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Open Access Highly Accessed Study protocol

A randomised controlled trial of a mindfulness intervention for men with advanced prostate cancer

Suzanne K Chambers1234*, David P Smith45, Martin Berry46, Stephen J Lepore7, Elizabeth Foley8, Samantha Clutton24, Robert McDowall24, Stefano Occhipinti49, Mark Frydenberg10114 and Robert A Gardiner12134

Author Affiliations

1 Griffith Health Institute, Griffith University, 4222, Gold Coast, QLD, Australia

2 Cancer Council Queensland, Brisbane, Australia

3 Prostate Cancer Foundation of Australia, Sydney, Australia

4 Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, Australia

5 Cancer Council NSW, Sydney, Australia

6 University of New South Wales, Sydney, Australia

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

8 Mind Potential, Sydney, Australia

9 School of Psychology, Griffith University, Brisbane, Australia

10 Department of Surgery, Monash University, Melbourne, Australia

11 Royal Melbourne Hospital, Melbourne, Australia

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

13 Department of Urology, Royal Brisbane and Women’s Hospital, Brisbane, Australia

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BMC Cancer 2013, 13:89  doi:10.1186/1471-2407-13-89

Published: 26 February 2013

Abstract

Background

Prostate cancer is the most common male cancer in developed countries, and in Australia approximately one-fifth of men with prostate cancer have advanced disease. By comparison to men with localised prostate cancer, men with advanced disease report higher levels of psychological distress; poorer quality of life; and have an increased risk of suicide. To date no psychological intervention research specifically targeting men with advanced prostate cancer has been reported. In this paper we present the protocol of a current randomised controlled trial to assess the effectiveness of a professionally-led mindfulness-based cognitive therapy (MBCT) group intervention to improve psychological well-being in men with advanced prostate cancer.

Methods/design

Ninety-five men per condition (190 men in total) will be recruited through clinicians in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and in major treatment centres in Queensland, New South Wales, Victoria and Western Australia. Patients are randomised to: (1) tele-based MBCT intervention or (2) patient education. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment, and at 3, 6, and 9 months after recruitment and intervention commencement. Engagement with the principles of mindfulness and adherence to practice will be included as potential mediators of intervention effect. Primary outcomes are anxiety, depression and cancer-specific distress. Secondary outcomes are health-related quality of life (QoL) and benefit finding. Disease variables (e.g. cancer grade, stage) will be assessed through medical records.

Discussion

This study will address a critical but as yet unanswered research question: to identify an effective way to reduce psychological distress; and improve the quality of life for men with advanced prostate cancer.

Trial registration

http://ACTRN12612000306819 webcite

Keywords:
Prostate cancer; Randomised controlled trial (RCT); Supportive care; Mental health; Psychological distress; Quality of life; Health outcomes