Targeted, Tailored and Timely (T3) Symptom Management for Prostate Cancer

描述(由申请人提供)：这项探索性研究针对接受前列腺癌放射治疗(雄激素剥夺疗法)的男性缺乏系统和结构化的症状管理。由于没有对症状进行系统和定期的评估，它们可能无法被发现。患者可能不会因为尴尬、提供者的忙碌或缺乏对干预措施的认识而报告问题。缺乏系统的教育计划来教导患者可以使用的自我护理策略来管理他们的症状。随着治疗的结束，在最需要的时候获得症状管理的机会减少了。对于交通工具有限的老年男子以及居住在资源匮乏的小城镇或农村社区的人来说，这种缺乏机会的情况更加严重。这项研究的长期目标是为不断增加的癌症幸存者开发最有效的提高生活质量的方法。这项初步研究的总体目标是(1)测试可行性和(2)确定为前列腺癌老年男性患者提供系统的、结构化的、基于证据的症状管理干预的初步疗效和效果大小。T3症状管理是一种创新的方法，针对前列腺癌男性患者经历的症状，根据男性首选的学习方法量身定做，并根据症状最有可能发生的时间进行计时。“T3”干预提供了一种模式，可以在老年前列腺癌幸存者完成放射治疗时接触到他们，包括来自农村社区的男性。作为一项针对疲倦、失眠、疼痛、排尿和肠道问题、潮热、抑郁和焦虑的临床试验，这项试验性研究是一项探索性临床试验，采用试验性的“患者偏好”设计，重复测量，两组研究将以2：1的比例进行比较：(1)T3症状管理干预，患者从三种首选学习方法中选择一种(n=72)或(2)常规护理(n=36)。108名正在接受前列腺癌放射治疗(雄激素剥夺疗法)并经历中度症状困扰的男性(60岁及以上)将从犹他州和亚利桑那州的两个环境中招募参加这项研究。预计40%的参与者(n=43)将居住在农村社区。所有的干预和数据收集方法都将通过计算机(仅限自我指导小组)、邮件或电话提供，从而使农村和城市前列腺癌男性都能获得这些方法。每6名男性中就有一人会患前列腺癌。这项探索性研究针对接受前列腺癌放射治疗(雄激素剥夺疗法)的男性缺乏系统和结构化的症状管理。由于没有对症状进行系统和定期的评估，它们可能无法被发现。患者可能不会因为尴尬、提供者的忙碌或缺乏对干预措施的认识而报告问题。这项计划可以通过测试一种针对麻烦症状的创新方法，并允许男性选择他们想要的学习方式，来帮助增加关于如何提高前列腺癌男性患者的生活质量的知识。

DESCRIPTION (provided by applicant): This exploratory study addresses the lack of systematic and structured symptom management targeted to men receiving radiation therapy ( androgen deprivation therapy) for prostate cancer. Because there is not a systematic and regular assessment of symptoms, they may go undetected. Patients may not report problems due to embarrassment, perceived busyness of providers, or lack of recognition that interventions are available to help. There is a lack of systematic educational programs to teach patients the self-care strategies that they can employ to manage their symptoms. As treatment ends, access to symptom management dwindles at the time when it is needed the most. This lack of access is compounded for older men who may have limited transportation and for those who reside in small towns or rural communities where resources are lacking. The long term goal of this research is to develop the most effective ways of improving quality of life for the increasing number of cancer survivors. The overall aims of this pilot study are (1) to test the feasibility and (2) to establish the initial efficacy and estimate the effect size of providing a systematic, structured, evidence- based symptom management intervention for older adult men with prostate cancer. T3 symptom management is an innovative approach which is targeted to the symptoms experienced by men with prostate cancer, tailored to the man's preferred learning method, and timed to when the symptoms are most likely to occur. The "T3" intervention provides a model to reach older adult prostate survivors, including men from rural communities, as they are completing radiation therapy. The targeted symptoms fatigue, insomnia, pain, urinary and bowel problems, hot flashes, depression and anxiety, This pilot study is an exploratory clinical trial which uses an experimental "patient preference" design with repeated measures in which two study groups will be compared in a 2:1 ratio: (1) the T3 symptom management intervention in which patients choose one of three preferred learning methods (n=72) or (2) usual care (n=36). One hundred and eight men (age 60 and older) who are completing radiation therapy ( androgen deprivation therapy) for prostate cancer and experiencing either a moderate level of symptom distress will be recruited to participate in the study from 2 settings in Utah and Arizona. It is anticipated that 40% of the participants (n=43) will reside in rural communities. All intervention and data collection methods will be delivered via computer (self-directed group only), mail, or telephone thus making them accessible to both rural and urban men with prostate cancer. One in 6 men will develop prostate cancer. This exploratory study addresses the lack of systematic and structured symptom management targeted to men receiving radiation therapy ( androgen deprivation therapy) for prostate cancer. Because there is not a systematic and regular assessment of symptoms, they may go undetected. Patients may not report problems due to embarrassment, perceived busyness of providers, or lack of recognition that interventions are available to help. This program can contribute to increasing knowledge about how to improve quality of life for men with prostate cancer by testing an innovative approach that targets troublesome symptoms and allows men to choose how they want to learn.