title: Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.
abstract: Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5-10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented.
authors.affiliation: Academic Unit of Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PA, UK.
authors.forename: Theresa Helen Mazzarello
authors.initials: TH
authors.lastname: Moore
authors.affiliation: Academic Unit of Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PA, UK.
authors.forename: Anna Jyoti Louise
authors.initials: AJ
authors.lastname: King
authors.affiliation: Academic Unit of Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PA, UK.
authors.forename: Maggie
authors.initials: M
authors.lastname: Evans
authors.affiliation: Academic Unit of Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PA, UK.
authors.forename: Debbie
authors.initials: D
authors.lastname: Sharp
authors.affiliation: Academic Unit of Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PA, UK.
authors.forename: Raj
authors.initials: R
authors.lastname: Persad
authors.affiliation: Academic Unit of Primary Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PA, UK.
authors.forename: Alyson Louise
authors.initials: AL
authors.lastname: Huntley
mesh_terms: D000223:Adaptation, Psychological; D000339:Affect; D001007:Anxiety; D003362:Cost-Benefit Analysis; D003863:Depression; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011471:Prostatic Neoplasms / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D020377:Self Efficacy
keywords: Critical appraisal; prostate cancer; randomized controlled trials; supportive care; systematic review
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