Study protocol

ProsCan for Men: Randomised controlled trial of a decision support intervention for men with localised prostate cancer

Suzanne K Chambers^1,2,3 , Megan Ferguson¹ , RA Gardiner^3,4 , David Nicol⁵ , Louisa Gordon⁶ , Stefano Occhipinti² and Joanne Aitken^1,7

¹Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia

²School of Psychology, Griffith University, Brisbane, Australia

³National Executive, Australian Prostate Cancer Collaboration, Melbourne, Australia

⁴Department of Surgery, University of Queensland, Brisbane, Australia

⁵Department of Urology, Princess Alexandra Hospital, Brisbane, Australia

⁶Cancer and Population Health Studies, Queensland Institute of Medical Research, Brisbane, Australia

⁷School of Population Health, University of Queensland, Brisbane, Australia

author email corresponding author email

BMC Cancer 2008, 8:207doi:10.1186/1471-2407-8-207

Published:	24 July 2008

Abstract

Background

Prostate cancer is the most common male cancer in the Western world but is highly heterogeneous in disease progression and outcomes. Consequently, the most substantial morbidity may actually arise from the adverse psychosocial impact of distress in decision-making and long term quality of life effects such as impotence. This paper presents the design of a randomised controlled trial of a decision support/psychosocial intervention for men newly diagnosed with localised prostate cancer.

Methods/Design

350 men per condition (700 men in total) have been recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to 1) a tele-based nurse delivered five session decision support/psychosocial intervention or 2) a usual care control group. Two intervention sessions are delivered before treatment that address decision support, stress management and preparation for treatment. Three further sessions are provided three weeks, seven weeks and five months after treatment that focus on adjustment to cancer, problem solving and coping with treatment side effects. Participants are assessed at baseline (before treatment) and 2, 6, 12, 24 and 36 months post-treatment. Outcome measures include: cancer threat appraisal; decision-related distress and bother from treatment side effects; involvement in decision making; satisfaction with health care; heath care utilisation; use of health care resources; and a return to previous activities.

Discussion

The study will provide recommendations about the efficacy of early decision support to facilitate adjustment after prostate cancer. As well the study will identify men diagnosed with localised prostate cancer at risk of poorer long term psychosocial adjustment.

Trial Registration

ACTRN012607000233426.