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
2 other identifiers
interventional
240
1 country
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable ovarian-cancer
Started Mar 2025
Typical duration for not_applicable ovarian-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2024
CompletedFirst Posted
Study publicly available on registry
November 29, 2024
CompletedStudy Start
First participant enrolled
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
April 13, 2026
April 1, 2026
3.8 years
November 26, 2024
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)
Assessed by the 7-item Fatigue Interference subscale of the Fatigue Symptom Inventory (FSI). Items are rated on an 11-point scale (0 = no interference; 10 = extreme interference), with a total scores range of 0 to 70 with the higher score representing greater fatigue interference with daily life. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.
20 weeks
Secondary Outcomes (28)
Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2)
28 weeks
Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2)
20 weeks
Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2)
28 weeks
Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2)
20 weeks
Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2)
28 weeks
- +23 more secondary outcomes
Study Arms (2)
ARM 1: REVITALIZE Intervention
EXPERIMENTAL120 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.
ARM 2: Educational Materials
ACTIVE COMPARATOR120 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.
Interventions
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.
The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Dana-Farber Cancer Institutelead
Study Sites (6)
University of Colorado Cancer Center-Anschutz
Aurora, Colorado, 80045, United States
University of Colorado Boulder
Boulder, Colorado, 80309, United States
Massachusetts General Hospital-Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexi A Wright, MD, MPH
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Joanna J Arch, PhD
University of Colorado, Boulder
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 26, 2024
First Posted
November 29, 2024
Study Start
March 17, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
January 31, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.