Abstract
PURPOSE: National guidelines recommend fitness and mind-body exercise to reduce cancer-related fatigue, but substantial barriers to implementation exist. Virtual programs offer a scalable approach to address this gap. This study aims to evaluate the efficacy of a virtual fitness and mind-body exercise program (Integrative Medicine at Home [IM@Home]) in reducing fatigue in patients undergoing radiation therapy (RT) for breast cancer. METHODS AND MATERIALS: A prospective randomized controlled patient-reported outcome basket clinical trial was conducted. Patients undergoing breast RT who reported moderate or greater fatigue were randomly assigned 1:1 ratio to either IM@Home, which provided live virtual fitness and mind-body exercise classes, or enhanced usual care (EUC). The primary outcome, fatigue, was measured using the total Brief Fatigue Inventory, a composite score including severity and impact on daily functioning, weekly over 12 weeks. Secondary outcomes included the Insomnia Severity Index, Edmonton Symptom Assessment Scale, and Hospital Anxiety and Depression Scale collected every 4 weeks. Statistical analysis included linear mixed models to compare group differences over time using a statistical significance threshold of P < .05. RESULTS: Among 73 enrolled patients, 35 were randomly assigned to IM@Home and 38 to EUC. At week 12, patients in the IM@Home group had significantly less fatigue compared to those in the EUC group (2.06 vs 2.79, P = .009). Compared to EUC, patients in the IM@Home group showed greater reductions in insomnia (P = .005), symptom distress (P = .013), and depression (P = .04), but not anxiety (P = .14). CONCLUSIONS: The IM@Home program significantly reduced fatigue and comorbid symptoms among women with breast cancer undergoing RT. Future research is needed to confirm these findings, explore mechanisms of the observed benefit, and evaluate scalability as well as barriers and facilitators to implementation.