Yoga-based symptom management for metastatic breast cancer

基于瑜伽的转移性乳腺癌症状管理

• 批准号: 8849378
• 负责人: LAURA S PORTER
• 金额: $ 50.29万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8849378
• 关键词: Activities of Daily Living; Address; Adherence; Advanced Malignant Neoplasm; Aftercare; Age; Attention; Breathing; Cancer Pain Management; Characteristics; Comorbidity; Conscious; Control Groups; Data; Diagnostic Neoplasm Staging; Disease; Distress; Dose; Eligibility Determination; Fatigue; Goals; Hour; Intervention; Interview; Lead; Length; Malignant Neoplasms; Measures; Mediating; Mediator of activation protein; Medical; Meditation; Metastatic breast cancer; Moods; Outcome; Pain; Pain management; Participant; Patients; Performance Status; Persons; Pilot Projects; Posture; Protocols documentation; Race; Randomized; Reporting; Research; Sample Size; Self Management; Site; Sleep disturbances; Social support; Symptoms; Techniques; Testing; Time; Treatment Effectiveness; Woman; Yoga; base; behavior measurement; cancer pain; cancer therapy; clinical practice; design; diaries; efficacy testing; experience; follow-up; functional disability; immune function; improved; interest; meetings; novel; palliative; pranayama; preference; psychological distress; satisfaction; standardize measure; symptom management; theories

Pain is one the most frequent, distressing, and debilitating symptoms experienced by women with metastatic breast cancer. Pain is associated with a host of other symptoms including fatigue, sleep disturbance, psychological distress, and functional impairments. Despite medical advances in treating cancer pain, many patients do not experience adequate pain relief. Yoga-based interventions have shown promise for improving the management of pain and pain-related symptoms but have not been tested in the context of metastatic breast cancer or any advanced cancer. Given the high pain and symptom burden associated with metastatic breast cancer, it is imperative to develop palliative interventions to enhance the quality of these women¿s lives. We recently conducted a pilot study to test a novel and comprehensive yoga-based symptom management protocol that combines gentle physical postures (asanas), conscious breathing (pranayama), and meditation techniques (dhyana) specifically designed to address pain and pain-related symptoms commonly experienced in metastatic breast cancer. Data from a small uncontrolled pilot study supported the feasibility of the intervention. The proposed project seeks to more definitely test the feasibility, acceptability, and preliminary efficacy of a comprehensive yoga-based symptom management protocol for women with metastatic breast cancer who are experiencing pain. In this trial, 60 women will be randomly assigned to either the yoga intervention (n=40) or a social support control intervention (n=20). Women in both conditions will attend eight weekly two-hour group sessions. The aims of the study are to determine the feasibility and acceptability of the yoga intervention, to examine the relationship between dose of yoga practice and participant baseline characteristics, and to provide preliminary data on the efficacy of the yoga intervention to improve pain-related symptoms and overall pain. Assessments conducted before and after treatment and at 3-months and 6-months follow up will include patient reports of pain, fatigue, sleep disturbance, and psychological distress, and a behavioral measure of functional capacity. Additional measures will be collected via daily diary throughout the intervention period.

疼痛是转移性乳腺癌患者经历的最常见、最令人痛苦和最令人衰弱的症状之一。疼痛与许多其他症状有关，包括疲劳、睡眠障碍、心理困扰和功能障碍。尽管医学在治疗癌症疼痛方面取得了进步，但许多患者并没有充分的疼痛缓解。基于瑜伽的干预措施已显示出改善疼痛和疼痛相关症状的前景，但尚未在转移性乳腺癌或任何晚期癌症的背景下进行测试。考虑到与转移性乳腺癌相关的高疼痛和症状负担，必须制定姑息性干预措施，以提高这些妇女的生活质量。我们最近进行了一项试点研究，以测试一种新颖而全面的基于瑜伽的症状管理方案，该方案结合了温和的身体姿势（体式），有意识的呼吸（pranayama）和冥想技巧（dhyana），专门用于解决转移性乳腺癌中常见的疼痛和疼痛相关症状。来自一项小型非对照试点研究的数据支持干预的可行性。拟议的项目旨在更明确地测试基于瑜伽的综合症状管理方案对正在经历疼痛的转移性乳腺癌妇女的可行性，可接受性和初步疗效。在这项试验中，60名妇女将被随机分配到瑜伽干预（n=40）或社会支持控制干预（n=20）。这两种情况的女性都将参加每周八次、每次两小时的小组会议。该研究的目的是确定瑜伽干预的可行性和可接受性，检查瑜伽练习剂量与参与者基线特征之间的关系，并提供瑜伽干预改善疼痛相关症状和整体疼痛疗效的初步数据。在治疗前后以及3个月和6个月随访时进行的评估将包括疼痛、疲劳、睡眠障碍和心理困扰的患者报告，以及功能能力的行为测量。在整个干预期间，将通过每日日记收集其他测量值。