Developing a Yoga Intervention for Sleep Disturbance During Cancer Chemotherapy

开发瑜伽干预措施来治疗癌症化疗期间的睡眠障碍

• 批准号: 8915056
• 负责人: Anand Dhruva
• 金额: $ 26.88万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8915056
• 关键词: Absenteeism; Address; Adherence; Adjuvant; Adverse effects; Affect; Awareness; Breathing; Cancer Patient; Chemotherapy-Oncologic Procedure; Colon Carcinoma; Complementary and alternative medicine; Cyclophosphamide; Data; Dependence; Development; Dose; Down-Regulation; Elements; Fatigue; Feedback; Future; Health; Immune system; Impairment; Individual; Intervention; Intervention Trial; Level of Evidence; Literature; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of lung; Meditation; Methods; Modality; National Center for Complementary and Alternative Medicine; Outcome; Participant; Patients; Phase; Pilot Projects; Posture; Preparation; Productivity; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Regulation; Reporting; Research; Safety; Sample Size; Side; Sleep; Sleep disturbances; Symptoms; Testing; Therapeutic; Therapeutic Effect; United States; Work; Yoga; cancer therapy; chemotherapy; effective intervention; effective therapy; efficacy trial; experience; flexibility; health care service utilization; improved; instructor; malignant breast neoplasm; oncology; patient population; prevent; research study; response; therapy development; trend

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.

描述（由申请人提供）：本申请旨在扩大使用瑜伽练习控制化疗期间症状的非药物选择。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% 的患者在化疗期间会出现睡眠障碍，并导致生活质量严重受损。尽管药物疗法可以改善睡眠障碍，但它们具有许多副作用、耐受性和依赖性问题，并且在肿瘤患者中尚未得到充分研究。虽然非药物疗法可能会减少睡眠障碍，但目前其功效的证据水平还不够。高达 95% 的化疗患者会出现疲劳，导致功能和生活质量严重受损。尽管其意义重大，但目前针对疲劳的有效治疗方法还很少。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/或冥想成分。先前的研究尚未充分解决各个成分的影响。因此，关于瑜伽最有效的要素的关键问题仍未得到解答。如何最好地将它们结合起来解决特定问题，例如化疗症状；和最佳剂量。当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。使用混合方法来评估每个干预组成部分；我们将对接受化疗的癌症患者采取三个紧密相连的步骤。在目标 1（n=12）中，我们将手动制定个性化的瑜伽呼吸干预方法，并迭代完善它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，并进行迭代细化以测试可行性和可接受性。目标 3 (n=52)，我们将评估最终的多模式瑜伽干预，以选择最终的干预元素和剂量，以便在计划的未来随机对照试验中进行测试。该应用程序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。