Developing a Yoga Intervention for Sleep Disturbance During Cancer Chemotherapy

描述（由申请人提供）：本申请旨在通过瑜伽练习扩展化疗期间控制症状的非药物选择。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%的患者在化疗期间出现睡眠障碍，并导致生活质量严重受损。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，并且在肿瘤患者中没有得到很好的研究。虽然非药物疗法可以减少睡眠障碍，但目前关于其有效性的证据还不够。95%接受化疗的患者会出现疲劳，并导致功能和生活质量的严重受损。尽管它具有重要意义，但目前很少有有效的治疗疲劳的方法。先前的研究表明，瑜伽可能有助于缓解睡眠障碍和疲劳，但这些研究都有局限性。瑜伽研究的一个重要挑战是，它是一种典型的多模态练习，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解决个别成分的影响。因此，关于瑜伽最有效的元素的关键问题仍然没有答案；如何最好地结合它们来解决特定问题，如化疗症状；以及最佳剂量。目前的研究将解决这些文献中的空白，并执行关键的发展步骤，为大型随机对照试验（RCT）做准备。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，表明瑜伽呼吸练习改善了睡眠障碍，有改善疲劳的趋势，并且在接受化疗的患者中实施是可行的。采用混合方法评估每个干预成分；我们将在接受化疗的癌症患者中采取三个密切相关的步骤。在目标1 （n=12）中，我们将手动制定一种个性化的瑜伽呼吸干预方法，并对其进行迭代完善，以确保可行性和可接受性。在Am 2 （n=24）中，我们将手动进行瑜伽姿势干预，评估恢复/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。目标3

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.