Distance-based Exercise to preserve Function and prevENt Disability (DEFEND)

Many cancer survivors experience challenges in performing daily activities and loss of work productivity due to the adverse effects of cancer and its treatments, resulting in financial burdens for both individuals and society. These effects are more pronounced in vulnerable groups of cancer survivors, including racial and ethnic minorities, individuals living in rural areas, and individuals of lower socioeconomic status. Exercise is effective for improving physical function and reducing treatment-related side effects, but many cancer survivors are insufficiently active after diagnosis. Given the profound implications of cancer on individual and societal health, it is crucial to address these challenges through the development of scalable, effective exercise interventions accessible to all, including vulnerable populations. Additionally, identifying patients at risk of functional loss as a result of cancer treatment will be essential to ensuring that exercise is directed to the individuals most likely to benefit and that programs are developed for successful implementation in these populations. The overall goals of this U34 Clinical Trials Planning Grant are to further define the population of patients most likely to derive benefit from the incorporation of exercise during cancer treatment, establish the feasibility of enrolling and retaining a diverse patient population to an exercise oncology intervention trial during chemotherapy, successfully implement a technology-enabled exercise program across academic and community oncology practices, and identify facilitators and barriers to the implementation of an exercise intervention trial in key stakeholders. The planning grant will include an assessment of factors associated with a decline in function in individuals enrolled in the American Cancer Society Cancer Prevention Study-3 cohort and single-arm exercise intervention pilot study conducted through the Alliance for Clinical Trials in Oncology NCORP research base. The pilot study will evaluate the feasibility of conducting a virtual aerobic and resistance-training exercise intervention trial in 80 patients at risk of functional decline undergoing chemotherapy in community and academic sites. Feasibility will be defined based on rates of enrollment, diversity of the patient population, retention, and adherence to the exercise program. The exercise intervention program will be delivered centrally by exercise trainers based at DFCI via telehealth sessions accessed through a study-provided cellular-enabled tablet. Key stakeholders, including patients, patient advocates, caregivers, and clinical staff involved in the pilot study will undergo semi-structured interviews focused on facilitators and barriers to the implementation of the exercise intervention. Results of this planning grant will be used to inform the development of a Phase III trial to assess the efficacy of an efficient technology-enabled exercise oncology intervention to prevent the decline in physical function often observed in patients receiving chemotherapy, toward the goal of reducing the number of cancer survivors requiring SSA Disability designation and increasing the capacity for full employment.