Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial

Lara Edbrooke; Sanchia Aranda; Catherine Granger; Christine McDonald; Mei Krishnasamy; Linda Mileshkin; Louis Irving; Sabine Braat; Ross Clark; Ian Gordon; Linda Denehy

doi:10.1186/s12885-017-3651-4

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Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial

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Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial

Lara Edbrooke, Sanchia Aranda, Catherine Granger, Christine McDonald, Mei Krishnasamy, Linda Mileshkin, Louis Irving, Sabine Braat, Ross Clark, Ian Gordon, …

BMC Cancer, Vol.17, 663

2017

DOI: https://doi.org/10.1186/s12885-017-3651-4

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Abstract

non-small cell lung cancer

home-based exercise

symptom control

supportive care

physical function

Background: 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%. 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. Methods: This 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. Discussion: There 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.

Details

Title: Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial
Authors: Lara Edbrooke (Author) - University of Melbourne
Sanchia Aranda (Author) - Cancer Council Australia
Catherine Granger (Author) - University of Melbourne
Christine McDonald (Author) - Melbourne Health
Mei Krishnasamy (Author) - University of Melbourne
Linda Mileshkin (Author) - The Peter MacCallum Cancer Centre
Louis Irving (Author) - Melbourne Health
Sabine Braat (Author) - University of Melbourne
Ross Clark (Author) - University of the Sunshine Coast - Faculty of Science, Health, Education and Engineering
Ian Gordon (Author) - University of Melbourne
Linda Denehy (Author) - University of Melbourne
Publication details: BMC Cancer, Vol.17, 663; 12
Publisher: BioMed Central Ltd.
Date published: 2017
DOI: 10.1186/s12885-017-3651-4
ISSN: 1471-2407
Copyright note: Copyright © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Organisation Unit: University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy; School of Health and Behavioural Sciences - Legacy; School of Health - Public Health
Language: English
Record Identifier: 99451291102621
Output Type: Journal article

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