The PREVENT study: Does PRE-habilitation improVe pErformance status in uN-resectable stage III non-small cell lung cancer (NSCLC) patients undergoing chemo-radioTherapy? - A pilot study

INTERVENTION: Sessions will be individual and face‐to‐face, which will be held at the physiotherapy clinic at the Ballarat Regional Integrated Cancer Centre (BRICC) or Queen Elizabeth Centre. Each 50‐minute mixed exercise session will consist of: ‐ 5‐minute warm‐up on stationary bike at self‐selected pace. ‐ 20 minutes of aerobic exercise (i.e., treadmill jogging/running and cycling). ‐ 10 minutes of resistance exercise (e.g., bench press, leg press, etc.). ‐ 10 minutes of structured, assisted stretching (i.e., upper body and lower body stretches). ‐ 5‐minute cool down. The length of the intervention will last the duration of the patient's chemo‐radiation therapy, which will be for a minimum of at least 3 weeks and up to a maximum of 8 weeks. Training progression will be in consecutive 2‐week epochs with increasing intensity determined by participant’s individual heart rate maximum (HRM): ‐ Weeks 1 and 2: 2 x 50 minutes (up to 55% HRM) ‐ Weeks 3 and 4: 3 x 50 minutes (up to 60% HRM) ‐ Weeks 5 and 6: 3 x 50 minutes (up to 65% HRM) ‐ Weeks 7 and 8: 3 x 50 minutes (up to 70% HRM) Adherence to the intervention will be monitored using a session attendance checklist, and individual programming will be guided by proprietary software [goXpro, Sydney, AU (https://www.goxpro.com/optin‐454228331608376497106)]. CONDITION: Cancer ‐ Lung ‐ Non small cell Patients with un‐resectable stage III non‐small cell lung cancer (NSCLC) undergoing chemo‐radiotherapy.; ; Patients with un‐resectable stage III non‐small cell lung cancer (NSCLC) undergoing chemo‐radiotherapy. PRIMARY OUTCOME: Aerobic fitness will be determined by peak oxygen consumption (VO2peak), which will be estimated using a submaximal cardio‐pulmonary exercise test (CPET) performed on an electronically braked cycle ergometer as per guidelines published by the American Heart Association (Balady et al., 2010).[Baseline and 8‐weeks post‐intervention commencement.] Functional capacity will be assessed using the 6‐minute walk test (6MWT), following the guidelines set out by American Thoracic Society (2002).[Baseline and 8‐weeks post‐intervention commencement.] INCLUSION CRITERIA: 1. Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8. 2. No evidence of metastatic disease by whole body PET/CT scan, diagnostic quality CT scan, and brain imaging 3. Have un‐resectable disease, that is amenable to be treated with radical‐intent chemo‐radiotherapy, as decided through a thoracic multidisciplinary meeting. 4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Have adequate pulmonary function test (PFT) as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and the carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value. 6. Fulfill the guideline requirements in the APSS. 7. Have capacity to provide written informed consent for the trial. SECONDARY OUTCOME: Adverse events will be defined as any side effect from the intervention (exercise‐related adverse events), side effect from the patient’s cancer treatment (treatment‐related adverse events), or side effect from the cancer itself (cancer‐related adverse events). These will be reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE; version 5.0) criteria. Information on adverse events will include the type of adverse event, a description of the event, the time and data of the event, and any other relevant information.[Baseline and 8‐weeks post‐intervention commencement.] Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a 14‐item self‐reported questionnaire developed to assess psychological stress in non‐psychiatric patients. [Baseline and 8‐weeks post‐intervention commencement.] Cancer‐specific quality of life (QoL) will be measured using the Functional Assessment of Cancer Therapy‐Lung (FACT‐L) instrument (version 4). The FACT‐L is a 36‐item self‐reported questionnaire designed to measure multidimensional QoL over the previous 7 days for patients diagnosed with lung cancer. [Baseline and 8‐weeks post‐intervention commencement.] Pulmonary function will be determined by the patient’s forced expiratory volume in the first second (FEV1). Patients will be required to undergo a spirometry test.[Baseline and 8‐weeks post‐intervention commencement.] The Eastern Cooperative Oncology Group (ECOG) Performance Status instrument will used to assess how a patient’s disease is progressing and how the disease is affecting the daily living abilities of the patient.[Baseline and 8‐weeks post‐intervention commencement.]