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NCT06710548Recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
26 Nov 2024
Start date
17 Mar 2025
Primary completion date
31 Dec 2028
Lead sponsor
Dana-Farber Cancer Institute
NCT number
NCT06710548

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 17 Mar 2025 to the primary completion date, 31 Dec 2028
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Inability to complete the first questionnaire within one week of consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Colorado Cancer Center Anschutz
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Massachusetts General Hospital Cancer Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Colorado Boulder
Coordinator of this site? Confirm its status
BoulderUnited StatesRecruiting
Duke Cancer Center
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.