Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors

 描述（由申请人提供）：乳腺癌患者经常报告疲劳和其他相关症状，在治疗结束后持续数月，甚至数年。在最近的可行性试点研究气功/太极容易（QG/TCE），乳腺癌幸存者经历了显着更大的改善疲劳和改善趋势相比，假气功控制睡眠质量，抑郁症和认知功能.基于这项研究的承诺，并进一步测试干预成分，可能阐明干预的哪些方面具有最大的影响，我们提出了一个三组，随机试验，以测试12周QG/TCE干预对疲劳和其他症状的影响，在12周结束时，并再次在36周。我们将246名年龄在45-75岁、绝经后、0- III期乳腺癌治疗后6个月至5年的女性随机分为三个研究组。将使用QG/TCE的两个比较组：教育支持（ES）组控制和主动锻炼（假气功，“SQG”），其运动类似于QG/TCE，但不关注呼吸和冥想状态。本研究的目的是测试QG/TCE是否比a）基于非冥想的SQG干预和B）无运动，教育/社会支持（ES）干预更有效，以改善乳腺癌治疗后女性的疲劳和其他症状-睡眠质量，焦虑，抑郁和认知功能。基于一个正在进行中的小型试点项目和先前的轶事报告，我们还将探讨QG/TCE是否比对照干预措施更能改善BCS患者的周围神经病变症状。最后，我们将检查一组参与者的生物标志物，包括唾液皮质醇和一组候选的促炎细胞因子，选择有一些证据表明对QG/TCE样实践的反应和与疲劳相关，以探索干预效果对结果的可能机制。

 DESCRIPTION (provided by applicant): Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent feasibility pilot study of Qigong/Tai Chi Easy (QG/TCE), breast cancer survivors experienced significantly greater improvements in fatigue and trends for improvement compared to a sham Qigong control for sleep quality, depression and cognitive function. To build upon the promise of this study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, we propose a three-group, randomized trial to test effects of a 12 week QG/TCE intervention on fatigue and other symptoms at the end of 12 weeks, and again at 36 weeks. We will randomize 246 women; 6 months to 5 years past treatment for Stage 0- III breast cancer, aged 45-75, post-menopausal into one of three study arms. Two comparison groups to the QG/TCE will be used: an educational support (ES) group control and an active exercise (sham Qigong, "SQG") with movements that are similar to QG/TCE, but without the focus on the breath and meditative state. The aim of this study is to test whether QG/TCE is more efficacious than a) a non-meditation based SQG intervention and b) a no-exercise, education/social support (ES) intervention for improving fatigue and other symptoms -- sleep quality, anxiety, depression, and cognitive function--in women after treatment for breast cancer. Based on a small pilot project in progress and prior anecdotal reports, we will also explore whether QG/TCE improves symptoms of peripheral neuropathy among BCSs more than comparison interventions. Finally, we will examine a set of participants' biomarkers, including salivary cortisol and a set of candidate pro-inflammatory cytokines, selected as having some evidence for responding to QG/TCE-like practices and for being associated with fatigue, to explore possible mechanisms of the intervention effects on outcomes.