Biobehavioral Effects of Tai Chi Chih Among Elderly Breast Cancer Survivors

描述（由申请人提供）：超过120万65岁及以上的美国女性是乳腺癌幸存者，最初诊断为1至27年前。随着美国人口老龄化，这一数字预计将增加。与从未患过癌症的老年人相比，短期和长期的老年乳腺癌幸存者更有可能报告生活质量较差，心理困扰率高，总体健康状况较差和更多的功能限制。身心锻炼干预已被建议作为一种方法，以改善正在接受或已完成治疗的癌症患者的生活质量的精神和身体方面。太极拳（TCC）就是这样一种干预。TCC是太极拳的西方版本，专为老年人和医疗受损人群设计。它被认为是一种中等强度的有氧运动，由缓慢、深思熟虑的动作和冥想相结合组成。尽管太极拳在世界各地广泛流行，但其疗效从未在老年乳腺癌幸存者中进行过科学评估。我们的申请的主要目的是评估TCC的安全性和可行性，以及TCC对已完成乳腺癌治疗的老年女性的生活质量和身体功能的影响。探索性目的是评估干预对与肿瘤进展和生存相关的全身性炎症和免疫系统失调的选择标志物的影响。这项2组初步随机试验将评价招募率和保留率、不良事件、依从性、干预措施的实施和可接受性、入选/排除标准的适当性以及计划的大型临床试验的总体方案设计的优化。在为期2年的时间里，60名老年乳腺癌幸存者（30名随机分配到TCC组，30名随机分配到健康教育对照组）将在一个为期15周的项目中进行比较。为了评价TCC对生活质量指标的影响，将在基线和第8、16和28周进行评估。体能和生物标志物（即，C-反应蛋白和IL-6）将在第16周基线时进行。这项研究将提供有关TCC在老年乳腺癌幸存者中的潜在可接受性和安全性以及初步疗效的初步数据，并将有助于指导未来大规模研究这种干预措施的疗效和生物心理社会机制的设计。公共卫生相关性：65岁以上的人构成了癌症幸存者的一个庞大且不断增长的人口。现有数据表明，短期和长期女性乳腺癌幸存者报告的与其他部位癌症患者和没有个人癌症史的妇女相比，在力量和行动能力方面的限制更多。此外，乳腺癌幸存者更好的心理健康已被证明可以防止身体衰退和整体生活质量。心理和身体干预的结合可能会导致生活质量的大幅改善。太极拳（TCC），一种身心锻炼的形式，就是这样一种干预。TCC可能特别适合于身体和/或精神功能受损的老年乳腺癌幸存者，尽管其在健康和患病人群中越来越受欢迎和有益，但其益处从未在该人群中进行过科学评估。本研究的总体目标是进行准备工作，关于TCC对生活质量和身体功能的影响，这将支持未来在老年癌症幸存者中进行TCC的最终试验。作为这项为期15周的试验的一部分，参与者将被随机分配到TCC或健康教育对照组（HEC）。建立有意义的干预措施，促进老年人更积极的癌症生存经验是一个重要的问题;如果TC干预在这一患者人群中取得成功，则会带来实质性的公共卫生和临床益处。

DESCRIPTION (provided by applicant): More than 1.2 million U.S. women age 65 years and older are breast cancer survivors with initial diagnosis from 1 to 27 years ago. This figure is expected to increase as the U.S. population ages. Compared to elderly individuals who have never had cancer, both short-term and long-term elderly breast cancer survivors are more likely to report worse quality of life, high rates of psychological distress, poorer general health status, and more functional limitations. Mind-body exercise interventions have been suggested as a way to improve both mental and physical aspects of quality of life in cancer patients who are undergoing or who have completed treatment. Tai Chi Chih (TCC) is one such intervention. TCC is a westernized version of Tai Chi Chuan that was designed for use in the elderly and medically compromised populations. It is considered to be a moderate- intensity aerobic exercise that consists of a combination of slow, deliberate movements and meditation. Despite the widespread popularity of Tai Chi throughout the world, its efficacy has never been scientifically evaluated in elderly breast cancer survivors. Our application has the primary objectives of evaluating the safety and feasibility, as well as the impact of TCC, on quality of life and physical functioning among elderly women who have completed treatment for breast cancer. An exploratory aim is to assess the impact of the intervention on select markers of systemic inflammation and immune system dysregulation that are associated with tumor progression and survival. This 2-arm pilot randomized trial will evaluate recruitment and retention rates, adverse events, compliance, delivery and acceptability of the intervention, appropriateness of inclusion/exclusion criteria, and optimization of the overall protocol design for the planned larger clinical trial. Over a 2-year period, 60 elderly breast cancer survivors (30 randomized to TCC and 30 to a health education control arm) will be compared in a 15-week program. To evaluate the effects of TCC on quality of life indicators, assessments will be done at baseline and at 8, 16, and 28 weeks. Physical performance and biomarker (i.e., C-reactive protein and IL-6) will be done at baseline at Week 16. This study will provide preliminary data on the potential acceptability and safety as well as initial efficacy of TCC among elderly breast cancer survivors and will help guide the design of a future large-scale study of the efficacy and biopsychosocial mechanisms of this intervention. PUBLIC HEALTH RELEVANCE: Persons over age 65 years constitute a large and growing population of cancer survivors. Available data indicate that both short- and long-term female breast cancer survivors report more limitations related to strength and mobility than women with cancers of other sites and women without a personal history of cancer. Further, better mental health among breast cancer survivors has been shown to protect against physical decline and overall quality of life. The combination of mental and physical interventions may result in substantial improvements in quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention. TCC may be particularly suited toward elderly breast cancer survivors with impaired physical and/or mental functioning, yet despite its increasing popularity and benefits in healthy and diseased populations, its benefits have never been scientifically evaluated in this population. The overarching goal of this study is to conduct preparatory work regarding the effects of TCC on quality of life and physical function that will underpin future definitive trials of TCC in elderly cancer survivors. As part of this 15-week trial, participants will be randomized to a TCC or a health education control group (HEC). Establishment of meaningful interventions that facilitate a more positive cancer survival experience in old age is an important issue; there are substantial public health and clinical benefits should a TC intervention be successful in this patient population.