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

Dana-Farber Cancer Institute

Status: Enrolling

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

Treatments: Behavioral: Educational Materials; Behavioral: REVITALIZE Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06710548

24-105

R01CA289547 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

ARM 1: REVITALIZE Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: REVITALIZE Intervention

ARM 2: Educational Materials

Active Comparator group

Description:

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.

Treatment:

Behavioral: Educational Materials