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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06710548
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Fatigue Related to Cancer Treatment
  • Fatigue in Cancer Survivors
  • Ovarian Cancer
  • PARP Inhibitor
  • Primary Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REVITALIZE Intervention — BEHAVIORAL
    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 — BEHAVIORAL
    The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute

Study Details

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

Key Dates

Start date
Mar 17, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2) [ Time Frame: 20 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer Center-AnschutzAuroraColorado80045
Evamaria Bravo, MS
[email protected]
303-724-0131
Carolyn Lefkowits, MD, MPH, MS (PRINCIPAL_INVESTIGATOR)
University of Colorado BoulderBoulderColorado80309
Madeline Nealis, MPH
[email protected]
720-515-9461
Sarah Genung, BA MSc
[email protected]
720-515-9461
Joanna J Arch, PhD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02115
Page Widick, MD
[email protected]
617-667-2100
Dana-Farber Cancer InstituteBostonMassachusetts02215
Alexi Wright, MD, MPH
[email protected]
617-632-2334
Alexi Wright, MD, MPH (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital-Cancer CenterBostonMassachusetts02114
Richard Penson, MBBS
[email protected]
617-724-4800
Duke Cancer CenterDurhamNorth Carolina27710
Amelia Scott
[email protected]
919-613-4584
Laura Havrilesky, MD, MHSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Colorado Cancer Center-Anschutz· Aurora, COUniversity of Colorado Boulder· Boulder, COBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital-Cancer Center· Boston, MADuke Cancer Center· Durham, NC

Related Studies