I-Move: A randomised controlled pilot trial of a personalised, semi-supervised exercise intervention to reduce fatigue for patients receiving immunotherapy for stage IV Melanoma

Participants randomised to receive the intervention will be prescribed a personalised, 12-week exercise program. The program will be run on an individual rather than group basis so each participant can commence the exercise program at the start of their immunotherapy regime The intervention will be delivered by an accredited allied health Exercise Physiologist (EP) based at Peter Mac. EP’s at Peter Mac are specifically trained in the prescription of personalised exercise interventions for people with cancer, and in managing safety of patients undertaking exercise while receiving cancer treatment. Each individual program will be designed by the EP, and will take into consideration: • relevant demographic and clinical characteristics (e.g. disease, age etc.) • physical suitability • any safety considerations • current exercise activities including work, home and leisure activities As per the COSA guidelines for exercise in cancer care, the exercise prescription will allow patients to work towards and then maintain participation in: •at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise each week; and •two to three resistance exercise sessions each week involving moderate-to vigorous-intensity exercises targeting the major muscle groups The EP will use the smartphone application: Physitrack to provide each participant with their exercise activity program. Patients can view the app at home to watch videos on how to do specific exercises, and to log activities completed. The app is designed so that the EP can create and amend the exercise program remotely. The participant can only view and log activity compliance, but not change the prescribed exercise program. Physitrack is free for patients to download. EP guidance that will be provided as part of the exercise intervention will comprise: •4 x face-to-face 1hr sessions at Peter Mac every three weeks, to coincide with immunotherapy infusion appointments, •4 x 15min telephone supervision sessions scheduled for the week after the face-to-face session •1x final 1hr face-to-face session at the conclusion of the exercise intervention to discuss ongoing physical activity and community resources patients can access close to home. During both telephone and face-to-face sessions, the EP will monitor exercise progress, update exercise activities if required (for example increase or reduce intensity depending on the patient’s current capacity) and monitor safety (discussed further in section 4.0). There will be an option for the EP to add additional telephone sessions on the week between telephone and face-to-face contact if the participant requires additional monitoring or assistance.