Lung cancer rehabilitation and immunotherapy: a pilot randomised controlled trial.

The current usual care for people with lung cancer receiving immunotherapy treatment at the recruitment site does not routinely involve referral for rehabilitation services. As part of usual care all participants receive usual care medical services and support from a nurse coordinator. In addition to usual care, intervention participants will receive a 12-week co-designed rehabilitation program. All intervention participants will attend an initial individual appointment (60-minutes) with a physiotherapist at PMCC or via telehealth. During this appointment the physiotherapist will screen for the need for referral to nutrition and psychology using validated screening questionnaires (Malnutrition Screening Tool [MST] and Patient Health Questionnaire-4 item [PHQ-4]). The MST and PHQ-4 are valid and reliable tools, with scores ranging from 0-5 and 0-12 respectively, and are used to screen for risk of malnutrition and anxiety or depression. Usual care referrals to these disciplines will be made if participants score >3 on either of these tools (indicating they are at risk of malnutrition or anxiety/depression). If participants agree to a psychology referral being made they will be given the option of this occurring by the physiotherapist making the referral to the psychology service at Peter Mac or seeing their GP for a Mental Health Care Plan and referral. During the initial appointment intervention participants will be prescribed and will complete an aerobic (e.g., treadmill walking, stationary cycling, marching/running on the spot) and strength (functional [e.g., squats, heel raises] or upper limb exercises with resistance bands] exercise program. Exercise prescription will be individualized and progressive, taking into account baseline assessment findings and previous exercise experiences and aim to work towards achieving the exercise recommendations for people with cancer of performing 150 minutes of aerobic exercise and 2-3 strength training sessions per week. Exercise will be initially prescribed at a moderate-intensity ('moderate' to 'somewhat hard' 3-4 on the Modified Borg Scale) Following the initial appointment participants will be offered supervised group exercise classes (60 minutes for exercise and every second session an additional 30 minutes for education and building social connections), twice weekly for 12 weeks and can choose to attend either in-person, centre-based or telehealth classes. Telehealth classes will use the usual care PMCC platform (HealthDirect) and Zoom. Zoom maintains several robust security standards to maintain privacy and security. Participants will be provided with PMCC usual care resources and supported by trial staff to use telehealth. Participants will also be prescribed a moderate-intensity home walking program and encouraged to complete this, commencing at a minimum of 10 minutes, on up to 3 non-class days. A second individual face-to-face or telehealth session with the physiotherapist will be offered to participants at approximately 6 weeks to assess that exercises are being performed optimally. Aerobic exercise (continuous and interval) will include treadmill walking or cycling (centre-based) or marching/running on the spot (telehealth). Initial exercise prescription will be individualized (e.g., based on 80% of the baseline six-minute walk test speed). Exercise intensity for each participant will be guided using a modified Borg Scale for perceived exertion/breathlessness (scale 0-10). At program commencement, the aim is for exercise to be performed in the range of 3-4 (‘moderate’ to ‘somewhat hard’ level of exertion). The resistance exercise package will incorporate upper and lower limb exercises performed using exercise equipment in the centre. Participants will be provided with colour coded elastic energy from Therabands® (elastic resistance bands) to perform strength exercises in telehealth sessions. Resistance training will be prescribed individually to approximate 80% of the 10-repetition maximum (the weight that can be lifted 10 times whilst maintaining the correct technique). The exercise band that requires them to exert moderate force but with which they can maintain control throughout the exercises will be used to commence. Functional exercises will also be included to assist in strength training (e.g., step ups, sit to stand from a chair). Participants will perform 2 sets of 8-10 reps initially at moderate intensity (3-4 on the Modified Borg Scale). Programs will be individually progressed according to American College of Sports Medicine guidelines. Behaviour change strategies to increase and sustain new exercise behaviours will be incorporated into the intervention, including action plan development, goal setting, and identification of barriers and enablers to exercising. Participants will be provided with an activity monitor (such as a Fitbit device) or use their own device to monitor their daily step counts. The global positioning system (GPS) function will be turned off. Participants will be educated regarding the safety and benefits of exercise for people with cancer and guided to use the Borg rating of perceived exertion to monitor their exercise intensity. A paper exercise diary will be provided for participants to track prescribed and performed unsupervised home exercise. Additional educational material comprises existing resources which are publicly available regarding management of cancer-related fatigue, eating well, managing breathlessness, side effects of immunotherapy and mental and emotional health. These will be available in printed format and as electronic links available from the study website. At the completion of the 12-week program, participants will be encouraged to continue exercising in their local communities. To facilitate this transition the intervention physiotherapist will provide monthly telehealth (video or telephone dependent on participant preference) 15-30-minute individual appointments for three months to review progress, modify exercise programs as required and link participants with community resources as needed.