Emery Jon, Doorey Juanita, Jefford Michael, King Madeleine, Pirotta Marie, Hayne Dickon, Martin Andrew, Trevena Lyndal, Lim Tee, Constable Roger, Hawks Cynthia, Hyatt Amelia, Hamid Akhlil, Violet John, Gill Suki, Frydenberg Mark, Schofield Penelope
General Practice and Primary Health Care Academic Centre, The University of Melbourne, Carlton, Victoria, Australia.
BMJ Open. 2014 Mar 6;4(3):e004972. doi: 10.1136/bmjopen-2014-004972.
Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer.
The intervention is a shared care model of follow-up visits in the first 12 months after completing treatment for prostate cancer with the following specific components: a survivorship care plan, general practitioner (GP) management guidelines, register and recall systems, screening for distress and unmet needs and patient information resources. Eligible men will have completed surgery and/or radiotherapy for low-moderate risk prostate cancer within the previous 8 weeks and have a GP who consents to participate. Ninety men will be randomised to the intervention or current hospital follow-up care. Study outcome measures will be collected at baseline, 3, 6 and 12 months and include anxiety, depression, unmet needs, prostate cancer-specific quality of life and satisfaction with care. Clinical processes and healthcare resource usage will also be measured. The principal emphasis of the analysis will be on obtaining estimates of the treatment effect size and assessing feasibility in order to inform the design of a subsequent phase III trial.
Ethics approval has been granted by the University of Western Australia and from all hospital recruitment sites in Western Australia and Victoria.
of this phase II trial will be reported in peer-reviewed publications and in conference presentations.
Australian New Zealand Clinical Trial Registry ACTRN12610000938000.
前列腺癌男性患者需要长期随访，以监测疾病进展并处理治疗常见的不良身体和心理社会后果。人们越来越认识到初级保健在癌症随访中的潜在作用。本文描述了一项II期多中心随机对照试验的方案，该试验针对低中危前列腺癌患者完成治疗后的随访采用一种新型共享护理模式。
干预措施是在前列腺癌治疗完成后的前12个月采用共享护理随访模式，包括以下具体内容：生存护理计划、全科医生（GP）管理指南、登记和召回系统、筛查痛苦和未满足的需求以及患者信息资源。符合条件的男性需在过去8周内完成低中危前列腺癌的手术和/或放疗，且有同意参与的全科医生。90名男性将被随机分配至干预组或现行的医院随访护理组。研究结局指标将在基线、3个月、6个月和12个月时收集，包括焦虑、抑郁、未满足的需求、前列腺癌特异性生活质量以及对护理的满意度。还将测量临床过程和医疗资源使用情况。分析的主要重点将是获得治疗效果大小的估计值并评估可行性，以便为后续III期试验的设计提供信息。
已获得西澳大利亚大学以及西澳大利亚和维多利亚州所有医院招募地点的伦理批准。
本II期试验的结果将在同行评审出版物和会议报告中公布。
澳大利亚新西兰临床试验注册中心ACTRN12610000938000。
