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

Official title

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

Overview

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

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.

Interventions

• Behavioral REVITALIZE Intervention
  A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via t
• Behavioral Educational Materials
  The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute

Primary outcome measures

• Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2) [Time frame: 20 weeks]

Secondary outcome measures (12)

• Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2) [Time frame: 28 weeks]
• Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2) [Time frame: 20 weeks]
• Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2) [Time frame: 28 weeks]
• Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2) [Time frame: 20 weeks]
• Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2) [Time frame: 28 weeks]
• Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2) [Time frame: 20 weeks]
• Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2) [Time frame: 28 weeks]
• Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2) [Time frame: 8 weeks]
• Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2) [Time frame: 13 weeks]
• Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2) [Time frame: 20 weeks]
• Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2) [Time frame: 20 weeks]
• Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2) [Time frame: 28 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 6 centers

• University of Colorado Cancer Center-Anschutz — Aurora
• University of Colorado Boulder — Boulder
• Massachusetts General Hospital-Cancer Center — Boston
• Beth Israel Deaconess Medical Center — Boston
• Dana-Farber Cancer Institute — Boston
• Duke Cancer Center — Durham

Publications

• Arch JJ, Uno H, Poort H, Slivjak E, Nealis MS, Park H, Wang I, Genung SR, Cronin A, Andorsky DJ, Havrilesky LJ, Penson RT, Mazina V, Widick P, Lefkowits C, Wright AA. Randomized clinical trial of an Acceptance and Commitment Therapy telehealth intervention ('REVITALIZE') to reduce fatigue interference in women with advanced ovarian cancer on PARP inhibitors: study protocol. BMC Cancer. 2026 Apr 2; PMID 41928160

Identifiers

NCT: NCT06710548 · 24-105 · R01CA289547

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗