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
Trial Details
| Condition | Ovarian Cancer, Advanced Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Cancer, PARP Inhibitor, Fatigue Related to Cancer Treatment, Fatigue in Cancer Survivors |
| Intervention | REVITALIZE Intervention; Educational Materials |
| Phase | NA |
| Status | Recruiting |
| Participants | 240 |
| Est. Completion | 31 Dec 2028 |
| Last Updated | 13 Apr 2026 |
Primary Outcome
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)
Eligibility Criteria
Inclusion Criteria
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.
Trial Sites
Countries
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