This study develops and tests whether a telehealth program called REVITALIZE can help manage PARP inhibitor-related fatigue in patients with ovarian cancer that has spread to other places in the body (advanced). Fatigue is a common symptom that patients taking PARP inhibitors experience. REVITALIZE is a 6-week telehealth intervention that uses a structured, skills-based intervention model to provide support, knowledge, and skills for coping with fatigue. This program may help to reduce the impact of fatigue on daily life and activities, and improve symptoms and quality of life in patients with ovarian cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04525183.
PRIMARY OBJECTIVES:
I. To assess the feasibility and acceptability of REVITALIZE in women with advanced ovarian cancer who experience PARP inhibitors (PARPi)-related fatigue.
II. To explore the effects of REVITALIZE on fatigue, emotional distress, fear of cancer recurrence, quality of life, and adherence in 50 women with advanced ovarian cancer on PARPi.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (REVITALIZE): Patients participate in the REVITALIZE program consisting of telehealth sessions over 60-75 minutes once weekly (QW) for 6-8 weeks and psychoeducation about PARPi-related fatigue. Patients also complete interviews at baseline and at 4, 8, and 12 weeks.
ARM II (ENHANCED USUAL CARE): Patients receive enhanced usual care consisting of educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment, and printed information about supportive care resources at their site.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAlexi Anne Wright
