Revitalize Program for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Alexi A. Wright, MD, MPH - Dana-Farber ...

Overseen byAlexi A Wright, MD, MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for adults with ovarian cancer who are currently taking PARP inhibitors and experiencing fatigue. Participants should be willing to undergo a psychosocial intervention aimed at reducing fatigue.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I speak English.

My fatigue level is high, scoring 4 or more.

+2 more

Exclusion Criteria

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

I have a health condition, not related to PARP inhibitors, that could cause fatigue.

Participant Groups

The study is testing the effectiveness of the REVITALIZE intervention against Enhanced Usual Care (EUC) in reducing fatigue for ovarian cancer patients on PARP inhibitors.

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM 1: REVITALIZE InterventionExperimental Treatment1 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.

Group II: ARM 2: Educational MaterialsActive Control1 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 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.