Supporting older adults with cancer and their support person through geriatric assessment and remote exercise and education: The SOAR study protocol

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INTRODUCTION: Frail older adults receiving cancer treatment are at heightened risk of adverse outcomes. Despite the known benefits of exercise during cancer treatment to improve well-being, few exercise studies focus on frail older adults receiving cancer treatment and their support person. Geriatric assessment (GA) is often recommended prior to the start of treatment for frail adults with cancer, but combining the GA with a planned exercise regimen remains unexplored. This study aims to determine the feasibility and acceptability of implementing geriatric assessment and management (GAM) in combination with virtual chair-based exercise (CBE) and health education for frail older adults with cancer and their support persons. MATERIALS AND METHODS: This phase 2 randomized controlled trial will include patients aged 70 years and above with a lung, gastrointestinal, or genitourinary cancer referred for first- or second-line chemotherapy, immunotherapy, or targeted therapy. Patients must be frail (≥3 on the Vulnerable Elders Survey), sedentary on the Godin Leisure Time Activity Questionnaire (<90 min of moderate/intense activity per week), have English proficiency with ability to consent, a physician-estimated life expectancy of at least six months, and deemed safe to exercise. Each older adult will be invited to bring a support person to participate in the study. Patients will be randomized 1:1 to GAM combined with online CBE and health education for 12 weeks or waitlist control. Participating support persons will follow the same intervention group. Primary endpoints for feasibility and acceptability will be recruitment rate, retention, adherence, and data collection. Outcome measures include physical activity, function, fatigability, quality of life, treatment toxicity, and unplanned hospital visits. Outcome measures will be used to obtain estimates of the effect size and feasibility analysis needed for designing a phase 3 study. The study will take place at two hospitals in Toronto, Canada. DISCUSSION: This study will investigate the feasibility, acceptability, and obtain preliminary estimates of the outcomes of GAM plus CBE and health education in preventing functional decline and improving quality of life in frail older adults receiving cancer treatment and their support persons. The results will help to design a definitive phase 3 randomized controlled trial. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (Registration Number: NCT05509751).

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