Chambers Suzanne K, Ferguson Megan, Gardiner R A, Nicol David, Gordon Louisa, Occhipinti Stefano, Aitken Joanne
Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia.
BMC Cancer. 2008 Jul 24;8:207. doi: 10.1186/1471-2407-8-207.
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.
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.
ACTRN012607000233426.
前列腺癌是西方世界最常见的男性癌症，但在疾病进展和预后方面具有高度异质性。因此，最严重的发病情况实际上可能源于决策过程中的痛苦所带来的不良心理社会影响以及诸如阳痿等对长期生活质量的影响。本文介绍了一项针对新诊断为局限性前列腺癌男性的决策支持/心理社会干预随机对照试验的设计。
方法/设计：通过泌尿外科私人诊所和医院门诊，在诊断后但治疗前招募了每种情况350名男性（共700名男性），并随机分为1）由护士通过电话进行的为期五节的决策支持/心理社会干预组，或2）常规护理对照组。在治疗前进行两节干预课程，内容涉及决策支持、压力管理和治疗准备。在治疗后三周、七周和五个月再提供三节课程，重点是适应癌症、解决问题和应对治疗副作用。在基线（治疗前）以及治疗后2、6、12、24和36个月对参与者进行评估。结果指标包括：癌症威胁评估；与决策相关的痛苦和治疗副作用带来的困扰；参与决策的程度；对医疗保健的满意度；医疗保健利用率；医疗保健资源的使用情况；以及恢复到以前的活动。
该研究将提供有关早期决策支持对促进前列腺癌后适应的疗效的建议。此外，该研究还将识别出被诊断为局限性前列腺癌且有长期心理社会适应较差风险的男性。
ACTRN012607000233426。
