Qigong Effects on Fatigue & Cognitive Function after Treatment for Breast Cancer

描述（由申请人提供）：乳腺癌患者经常报告生活质量（QOL）的缺陷，包括疲劳和认知功能障碍，在治疗结束后持续存在。乳腺癌患者选择的CAM方式之一是基于中医的气功练习。我们建议测试一套医学气功练习对40-70岁的I期或II期乳腺癌疲劳幸存者的疲劳和其他症状的潜在影响。经过6个月至5年的乳腺癌治疗并符合疲劳资格标准的患者将被随机分配到3个月的干预组，其中一组是(a)一系列温和的医学气功（MQ）练习，由东方医学博士/气功大师开发并指导，专为乳腺癌康复中的女性设计，另一组是(b)安静运动（RM）。针对乳腺癌患者的一系列伸展和运动，大致基于Lebed康复方法和淋巴水肿预防运动，每组30名参与者。宁静运动协议不会被设计为强调气的运动（也就是说，不会包括呼吸训练，也不会教授培养气，这是气功练习的核心特征）。主要终点将使用(a)疲劳症状量表和FACT-COG和(b)认知表现的客观测量，包括注意和工作记忆的数字跨度和字母/数字排序测试。次要指标包括睡眠质量、抑郁和总体生活质量。具体目标为了测试是否医学气功（MQ）练习有意识的呼吸技术，可视化和意图平衡气比宁静运动（RM）更有效地改善女性乳腺癌治疗后的症状。假设一：MQ比RM更能改善乳腺癌幸存者的疲劳程度。假设二：MQ比RM更能改善乳腺癌幸存者的认知功能。具体目标2。检查(a)可能与MQ所声称的影响相关的机制和(b)对影响的其他解释。所有参与者的血液分析将检查淋巴细胞计数、T细胞亚群和血清细胞因子。如果结果是积极的，结果将用于计划RO1提案，以测试医学气功与RM和常规护理对照，为显著性提供动力，包括对气功练习对疲劳、认知功能和免疫/炎症标志物相关的潜在影响结果的作用机制进行更广泛的测试，并跟踪疾病进展结果。

DESCRIPTION (provided by applicant): Patients with breast cancer often report deficits in quality of life (QOL), including fatigue and cognitive dysfunction, that persist after treatment ends. One of the CAM modalities that breast cancer patients choose is the Traditional Chinese Medicine (TCM) based practice of Qigong. We propose to test potential effects of a set of Medical Qigong practices on fatigue, and other symptoms, in fatigued survivors of Stage I or II breast cancer, age 40-70. Patients who are 6 months to 5 years past treatment for breast cancer and meeting eligibility criteria for fatigue will be randomized to a 3-month intervention, either (a) a series of gentle Medical Qigong (MQ) exercises developed and supervised by a Doctor of Oriental Medicine/Master of Qigong and specifically designed for women recovering from breast cancer or (b) Restful Movement (RM), a series of stretches and movements loosely based on the Lebed method of rehabilitation and lymphedema-preventative exercises for breast cancer patients, 30 participants in each group. The Restful Movement protocol will not be designed to emphasize movement of Qi (that is, will not include breath training nor teach about cultivating Qi, a central feature of Qigong practice). Primary endpoints will be assessed using (a) the Fatigue Sympton Inventory and FACT-COG and (b) objective measures of cognitive performance including Digit-Span and Letter/Number Sequencing tests of attention and working memory. Secondary measures include sleep quality, depression, and general quality of life. Specific Aim 1. To test whether Medical Qigong (MQ) practiced with conscious breathing techniques, visualization and intent to balance Qi is more effective than Restful Movement (RM) for improving symptoms in women after treatment for breast cancer. Hypothesis One: MQ will improve levels of fatigue in breast cancer survivors more than RM. Hypothesis two: MQ will improve cognitive function in breast cancer survivors more than RM. Specific Aim 2.To examine (a) mechanisms possibly associated with purported effects of MQ and (b) alternate explanations for effects. Blood analyses for all participants will examine lymphocyte counts, T cell subsets, and serum cytokines. If findings are positive, results will be used to plan an RO1 proposal to test Medical Qigong against both RM and a usual care control, powered for significance, including more extensive tests for mechanisms of action potentially influencing outcomes related to Qigong practice on fatigue, cognitive function and immune/inflammation markers, and track disease progression outcomes.