NCT04525183

REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities.

Detailed description

This is a two-arm, multicenter pilot randomized controlled trial to compare the feasibility, acceptability, and preliminary efficacy of REVITALIZE, a 6-week Acceptance and Commitment Therapy (ACT) telehealth intervention vs. enhanced usual care (EUC) in fatigued patients with ovarian cancer on maintenance PARPi. The intervention is called REVITALIZE, and it is a structured, skills-based intervention for providing support, knowledge, and skills for coping with fatigue. This type of intervention has been used in other studies to treat symptoms such as pain, migraines, or worry. This research is being done to develop this program at the Dana-Farber Cancer Institute and the University of Pennsylvania's Abramson Cancer Center, and to get patient feedback on the telehealth intervention to improve it for a future study. The study is also making a preliminary determinations as to whether REVITALIZE does improve psychological flexibility and fatigue-related interference and reduces fatigue, psychological distress, and fear of cancer recurrence, while improving overall quality of life (QOL). The study will pre-pilot the REVITALIZE intervention in up to 5 patients at the Dana-Farber Cancer Institute (DFCI). This run-in phase serves to test and refine the newly developed 6-week ACT intervention in a smaller sample size prior to initiating the randomized control trial (RCT) portion of the study. After the ACT intervention has been tested and refined, the study will enroll and randomize 40 fatigued patients with advanced ovarian cancer on maintenance PARPi at Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of Pennsylvania. Participants will be randomized to receive either a 6-week ACT intervention or enhanced usual care (educational materials). The study anticipates enrolling approximately 20 patients at each site, and 20 patients will be enrolled to each study arm. The ACT intervention will be delivered by masters' level psychologists at The University of Colorado Boulder. It is expected participants will remain in the study for the duration of the intervention and follow-up assessments, which is approximately 3 months. The Funding Organization for this study is the National Comprehensive Cancer Network (NCCN) and the Research Funding Provider is AstraZeneca.

Conditions

• Ovarian Cancer
• Fatigue
• Coping Behavior
• Coping Skills

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced Usual Care (EOC)	Educational materials
BEHAVIORAL	REVITALIZE ACT Intervention	Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-08-09
• Completion: 2022-08-09
• First posted: 2020-08-25
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

2 sites across 1 country: United States