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

INTERVENTION: 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 im CONDITION: Cancer ‐ Malignant melanoma Melanoma;Immunotherapy;Fatigue; ; Melanoma ; Immunotherapy ; Fatigue Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation PRIMARY OUTCOME: This feasibility study's primary objective is to estimate the recruitment rate and appraise reasons for ineligibility.; ; This, along with other quantitative feasibility outcomes will be measured against pre‐specified feasibility criteria. For the primary outcome variable this is that: on average, we will recruit 10 participants per month for three months. Reasons for ineligbility will be documented as part of screening for reporting against this outcome.; [12 weeks post trial commencement] SECONDARY OUTCOME: To assess the acceptability and appropriateness of study measures. ; ; This will be assessed through investigation of completeness of Patient Reported Outcome Measures and through the patient qualitative interview. ; ; Patient reported outcome measures comprise: ; Functional Assessment of Chronic Illness Therapy (FACIT‐F) ; Brief Fatigue Inventory (BFI) ; PROMIS Ability to Participate in Social Roles and Activities—Short Form 6a ; Short Form 36 health survey questionnaire (SF‐36) ; Edmonton Symptom Assessment Scale (ESAS) ; The Godin Leisure‐time Physical Activity Questionnaire (GLTEQ)[24 weeks post trial commencement] To assess the practicability and utility of additional blood collection. ; ; Barriers or issues with blood collection will be recorded. [24 weeks post trial commencement] To assess the retention of participants at 16 and 24 weeks. ; ; ; Exercise physiologists will record each exercise‐related adverse event per patient self‐report (type, duration, severity) as they occur. ; ; Common exercise‐related adverse events comprise sore muscles or feelings of fatigue. [24 weeks post trial commencement ; This will be assessed through data recording patients who withdraw or are lost to follow‐up.[at the conclusion of the trial all data regarding withdrawal or lost to follow‐up will be analysed] To determine the number and type of exercise‐related adverse events. ; ] To investigate adherence to a personalised, prescribed exercise intervention. ; ; Exercise physiologists will record adherence at each face‐to‐face and telephone consultation on a three‐point likert scale according to % of activities completed (good = >80%; moderate =50‐80%; poor <50%). This is recorded from both the participants point of view and the EP's perspective. The Godin Leisure‐time Activity Level Questionnaire will also be used to monitor physical activity throughout the duration of the trial.[Recorded throughout intervention delivery (12wks)] To investigate adherence to iMove consultations with the exercise physiologist (EP) (face to face and via telephone) . ; ; This will be measured against pre‐specified feasibility criteria comprising: ; ; At least 75% of participants randomised to iMove will attend at least 3 of the first 4 face‐to‐face consultations ; and ; At least 75% of participants randomised to iMove will attend at least 3 of the first 4 telephone consultations[24 weeks post trial commencement] To investigate the acceptability of a personalised, prescribed exercise intervention. ; ; This will be assessed using a qualitative interviews. Intervention participants will be interviewed at 12 weeks (post intervention conclusion) and Exercise Physiologists will be interviewed at the conclusion of the trial. [12 weeks (intervention participants) ; 24 weeks trial commencement] To investigate the acceptability of the Exercise Physiology consultation sessions. ; ; This will be assessed using a qualitative interviews. Intervention participants will be interviewed at 12 weeks (post intervention conclusion) and Exercise Physiologists will be interviewed at the conclusion of the trial. [12 weeks (intervention participants) ; 24 weeks post trial commencement] To investigate the potential impact of iMove on fatigue and other patient‐reported outcomes, as well as objective measures of fitness. ; ; As this is a feasibility trial, it is not adequately powered to investigate between group differences. Preliminary comparisons to assess potential impact will be conducted on: ; Fatigue (BFI; FACIT‐F) ; Quality of Life (SF‐36) ; Role functioning (PROMIS Ability to participate in Social Roles and Activities Short Form 6a) ; Symptoms (Edmonton Symptom Assessment Scale) ; Physical Activity (Godin Leisure‐time Physical Acitivity Questionnaire) ; ; Objective measures of fitness which will be reviewed include: ; Six‐minute walk test ; Arm curl test ; Chair stand test ; The Australia‐modified Karnofsky Performance Scale (AKPS) ; ; [Measured at baseline (week 1); week 7, week 13, week 16 and week 24] INCLUSION CRITERIA: • Aged 18 years or older • Diagnosis of stage IV Melanoma • Scheduled to commence receiving single agent Ipilimumab, Nivolumab or Pembrolizumab; or combination Ipilimumab and Nivolumab immunotherapy, and have not yet had their second infusion • Able to speak and read English • Deemed suitable to take part in an exercise intervention by their treating clinician • Access to a smartphone