A randomised, wait-list controlled trial: evaluation of a cognitive-behavioural group intervention on psycho-sexual adjustment for men with localised prostate cancer.

OBJECTIVE: To examine the effectiveness of a cognitive-behavioural therapy (CBT) group intervention to facilitate improved psycho-sexual adjustment to treatment side effects in prostate cancer survivors post-radical prostatectomy. METHODS: A randomised, wait-list controlled trial was conducted with a total of 60 men who participated in a manualised 8-week cognitive-behavioural group intervention 6 months to 5 years post-radical prostatectomy for localised prostate cancer. Participants completed standardised questionnaires pre-intervention and post-intervention, which assessed mood state, stress, general and prostate cancer anxiety, quality of life and areas of sexual functioning. RESULTS: Paired samples t-tests identified a significant improvement in sexual confidence, masculine self-esteem, sexual drive/relationship and a significant decline in sexual behaviour from pre-intervention to post-intervention. Hierarchical regression analyses revealed that after controlling for covariates, participation in the group intervention significantly improved sexual confidence, sexual intimacy, masculine self-esteem and satisfaction with orgasm. CONCLUSIONS: This group-based CBT intervention for men post-radical prostatectomy for localised prostate cancer shows promising results in terms of improving quality of life.

A qualitative assessment of the experience of participating in a cancer-related clinical trial.

PURPOSE: This study aims to explore the experiences of patients enrolled in a cancer-related clinical drug treatment trial utilising a qualitative focus-group methodology. Specifically, this study aimed to explore the impact of social and family support, the challenges and advantages of taking part in a clinical trial and the experiences of patients at the conclusion of the trial. METHODS: A qualitative study was conducted at a public hospital in Melbourne in 2008. A total of 14 participants were recruited. Three focus groups and two interviews were conducted with 13 patients who had completed a cancer-related clinical trial. Comments from a letter written by a trial participant were also analysed. Interviews were audio-recorded, transcribed and coded according to emerging themes. RESULTS: Information obtained was grouped around four main themes; making sense of trial participation, challenges of treatment in the context of clinical trial participation, support during trial participation and coping with trial conclusion. Participants experienced a mixture of hope, uncertainty and apprehension as they considered whether to take part in a clinical trial. At different stages of the trial they made sense of their participation by thinking about the possible benefits of participation. Trial participation was also associated with a number of emotional and practical challenges. Generally, participants were very positive about the support they received from health professionals, family and friends. The end of the trial was associated with a mix of emotions, including relief, disappointment, hope of future help, uncertainty and abandonment. CONCLUSIONS: Clinical trial participation is a positive experience for many patients with cancer, although there are a number of associated practical and emotional challenges. Trial participants may benefit from closer follow-up from clinical trial staff, especially the treating doctor, assessment of support needs and help in re-evaluating the meaning of their trial participation if their initial hopes and expectations are not met.