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

描述(申请人提供)：乳腺癌患者经常报告生活质量(QOL)方面的缺陷，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模式之一是以中医为基础的气功练习。我们建议测试一套医学气功练习对40-70岁的I期或II期乳腺癌疲惫幸存者的疲劳和其他症状的潜在影响。接受乳腺癌治疗6个月至5年并符合疲劳标准的患者将被随机分为两组，接受为期3个月的干预：(A)由东方医学博士/气功大师制定并指导、专门为乳腺癌康复女性患者设计的一系列温和的医学气功(MQ)练习；或(B)休息运动(RM)，一系列松散地基于Leed方法的伸展和运动，为乳腺癌患者提供康复和预防淋巴水肿的练习，每组30人。静息运动方案将不会被设计为强调气功的运动(也就是说，不会包括呼吸训练，也不会教授气功练习的核心特征--养气)。将使用(A)疲劳-辛普顿问卷和FACT-COG以及(B)认知表现的客观测量，包括注意力和工作记忆的数字广度和字母/数字排序测试来评估主要终点。次要指标包括睡眠质量、抑郁和总体生活质量。具体目的1.探讨运用有意识的呼吸技巧、直观性和意向性的医学气功(MQ)是否比静息运动(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。具体目的2.研究(A)可能与所谓的记忆商数效应相关的机制和(B)对效应的替代解释。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。如果结果是肯定的，结果将被用来计划RO1提案，以针对RM和常规护理对照来测试医学气功，并提供有意义的动力，包括对可能影响与气功练习有关的疲劳、认知功能和免疫/炎症标记物的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.