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Open Access Highly Accessed Study protocol

The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

Haryana M Dhillon14, Hidde P van der Ploeg23, Melanie L Bell4, Michael Boyer5, Stephen Clarke67 and Janette Vardy14568*

Author affiliations

1 Centre for Medical Psychology and Evidence-based Decision-making, University of Sydney, Sydney, Australia

2 Sydney School of Public Health, University of Sydney, Sydney, Australia

3 Department of Public and Occupational Health, VU University Medical Center Amsterdam, Amsterdam, The Netherlands

4 Psycho-Oncology Co-Operative Research Group (PoCoG), School of Psychology, Faculty of Science, University of Sydney, Sydney, Australia

5 Sydney Cancer Centre, Sydney, Australia

6 Sydney Medical School, University of Sydney, Sydney, Australia

7 Royal North Shore Hospital, St Leonards, Australia

8 Sydney Cancer Centre, Concord Repatriation General Hospital, Hospital Rd, Concord, NSW, 2137, Australia

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Citation and License

BMC Cancer 2012, 12:572  doi:10.1186/1471-2407-12-572

Published: 5 December 2012

Abstract

Background

People with lung cancer have substantial symptom burden and more unmet needs than the general cancer population. Physical activity (PA) has been shown to positively influence quality of life (QOL), fatigue and daily functioning in the curative treatment of people with breast and colorectal cancers and lung diseases, as well as in palliative settings. A randomised controlled trial (RCT) is needed to determine if lung cancer patients benefit from structured PA intervention. The

    P
hysical
    A
ctivity in
    L
ung Cancer (PAL) trial is designed to evaluate the impact of a 2-month PA intervention on fatigue and QOL in patients with non-resectable lung cancer. Biological mechanisms will also be studied.

Methods/design

A multi-centre RCT with patients randomised to usual care or a 2-month PA programme, involving supervised PA sessions including a behavioural change component and home-based PA. QOL questionnaires, disease and functional status and body composition will be assessed at baseline, 2, 4 and 6 months follow-up. The primary endpoint is comparative levels of fatigue between the 2 arms. Secondary endpoints include: QOL, functional abilities and physical function. Exploratory endpoints include: anxiety, depression, distress, dyspnoea, PA behaviour, fitness, hospitalisations, survival, cytokines and insulin-like growth factor levels.

Discussion

This study will provide high-level evidence of the effect of PA programmes on cancer-related fatigue and QOL in patients with advanced lung cancer. If positive, the study has the potential to change care for people with cancer using a simple, inexpensive intervention to improve their QOL and help them maintain independent function for as long as possible.

Trial registration

Australian New Zealand Clinical Trials Registry No. ACTRN12609000971235

Keywords:
Physical activity; Exercise; Fatigue; Quality of life; Lung cancer