Randomized Trial of REVITALIZE Telehealth Program to Reduce Fatigue in Adult Women with Advanced Ovarian Cancer Taking PARP Inhibitors

What this Trial Is About

Researchers are evaluating whether a supportive telehealth program called REVITALIZE can reduce fatigue and its impact on daily life for adult women with ovarian cancer who are taking PARP inhibitors. This Phase 3 randomized trial compares the REVITALIZE intervention to receiving educational materials about cancer survivorship and fatigue management. The study is funded by the National Cancer Institute and involves about 240 participants. Participants will be randomly assigned to one of two groups. The REVITALIZE group will have eight weekly one-on-one coaching sessions plus two booster sessions conducted via Zoom, focusing on fatigue education, Acceptance and Commitment Therapy skills, and behavior changes. The other group will receive specialized educational materials on managing fatigue. Both groups will use a wireless pill bottle to track their PARP inhibitor medication. Participants will complete questionnaires at enrollment and at 8, 13, 20, and 28 weeks to measure fatigue interference, fatigue severity, sleep disturbance, quality of life, emotional distress, and medication adherence. The primary outcome is the change in fatigue interference score from baseline to 20 weeks. The study duration is about seven months, during which participants will be monitored for adherence and outcomes using surveys and pill bottle data.

REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors