Developing and Pilot-testing a Yoga Program to Address Post-prostatectomy Side-effects Among Veterans with Prostate Cancer

背景：前列腺癌（PCa）占2010年所有新发癌症诊断的30%， 退伍军人健康管理局（VHA），因此是最常治疗的癌症， 老兵那些接受根治性乳房切除术（RP）治疗的患者通常会出现副作用 包括勃起功能障碍（艾德）和尿失禁（UI）。治疗的副作用往往 持续多年，并可能导致焦虑和抑郁。瑜伽包括呼吸练习， 冥想和身体姿势可能是治疗RP副作用的有效干预措施。到 促进吸收并最大限度地发挥其有效性，我们建议在手术前开始干预 （预处理）并使用混合方法（即，现场和在线会议）。 意义/影响：VHA为50万癌症幸存者提供护理，其中 近一半是PCa幸存者。随着人口老龄化和治疗， 变得更加有效。因此，VHA必须了解如何最好地增强 被诊断患有癌症的人的生存质量和长度。此外，VHA和健康 服务研究和开发计划认识到使用“整体健康”的重要性 支持退伍军人的健康和福祉。本干预措施符合 整体健康的目的，通过与退伍军人合作，创建一个个性化的瑜伽计划的基础上， 自己的目标和需求。 创新：拟议的干预措施在几个方面具有创新性。首先，它将瑜伽应用于 相对较新的患者人群（PCa男性）和结局集（艾德和UI）。二是 干预是为患者量身定制的，并使用混合模型进行递送。第一会话 在人和用于定制瑜伽姿势根据退伍军人的舒适和能力。后续 会议将与正在进行的患者队列一起在线进行。第三，干预措施包括 预防成分，旨在进一步抑制RP的副作用。 具体目的：本研究的长期目标是优化患者的生活质量和 对于患有前列腺癌的男性来说。为此，我们寻求评估创新混合的可行性， （面对面和在线）瑜伽课程，并获得其潜在有效性的初步数据， 减轻PCa治疗症状负担。具体目标是：1）确定可行性 （包括需求、安全性和可接受性） 切除术; 2）获得初步数据，以估计干预的潜在影响， 艾德和UI（主要结局）、幸福感（例如，癌症疲劳、压力、焦虑）和生活质量。 方法：对于这项试点研究，30名正在接受根治性乳房切除术的退伍军人 PCa治疗将随机分配至干预或标准治疗组。述干预 每周两次的混合瑜伽计划，其中包括康复前阶段。艾德和UI（主要 结果）以及心理健康状况（例如压力、焦虑），包括QoL（次要 成果）。将跟踪并比较各组之间的计划吸收和流失情况。基线和 将通过调查收集关于结果的后续数据。将密切监测安全性。退伍军人 将通过干预后评估对方案的经验和看法 调查. 后续步骤/实施：我们预计干预将是可行的，安全的， 并提供一些潜在疗效的证据。随后，我们打算 充分评估干预的有效性，同时探索其在VHA中的更广泛适应性。

Background: Prostate cancer (PCa) constitutes 30% of all new cancer diagnoses in the Veterans Health Administration (VHA) and as such is the most frequently treated cancer among Veterans. Those who are treated with radical prostatectomy (RP) often experience side effects including erectile dysfunction (ED) and urinary incontinence (UI). The side effects of treatment often persist for years and can contribute to anxiety and depression. Yoga, which includes breath work, meditation, and physical poses, may be an effective intervention for treating side effects of RP. To facilitate uptake and maximize its effectiveness, we propose to initiate the intervention prior to surgery (prehabilitation) and deliver it using a blended approach (i.e., in-person and online sessions). Significance/Impact: The VHA provides care to half a million cancer survivors, of which nearly half are PCa survivors. This number is expected to grow as the population ages and treatments become more effective. It is therefore critical for the VHA to understand how best to enhance the quality and length of survival of those diagnosed with cancer. Furthermore, the VHA and Health Services Research and Development program recognize the importance of using a “Whole Health” approach to supporting the health and well-being of Veterans. This intervention aligns with the purpose of Whole Health by partnering with Veterans to create a personalized yoga plan based on their own goals and needs. Innovation: The proposed intervention is innovative in several ways. First, it applies yoga to a relatively new patient population (men with PCa) and sets of outcomes (ED and UI). Second, the intervention is being tailored to the patient and delivered using a blended model. The first session is in-person and used to tailor the yoga poses according to a Veteran's comfort and ability. Subsequent sessions will take place online alongside ongoing patient cohorts. Third, the intervention includes a prehabilitation component that aims to further dampen the side effects of RP. Specific Aims: The long-term goal of this research is to optimize the QoL and patient experience for men with PCa. To that end, we seek to assess the feasibility of an innovative blended (in-person and online) yoga program and to obtain preliminary data on its potential effectiveness in alleviating PCa treatment symptom burden. The specific aims are to: 1) determine the feasibility (including demand, safety and acceptability) of the intervention for men receiving a radical prostatectomy; and 2) obtain preliminary data to estimate the potential impact of the intervention on ED and UI (primary outcomes), well-being (e.g., cancer fatigue, stress, anxiety), and QoL. Methodology: For this pilot study, 30 Veterans who are undergoing a radical prostatectomy for PCa treatment will be randomized to either the intervention or standard of care. The intervention is a blended twice-weekly yoga program that includes a prehabilitation phase. ED and UI (primary outcomes) as well as mental health well-being (e.g. stress, anxiety), including QoL (secondary outcomes). Program uptake and attrition will be tracked and compared between groups. Baseline and follow-up data on outcomes will be collected via survey. Safety will be closely monitored. Veterans' experiences with and perceptions of the programs will be assessed through a post-intervention survey. Next Steps/Implementation: We anticipate that the intervention will be feasible, safe, and acceptable to Veterans and provide some evidence of potential efficacy. Subsequently, we intend to fully evaluate the efficacy of the intervention while exploring its broader adaptation in VHA.