Actively Recruiting
Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
Led by Dana-Farber Cancer Institute · Updated on 2026-04-13
240
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients aged 18 years or older with ovarian, fallopian tube, or primary peritoneal cancer who have completed surgery and chemotherapy.
- Currently treated with a PARP inhibitor as maintenance therapy for at least 2 months and planning to continue for at least 7 months.
- English-speaking.
- Have a mean fatigue severity score of 4 or higher on the first three items of the Fatigue Symptom Inventory.
- Have an ECOG performance status between 0 and 2.
- Willing and able to use a wireless pill bottle for PARP inhibitor medication.
You will not qualify if you...
- Untreated medical or other health conditions that existed before starting PARP inhibitors that could explain fatigue.
- Severe psychiatric conditions requiring more intensive treatment than the study can provide.
- Cognitive conditions that prevent informed consent or completing study procedures.
- Inability to complete the first questionnaire within one week after consenting to participate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - 8 to 10 weeks
Participants receive either the REVITALIZE telehealth intervention involving weekly one-on-one coaching sessions via Zoom or educational materials on cancer survivorship. Both groups use a wireless pill bottle to monitor PARP inhibitor medication adherence and complete questionnaires throughout this period.
8 weekly sessions and 2 booster sessions (via Zoom) for the intervention group; questionnaires and pill bottle usage for all participants at baseline, 8, 13, 20, and 28 weeks
Duration - Up to 28 weeks
Participants continue to complete follow-up questionnaires to assess fatigue, quality of life, emotional distress, and medication adherence up to 28 weeks after enrollment.
Questionnaires at 13, 20, and 28 weeks
Trial Site Locations
Total: 6 locations
1
University of Colorado Cancer Center-Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Colorado Boulder
Boulder, Colorado, United States, 80309
Actively Recruiting
3
Massachusetts General Hospital-Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
H
Hannah Park, BS
I
Irene Wang, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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