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NCT06710548NARecruiting

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

Dana-Farber Cancer Institute

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

Inclusion Criteria: * Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy). * Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months. * English-speaking. * Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory. * ECOG performance status of 0-2. * Willing to use a wireless pill bottle for PARP inhibitor medication. Exclusion Criteria: * Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist. * Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide. * Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures. * Inability to complete the first questionnaire within one week of consent.

Interventions

BEHAVIORAL

REVITALIZE Intervention

BEHAVIORAL

Educational Materials

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Conditions

Ovarian CancerAdvanced Ovarian CarcinomaFallopian Tube CarcinomaPrimary Peritoneal CancerPARP InhibitorFatigue Related to Cancer TreatmentFatigue in Cancer Survivors

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