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

 描述(申请人提供)：乳腺癌患者经常报告疲倦和其他相关症状，在治疗结束后持续数月，甚至数年。在最近的一项气功/太极简易(QG/TCE)可行性初步研究中，与假气功对照相比，乳腺癌幸存者在疲劳和改善趋势方面体验到了显著的改善，睡眠质量、抑郁和认知功能。为了建立在这项研究的基础上，并进一步测试干预成分，以阐明干预的哪些方面具有最大的影响，我们提出了一项三组随机试验，以测试12周的QG/TCE干预在12周结束时对疲劳和其他症状的效果，并在36周时再次测试。我们将246名绝经后0-III期乳腺癌治疗6个月至5年后的女性随机分为三组。QG/TCE的两个对照组将被使用：教育支持组(ES)对照组和积极运动(假气功，“SQG”)，动作类似QG/TCE，但不关注呼吸和冥想状态。这项研究的目的是测试QG/TCE是否比a)基于非冥想的SQG干预和b)不锻炼、教育/社会支持(ES)干预在改善乳腺癌治疗后妇女的疲劳和其他症状--睡眠质量、焦虑、抑郁和认知功能--方面更有效。基于一个正在进行的小型试验项目和之前的轶事报道，我们还将探索QG/TCE是否比对照干预更能改善BCS中的周围神经病症状。最后，我们将检查一组参与者的生物标记物，包括唾液皮质醇和一组候选的促炎细胞因子，被选为对QG/TCE样练习有反应和与疲劳相关的一些证据，以探索干预对结果影响的可能机制。

 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.