraria from Astra Zeneca, GSK, and ACT Genomics; and support for travel from Astra Zeneca, unrelated to the submitted work. MK, MF, PMW, RC, and PAC developed the MOST-S26.
Provenance and peer review Commissioned; internally peer reviewed.
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