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NCT06710548 | RECRUITING | Ovarian Cancer

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

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Alexi A. Wright, MD

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

Condition or disease

Ovarian Cancer

Advanced Ovarian Carcinoma

Fallopian Tube Carcinoma

Primary Peritoneal Cancer

PARP Inhibitor

Fatigue Related to Cancer Treatment

Fatigue in Cancer Survivors

Intervention/treatment

REVITALIZE Intervention

Educational Materials

Phase

NA

Detailed Description:

This Phase 3 randomized controlled trial will evaluate the effect of a brief, acceptance-based tele-health intervention (REVITALIZE) vs. educational materials in participants with ovarian cancer who are taking poly-ADP ribose polymerase (PARP) inhibitors. Participants will be randomized into one of two study groups: 1) REVITALIZE or 2) Educational Materials. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, using a wireless pill bottle, and completing questionnaires. Participation in this research study is expected to last about 7 months. It is expected about 240 people will take part in this research study. The National Cancer Institute is supporting this research by providing funding.

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
Actual Study Start Date : 2025-03-17
Estimated Primary Completion Date : 2028-10-31
Estimated Study Completion Date : 2029-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors

Location Details

NCT06710548

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215