Watson Eila, Rose Peter, Frith Emma, Hamdy Freddie, Neal David, Kastner Christof, Russell Simon, Walter Fiona M, Faithfull Sara, Wolstenholme Jane, Perera Rafael, Weller David, Campbell Christine, Wilkinson Clare, Neal Richard, Sooriakumaran Prasanna, Butcher Hugh, Matthews Mike
Department of Clinical Health Care, Oxford Brookes University, Oxford, UK.
Department of Primary Health Care, University of Oxford, Oxford, UK.
BMJ Open. 2014 May 22;4(5):e005186. doi: 10.1136/bmjopen-2014-005186.
Prostate cancer survivors can experience physical, sexual, psychological and emotional problems, and there is evidence that current follow-up practices fail to meet these men's needs. Studies show that secondary and primary care physicians see a greater role for primary care in delivering follow-up, and that primary care-led follow-up is acceptable to men with prostate cancer.
A two-phase study with target population being men who are 9-24 months from diagnosis. Phase 1 questionnaire aims to recruit 300 men and measure prostate-related quality of life and unmet needs. Men experiencing problems with urinary, bowel, sexual or hormonal function will be eligible for phase 2, a pilot trial of a primary care nurse-led psychoeducational intervention. Consenting eligible participants will be randomised either to intervention plus usual care, or usual care alone (40 men in each arm). The intervention, based on a self-management approach, underpinned by Bandura's Social Cognitive Theory, will provide advice and support tailored to these men's needs and address any problems they are experiencing. Telephone follow-up will take place at 6 months. Study outcomes will be measured by a questionnaire at 7 months. Phase 1 will allow us to estimate the prevalence of urinary, sexual, bowel and hormone-related problems in prostate cancer survivors and the level of unmet needs. 'Usual care' will also be documented. Phase 2 will provide information on recruitment and retention, acceptability of the intervention/outcome measures, effect sizes of the intervention and cost-effectiveness data, which is required to inform development of a larger, phase 3 randomised controlled trial. The main outcome of interest is change in prostate-cancer-related quality of life. Methodological issues will also be addressed.
Ethics approval has been gained (Oxford REC A 12/SC/0500). Findings will be disseminated in peer-reviewed journals, at conferences, through user networks and relevant clinical groups.
ISRCTN 97242511.
前列腺癌幸存者可能会经历身体、性、心理和情绪方面的问题，并且有证据表明当前的随访措施未能满足这些男性的需求。研究表明，二级和初级保健医生认为初级保健在提供随访方面应发挥更大作用，并且由初级保健主导的随访对于前列腺癌男性患者是可接受的。
一项分两阶段的研究，目标人群为确诊后9至24个月的男性。第一阶段问卷旨在招募300名男性，并测量与前列腺相关的生活质量和未满足的需求。在泌尿、肠道、性或激素功能方面存在问题的男性将有资格进入第二阶段，即由初级保健护士主导的心理教育干预的试点试验。同意参与的符合条件的参与者将被随机分为干预加常规护理组或仅常规护理组（每组40名男性）。该干预基于自我管理方法，以班杜拉的社会认知理论为基础，将根据这些男性的需求提供建议和支持，并解决他们正在经历的任何问题。将在6个月时进行电话随访。研究结果将在7个月时通过问卷进行测量。第一阶段将使我们能够估计前列腺癌幸存者中泌尿、性、肠道和激素相关问题的患病率以及未满足需求的程度。“常规护理”情况也将被记录。第二阶段将提供有关招募和留存、干预/结果测量的可接受性、干预的效应大小和成本效益数据的信息，这些信息是开展更大规模的第三阶段随机对照试验所必需的。主要关注的结果是与前列腺癌相关的生活质量的变化。还将解决方法学问题。
已获得伦理批准（牛津研究伦理委员会A 12/SC/0500）。研究结果将在同行评审期刊、会议上、通过用户网络和相关临床组进行传播。
ISRCTN 97242511。
