Pilot randomized trial of a telehealth intervention for women with advanced ovarian cancer and PARP inhibitor-related fatigue.

Abstract

e24122 Background: Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed the treatment of advanced ovarian cancer and are increasingly used in other cancers. However, PARPi cause significant fatigue in nearly half of patients. Psychosocial interventions have shown promise for treating cancer-related fatigue, but there is limited evidence for use in patients with advanced cancers. Moreover, most fatigue interventions have been delivered in person over many sessions, limiting their accessibility and scalability. Methods: We conducted a pilot randomized trial of REVITALIZE, a 6-session telehealth intervention developed and refined by our group, compared with enhanced usual care among 35 fatigued patients with advanced or recurrent ovarian cancer on PARPi at two sites, Dana-Farber Cancer Institute and University of Pennsylvania. REVITALIZE was based on acceptance and commitment-based behavioral therapy and addressed modifiable contributors to PARPi-related fatigue. The trial tested the feasibility, acceptability, and preliminary efficacy of REVITALIZE through 3-month follow-up. Exit interviews were conducted with all REVITALIZE patients. Results: Among 35 participants (mean age=62.5 years, 83% stage III/IV disease, 46% first-line maintenance therapy), the trial met or exceeded its acceptability and feasibility goals. Exit interviews further indicated high acceptability. Relative to enhanced usual care, REVITALIZE significantly reduced fatigue interference at 12-week follow-up (Cohen’s d=.94, p=.008) and fatigue severity (d=.54, p=.049), while improving current fatigue levels (d=.62, p=0.04). REVITALIZE participants also reported improved fatigue self-efficacy, fatigue catastrophizing, depression, anxiety, and quality of life (ds=.60-.86). REVITALIZE participants were also numerically less likely to experience PARPi dose reductions compared with enhanced usual care (7% vs. 17%), and less likely to have dose delays (7% vs. 22%). Conclusions: Among fatigued adults with advanced ovarian cancer on PARPi, a brief telehealth intervention based on acceptance and commitment therapy showed strong feasibility, acceptability, and preliminary efficacy with improvements in fatigue, anxiety, depression, and quality of life outcomes. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation in patients with advanced cancers with PARPi-related fatigue. The study is supported by the National Comprehensive Cancer Network (NCCN) through a grant provided by AstraZeneca. Neither NCCN or AstraZeneca are the sponsors of this study. Clinical trial information: NCT04525183 .