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

描述（由申请人提供）：本探索性研究针对接受前列腺癌放射治疗（雄激素剥夺治疗）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，它们可能不会被发现。患者可能由于尴尬、认为提供者忙碌或缺乏对干预措施可用性的认识而不报告问题。缺乏系统的教育项目来教病人自我护理策略，他们可以使用这些策略来控制他们的症状。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。对于交通条件有限的老年男性以及居住在缺乏资源的小城镇或农村社区的老年人来说，这种情况更加严重。这项研究的长期目标是为越来越多的癌症幸存者找到改善生活质量的最有效方法。本初步研究的总体目的是：(1)测试可行性；(2)建立初步疗效，并估计为老年男性前列腺癌患者提供系统的、结构化的、基于证据的症状管理干预的效应大小。T3症状管理是一种创新的方法，针对男性前列腺癌患者所经历的症状，根据男性首选的学习方法量身定制，并在症状最有可能发生的时候进行调整。“T3”干预提供了一种模式，以接触老年成年前列腺幸存者，包括来自农村社区的男性，因为他们正在完成放射治疗。本初步研究是一项探索性临床试验，采用重复测量的实验性“患者偏好”设计，以2:1的比例比较两个研究组：(1)T3症状管理干预，患者在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（60岁及以上）正在完成前列腺癌放射治疗（雄激素剥夺治疗）并经历中度症状困扰的男性将被招募到犹他州和亚利桑那州的两个地点参加这项研究。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将通过电脑（仅限自我指导小组）、邮件或电话提供，从而使农村和城市的前列腺癌男性都能获得。六分之一的男性会患上前列腺癌。本探索性研究解决了针对前列腺癌接受放射治疗（雄激素剥夺治疗）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，它们可能不会被发现。患者可能由于尴尬、认为提供者忙碌或缺乏对干预措施可用性的认识而不报告问题。这个项目可以通过测试一种创新的方法来提高前列腺癌患者的生活质量，这种方法可以针对令人烦恼的症状，并允许男性选择他们想要学习的方式。

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.