Developing a Yoga Intervention for Sleep Disturbance During Cancer Chemotherapy

描述(申请人提供)：这项申请旨在扩大非药理学的选择，通过瑜伽练习控制化疗期间的症状。它特别关注睡眠障碍，其次关注疲劳。睡眠障碍是癌症患者最常见的症状之一，高达80%的患者在化疗期间发生，并导致严重的生活质量损害。虽然药物治疗改善了睡眠障碍，但它们有许多副作用，耐受性和依赖性问题，而且在肿瘤科患者中没有得到很好的研究。虽然非药物疗法可能会减少睡眠障碍，但目前关于其有效性的证据水平还不够。多达95%的接受化疗的人会出现疲劳，并导致功能和生活质量的严重损害。尽管它意义重大，但目前几乎没有有效的治疗疲劳的方法。先前的研究表明，瑜伽可能有助于睡眠障碍和疲劳，但这些研究有局限性。瑜伽研究中的一个重要挑战是，瑜伽通常是一种多模式练习，可以包括身体姿势、呼吸练习和/或冥想部分。以前的研究没有充分解决个别组成部分的影响。因此，瑜伽中最有效的元素是什么；如何针对化疗症状等特殊问题最好地将它们结合起来；以及最佳剂量，这些关键问题仍然没有得到解答。目前的研究将解决文献中的这些空白，并执行关键的开发步骤，为大型随机对照试验(RCT)做准备。它建立在前期工作的基础上，在这些工作中，我们研究了瑜伽呼吸练习对化疗症状的影响，发现了初步证据，表明瑜伽呼吸可以改善睡眠障碍，显示出改善疲劳的趋势，并且在接受化疗的患者中实施是可行的。使用混合方法评估每个干预组件；我们将在接受化疗的癌症患者中执行三个紧密相连的步骤。在目标1(n=12)中，我们将采用个性化的方法进行瑜伽呼吸干预，并反复改进以确保其可行性和可接受性。在AM 2(n=24)中，我们将手动进行瑜伽姿势干预，评估恢复性/静态姿势和流动姿势，并进行迭代改进以测试可行性和可接受性。在AIM 3中 (n=52)，我们将评估最终的多模式瑜伽干预，以选择最终干预元素和剂量，以便在计划中的未来随机对照试验中进行测试。这项应用将有助于改进对衰弱的癌症相关症状的治疗，并推动我们开发治疗性瑜伽干预试验的方法。

DESCRIPTION (provided by applicant): This application aims to expand non-pharmacologic options for the control of symptoms during chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a secondary focus on fatigue. Sleep disturbance is among the most common symptoms experienced by cancer patients, occurs in up to 80% of patients during chemotherapy, and results in serious impairments in quality of life. Although pharmacologic therapies improve sleep disturbance, they have numerous side effects, problems with tolerance and dependence, and are not well studied in oncology patients. While non-pharmacologic therapies may decrease sleep disturbance, the current level of evidence on their efficacy is insufficient. Fatigue occurs in up to 95% of those receiving chemotherapy, and results in major impairments in functioning and quality of life. Despite its significance, few effective treatments currently exist for fatigue. Prior studies suggest that yoga may be helpful for sleep disturbance and fatigue, but these studies have limitations. An important challenge in yoga research is that it is typically a multi-modality practice that can include physical postures, breathing practices, and/or meditation components. Prior studies have not adequately addressed the effects of individual components. Therefore, key questions remain unanswered about the most effective elements of yoga; how to best combine them for particular problems such as chemotherapy symptoms; and optimal dosing. The current study will address these gaps in the literature and perform key developmental steps to prepare for a large randomized, controlled trial (RCT). It builds on preliminary work in which we have studied yoga breathing practices for chemotherapy symptoms and found initial evidence that it improved sleep disturbance, showed trends toward improvements in fatigue, and was feasible to implement in patients undergoing chemotherapy. Using a mixed- methods approach to evaluate each intervention component; we will pursue three closely interlinked steps in cancer patients receiving chemotherapy. In Aim 1 (n=12), we will manualize an individualized approach to the yoga breathing intervention and iteratively refine it to insure feasibility and acceptability. In Am 2 (n=24), we will manualize a yoga posture intervention, evaluating both restorative/static poses and flowing poses, and perform iterative refinement to test feasibility and acceptability. In Aim 3 (n=52), we will assess the final multi- modality yoga intervention to select final intervention elements and doses for testing in a planned future RCT. This application will help to improve the treatment of debilitating cancer associated symptoms and advance our approaches to developing therapeutic yoga intervention trials.