Abstract
BackgroundLung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC.MethodsThis multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference.DiscussionThere is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting.Trial registrationThis trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12614001268639: (4/12/14).
Highlights
Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide
The American College of Sports Medicine (ACSM) recommendations for Physical activity (PA) in cancer survivors are in line with current recommendations for the healthy population; avoid sedentary time, and perform at least 150 min of moderateintensity aerobic exercise and two-to-three resistance-training sessions per week [8]
Increased PA is shown to be associated with improved survival, predominantly in breast (13 studies reported a decrease in breast cancer mortality of between 13 and 51% when comparing those in the highest versus lowest PA categories) and colorectal cancers [4]
Summary
Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. Eighty-five percent of all new diagnoses are non-small cell lung cancers (NSCLC) [2]. Several health benefits of increased PA are reported for cancer populations [4,5,6,7]. 82% of UK cancer survivors [11] and 60% of patients with NSCLC do not meet current PA guidelines at diagnosis [12]
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