REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
NCT ID: NCT06710548
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2025-03-17
2029-01-31
Brief Summary
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The name of the study groups in this research study are:
1. REVITALIZE
2. Educational Materials
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ARM 1: REVITALIZE Intervention
120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following:
1. Questionnaire upon enrollment.
2. Use of a wireless pill bottle for PARP inhibitor medication.
3. Eight weekly one-on-one intervention sessions with a coach via Zoom.
4. Two booster sessions to reinforce intervention with a coach via Zoom.
5. Questionnaires at 8, 13, 20, and 28 weeks.
REVITALIZE Intervention
A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via the Zoom platform and will either be videotaped or audiotaped.
ARM 2: Educational Materials
120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following:
1. Questionnaire upon enrollment.
2. Use of wireless pill bottle for PARP inhibitor medication.
3. Educational information on cancer survivorship, including management of fatigue.
4. Questionnaires at 8, 13, 20, and 28 weeks.
Educational Materials
The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute
Interventions
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REVITALIZE Intervention
A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via the Zoom platform and will either be videotaped or audiotaped.
Educational Materials
The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Alexi A. Wright, MD
Principal Investigator
Principal Investigators
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Alexi A Wright, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Joanna J Arch, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Locations
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University of Colorado Cancer Center-Anschutz
Aurora, Colorado, United States
University of Colorado Boulder
Boulder, Colorado, United States
Massachusetts General Hospital-Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Duke Cancer Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-105
Identifier Type: -
Identifier Source: org_study_id