Developing a Yoga Intervention for Sleep Disturbance During Cancer Chemotherapy

描述（由申请人提供）：本申请旨在扩展非药物选择，用于使用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，在化疗期间发生在高达80%的患者中，并导致生活质量严重受损。虽然药物治疗可以改善睡眠障碍，但它们有许多副作用，耐受性和依赖性问题，并且在肿瘤患者中没有得到很好的研究。虽然非药物治疗可能会减少睡眠障碍，但目前关于其疗效的证据不足。在接受化疗的患者中，高达95%的人会出现疲劳，并导致功能和生活质量的重大损害。尽管它的重要性，目前很少有有效的治疗疲劳。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，它通常是一种多模态练习，可以包括身体姿势，呼吸练习和/或冥想成分。先前的研究没有充分说明单个组分的影响。因此，关于瑜伽最有效的元素的关键问题仍然没有答案;如何最好地将它们联合收割机用于特定问题，如化疗症状;以及最佳剂量。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。它建立在初步工作的基础上，我们研究了瑜伽呼吸练习对化疗症状的影响，并发现了初步证据，表明它改善了睡眠障碍，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。使用混合方法的方法来评估每个干预组成部分;我们将在接受化疗的癌症患者中进行三个密切相关的步骤。在目标1（n=12）中，我们将为瑜伽呼吸干预制定个性化的方法，并反复完善，以确保可行性和可接受性。在上午2（n=24），我们将手动瑜伽姿势干预，评估恢复/静态姿势和流动的姿势，并进行迭代优化，以测试可行性和可接受性。在目标3 （n=52），我们将评估最终的多模态瑜伽干预，以选择最终的干预元素和剂量，用于在计划的未来RCT中进行测试。这一应用将有助于改善癌症相关症状的治疗，并推进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.