Reducing fatigue in adults with ovarian cancer on PARP inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a tele-health intervention called REVITALIZE in reducing fatigue and its impact on daily life for adults with ovarian cancer who are receiving PARP inhibitors. Participants will be randomly assigned to either the REVITALIZE intervention or to receive educational materials. The study will involve screening for eligibility, using a wireless pill bottle for medication adherence, and completing questionnaires over a period of approximately 7 months. The trial aims to enroll around 240 participants and is supported by the National Cancer Institute.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Colorado Cancer Center-Anschutz
  Aurora, Colorado, United States Recruiting
• University of Colorado Boulder
  Boulder, Colorado, United States Recruiting
• Massachusetts General Hospital-Cancer Center
  Boston, Massachusetts, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Duke Cancer Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Alexi A Wright, MD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Hannah Park, BS
• Email: revitalize@dfci.harvard.edu
• Phone: 857.215.4936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.