Recruiting

PARP Inhibitors

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06710548

Conditions

Ovarian Cancer

Advanced Ovarian Carcinoma

Fallopian Tube Carcinoma

Primary Peritoneal Cancer

PARP Inhibitor

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REVITALIZE Intervention

Educational Materials

Study Details

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

Conditions

Ovarian Cancer

Advanced Ovarian Carcinoma

Fallopian Tube Carcinoma

Primary Peritoneal Cancer

PARP Inhibitor

Study ID

NCT06710548

Start date

Mar 17, 2025

Status verified date

Apr, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Hannah Park, BS

857.215.4936revitalize@dfci.harvard.edu

Irene Wang, MPH

617.582.7238revitalize@dfci.harvard.edu

Locations

University of Colorado Cancer Center-Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Evamaria Bravo, MS

303-724-0131evamaria.kentbravo@cuanschutz.edu

Principal Investigator:

Carolyn Lefkowits, MD, MPH, MS

University of Colorado Boulder

Recruiting

Boulder, Colorado, United States, 80309

Contacts

Madeline Nealis, MPH

720-515-9461revitalize@colorado.edu

Sarah Genung, BA MSc

720-515-9461revitalize@colorado.edu

Principal Investigator:

Joanna J Arch, PhD

Massachusetts General Hospital-Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Richard Penson, MBBS

617-724-4800rpenson@mgb.org

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Page Widick, MD

617-667-2100pwidick@bidmc.harvard.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alexi Wright, MD, MPH

617-632-2334Alexi_Wright@dfci.harvard.edu

Principal Investigator:

Alexi Wright, MD, MPH

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Amelia Scott

919-613-4584amelia.lorenzo@duke.edu

Principal Investigator:

Laura Havrilesky, MD, MHSc

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Ovarian Cancer
  • Advanced Ovarian Carcinoma
  • Advanced Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • Fatigue related to cancer treatment
  • Fatigue in Cancer Survivors
  • PARP inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-04-13.