REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
NCT06710548 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-04-13
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
Conditions
- Ovarian Cancer
- Advanced Ovarian Carcinoma
- Fallopian Tube Carcinoma
- Primary Peritoneal Cancer
- PARP Inhibitor
- Fatigue Related to Cancer Treatment
- Fatigue in Cancer Survivors
Interventions
- 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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Alexi A Wright, MD, MPH · Dana-Farber Cancer Institute
-
Joanna J Arch, PhD · University of Colorado, Boulder
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-17
- Primary Completion
- 2028-12-31
- Completion
- 2029-01-31
Countries
- United States
Study Locations
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