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)占所有新诊断的癌症的30%。 退伍军人健康管理局(VHA)，因此是最常治疗的癌症 退伍军人。那些接受根治性前列腺切除术(RP)的人经常会出现副作用。 包括勃起功能障碍(ED)和尿失禁(UI)。治疗的副作用通常是 持续数年，会导致焦虑和抑郁。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。至 促进摄取并最大化其有效性，我们建议在手术前开始干预 (康复)，并使用混合方法(即面对面和在线会议)交付。 意义/影响：VHA为50万癌症幸存者提供护理，其中 近一半是PCA的幸存者。这一数字预计会随着人口老龄化和治疗而增长。 变得更有效率。因此，对VHA来说，了解如何最好地增强 被诊断为癌症患者的生存质量和生存时间。此外，VHA与健康 服务研究和发展计划认识到使用“整体健康”的重要性 支持退伍军人健康和福祉的方法。这一干预与 通过与退伍军人合作创建个性化瑜伽计划的整体健康目标 他们自己的目标和需求。 创新：拟议的干预在几个方面都是创新的。首先，它将瑜伽应用于 相对较新的患者群体(患有前列腺癌的男性)和结果集(ED和UI)。第二， 干预措施是为患者量身定做的，并使用混合模式提供。第一节课是 面对面，用于根据老兵的舒适度和能力量身定做瑜伽姿势。后续 会议将在网上与正在进行的患者队列一起进行。第三，干预措施包括 旨在进一步抑制RP副作用的康复组件。 具体目标：本研究的长期目标是优化生活质量和患者 前列腺癌患者的经验。为此，我们寻求评估创新混合的可行性。 (面对面和在线)瑜伽计划，并获得有关其潜在有效性的初步数据 减轻自控镇痛治疗的症状负担。具体目标是：1)确定可行性 (包括需求、安全性和可接受性)对接受激进治疗的男性的干预 以及2)获得初步数据，以评估干预对 ED和UI(主要结果)、幸福感(例如，癌症疲劳、压力、焦虑)和生活质量。 方法：在这项初步研究中，30名退伍军人接受了根治性前列腺切除术 对于PCA，治疗将随机分为干预组或标准护理组。干预措施是 每周两次的混合式瑜伽课程，其中包括康复阶段。ED和UI(主要 结果)以及心理健康幸福感(如压力、焦虑)，包括生活质量(次要的 结果)。将跟踪并比较不同组之间的计划吸收和自然减员。基线和 结果的后续数据将通过调查收集。安全将受到严密监控。退伍军人协会 对这些方案的经验和看法将通过干预后评估 调查。 下一步/实施：我们预计干预将是可行、安全和 退伍军人可以接受，并提供了一些潜在疗效的证据。随后，我们打算 在充分评估干预效果的同时，探索其在VHA中的更广泛适应。

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.