REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
Start Date
3/17/2025
Completion Date
1/31/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
REVITALIZE Intervention
Educational Materials
Conditions
Locations
University of Colorado Cancer Center-Anschutz
Aurora, Colorado 80045
United States
University of Colorado Boulder
Boulder, Colorado 80309
United States
Massachusetts General Hospital-Cancer Center
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Duke Cancer Center
Durham, North Carolina 27710
United States