RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-17
Study Completion:2029-09-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06710548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).
  2. * Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.
  3. * English-speaking.
  4. * Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.
  5. * ECOG performance status of 0-2.
  6. * Willing to use a wireless pill bottle for PARP inhibitor medication.
  1. * Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.
  2. * 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.
  3. * 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.
  4. * Inability to complete the first questionnaire within one week of consent.

Contacts and Locations

Study Contact

Catherine Howard, BS
CONTACT
617.632.5747
revitalize@dfci.harvard.edu
Irene Wang, MPH
CONTACT
617.582.7238
revitalize@dfci.harvard.edu

Principal Investigator

Alexi A Wright, MD, MPH
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Alexi A Wright, MD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17
Study Completion Date2029-09-28

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2029-09-28

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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