In the era of precision oncology, patients with advanced cancer are often living longer but are enduring years of fatiguing treatment. Fatigue is among the most common, chronic, and under-addressed side effects of advanced cancer treatment, and can lead to dose reductions, treatment interruptions, and discontinuation. Oral PolyADP-ribose polymerase (PARP) inhibitors have revolutionized the treatment of advanced ovarian cancer but are often accompanied by clinically-significant fatigue, and evidence-based treatments to cope with this side effect remain limited. A pilot trial suggests that telehealth acceptance and commitment therapy (ACT), a variant of cognitive behavioral therapy based on acceptance, mindfulness, and personal values, has potential to improve fatigue interference (i.e. disrupting activity and quality of life) among ovarian cancer patients on maintenance PARP inhibitors. This study protocol describes a fully-powered randomized controlled trial (RCT) of an innovative, remotely-delivered ACT intervention (‘REVITALIZE’) that aims to improve fatigue outcomes and PARP inhibitor adherence. This two-armed, prospective RCT randomizes 240 adults with advanced ovarian cancer who report moderate to severe fatigue while on PARP inhibitors 1:1 to either REVITALIZE or education-enhanced usual care. The REVITALIZE intervention includes eight weekly one-hour individual sessions delivered via videoconference, plus two booster sessions at one- and two-month intervals thereafter. Participants, recruited from both academic and community cancer care sites across three U.S. regions, will complete assessments at baseline, mid-intervention, post-intervention, and 20 and 28-week follow-up (FU). The primary patient-reported outcome is change in fatigue interference from baseline to week 20 (FU1). Secondary patient-reported outcomes include fatigue severity, catastrophizing, self-efficacy, and quality of life. The primary behavioral outcome is monthly PARP inhibitor adherence, assessed by wireless medication adherence monitors; dose interruptions, reductions, and persistence will also be evaluated using adherence monitors and medical chart review. This paper describes a RCT that will evaluate the efficacy of the telehealth REVITALIZE intervention for improving fatigue-related outcomes and medication adherence among adults with advanced ovarian cancer taking PARP inhibitors. Findings will inform clinical practice and supportive care for adults with advanced ovarian cancer receiving treatments that cause fatigue. Clinicaltrials.gov NCT06710548 on November 29, 2024.
Arch et al. (Thu,) studied this question.
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