RecruitingNot ApplicableNCT06710548

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

Sponsor

Dana-Farber Cancer Institute

Enrollment

240 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured exercise and wellness program (REVITALIZE) can reduce severe fatigue in women with ovarian cancer who are taking PARP inhibitor maintenance therapy. **You may be eligible if...** - You are 18 or older with ovarian, fallopian tube, or primary peritoneal cancer - You have finished your primary treatment (surgery and chemotherapy) - You are currently on a PARP inhibitor (like olaparib, niraparib, or rucaparib) for at least 2 months and plan to continue for at least 7 more months - You speak English - You have moderate to severe fatigue - You are willing to use a wireless pill bottle to track your medication **You may NOT be eligible if...** - You have an untreated condition that could explain your fatigue (unrelated to cancer) - You have severe untreated psychiatric conditions, such as unresolved trauma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALREVITALIZE 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.

BEHAVIORALEducational Materials

The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute