Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
Dana-Farber Cancer Institute
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
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…