Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
University of Colorado Cancer Center-Anschutz
RECRUITING
Aurora
University of Colorado Boulder
RECRUITING
Boulder
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital-Cancer Center
RECRUITING
Boston
North Carolina
Duke Cancer Center
RECRUITING
Durham
Contact Information
Primary
Hannah Park, BS
revitalize@dfci.harvard.edu
857.215.4936
Backup
Irene Wang, MPH
revitalize@dfci.harvard.edu
617.582.7238
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 240
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov