NCT06710548

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

Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors. The name of the study groups in this research study are: 1. REVITALIZE 2. Educational Materials

Detailed description

This Phase 3 randomized controlled trial will evaluate the effect of a brief, acceptance-based tele-health intervention (REVITALIZE) vs. educational materials in participants with ovarian cancer who are taking poly-ADP ribose polymerase (PARP) inhibitors. Participants will be randomized into one of two study groups: 1) REVITALIZE or 2) Educational Materials. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, using a wireless pill bottle, and completing questionnaires. Participation in this research study is expected to last about 7 months. It is expected about 240 people will take part in this research study. The National Cancer Institute is supporting this research by providing funding.

Conditions

• Ovarian Cancer
• Advanced Ovarian Carcinoma
• Fallopian Tube Carcinoma
• Primary Peritoneal Cancer
• PARP Inhibitor
• Fatigue Related to Cancer Treatment
• Fatigue in Cancer Survivors

Interventions

Type	Name	Description
BEHAVIORAL	REVITALIZE Intervention	A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via the Zoom platform and will either be videotaped or audiotaped.
BEHAVIORAL	Educational Materials	The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute

Timeline

• Start date: 2025-03-17
• Primary completion: 2028-12-31
• Completion: 2029-01-31
• First posted: 2024-11-29
• Last updated: 2026-04-13

Locations

6 sites across 1 country: United States