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

NCT06710548 · Dana-Farber Cancer Institute
In plain English

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Official title
Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
About this study
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
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.
Study design
Enrollment target: 240 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-17
Estimated completion: 2029-01-31
Last updated: 2026-04-13
Interventions
Behavioral: REVITALIZE InterventionBehavioral: Educational Materials
Primary outcomes
  • Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2) (20 weeks)
Sponsor
Dana-Farber Cancer Institute · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactHannah Park, BS · contact · revitalize@dfci.harvard.edu · 857.215.4936
ContactIrene Wang, MPH · contact · revitalize@dfci.harvard.edu · 617.582.7238
InvestigatorAlexi A Wright, MD, MPH · principal_investigator, Dana-Farber Cancer Institute
InvestigatorJoanna J Arch, PhD · principal_investigator, University of Colorado, Boulder
All locations (6)
University of Colorado Cancer Center-AnschutzRecruiting
Aurora, Colorado, United States
University of Colorado BoulderRecruiting
Boulder, Colorado, United States
Massachusetts General Hospital-Cancer CenterRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Duke Cancer CenterRecruiting
Durham, North Carolina, United States
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors · TrialPath