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Open Access Highly Accessed Study protocol

Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer

Suzanne K Chambers12*, Robert U Newton3, Afaf Girgis14, Lisa Nielsen2, Stephen Lepore5, Cathrine Mihalopoulos6, RA Gardiner78, Daniel A Galvão3 and Stefano Occhipinti19

Author Affiliations

1 Griffith Health Institute, Griffith University, Gold Coast, Australia

2 Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia

3 Edith Cowan University Health and Wellness Institute, Edith Cowan University, Perth, Australia

4 Ingham Institute, South Western Sydney Clinical School, University of NSW, Sydney, Australia

5 Department of Public Health, Temple University, Philadelphia, USA

6 Deakin Health Economics, Deakin University, Melbourne, Australia

7 University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia

8 Department of Urology, Royal Brisbane and Women's Hospital, Brisbane, Australia

9 School of Psychology, Griffith University, Brisbane, Australia

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BMC Cancer 2011, 11:317  doi:10.1186/1471-2407-11-317

Published: 27 July 2011

Abstract

Background

Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity.

Methods/design

A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial.

Discussion

This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention.

Trial Registration

ACTRN12611000392965