ProsCan for men: randomised controlled trial of a decision support intervention for men with localised prostate cancer.
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
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.


CONCLUSIONS
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.


BACKGROUND
ACTRN012607000233426.
Chambers
Suzanne K
SK
Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia. suzannechambers@cancerqld.org.au
Ferguson
Megan
M
Gardiner
R A
RA
Nicol
David
D
Gordon
Louisa
L
Occhipinti
Stefano
S
Aitken
Joanne
J
D000223:Adaptation, Psychological; D000465:Algorithms; D003657:Decision Making; D003661:Decision Support Techniques; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D013315:Stress, Psychological / Q000175:diagnosis / Q000628:therapy*; D017216:Telemedicine / Q000379:methods; D013997:Time Factors; D014572:Urology / Q000379:methods*