Biobehavioral Effects of Tai Chi Chih Among Elderly Breast Cancer Survivors

描述（由申请人提供）：超过 120 万年龄在 65 岁及以上的美国女性是在 1 至 27 年前首次诊断出乳腺癌的幸存者。随着美国人口老龄化，这一数字预计还会增加。与从未患过癌症的老年人相比，短期和长期老年乳腺癌幸存者更有可能报告生活质量较差、心理困扰率较高、总体健康状况较差以及功能受限较多。身心锻炼干预措施已被建议作为改善正在接受或已完成治疗的癌症患者精神和身体方面生活质量的一种方法。太极拳（TCC）就是这样的干预措施之一。 TCC 是太极拳的西化版本，专为老年人和健康状况不佳的人群而设计。它被认为是一种中等强度的有氧运动，由缓慢、刻意的运动和冥想相结合。尽管太极拳在世界各地广泛流行，但其功效从未在老年乳腺癌幸存者中得到科学评估。我们的应用程序的主要目标是评估 TCC 的安全性和可行性，以及 TCC 对完成乳腺癌治疗的老年妇女的生活质量和身体机能的影响。探索性目的是评估干预措施对与肿瘤进展和生存相关的全身炎症和免疫系统失调的选定标志物的影响。这项 2 组试点随机试验将评估招募和保留率、不良事件、依从性、干预措施的实施和可接受性、纳入/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 年的时间内，60 名老年乳腺癌幸存者（其中 30 名随机接受 TCC，30 名接受健康教育对照组）将在一项为期 15 周的项目中进行比较。为了评估 TCC 对生活质量指标的影响，将在基线以及第 8、16 和 28 周时进行评估。身体表现和生物标志物（即 C 反应蛋白和 IL-6）将在第 16 周的基线进行。这项研究将提供关于 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的设计，以了解该干预措施的功效和生物心理社会机制。公共卫生相关性：65 岁以上的癌症幸存者人数众多，而且还在不断增长。现有数据表明，与患有其他部位癌症的女性和没有个人癌症史的女性相比，短期和长期女性乳腺癌幸存者报告了更多与力量和活动能力相关的限制。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。精神和身体干预措施的结合可能会显着改善生活质量。太极拳（TCC）是一种身心锻炼形式，就是这样的干预措施。 TCC 可能特别适合身体和/或精神功能受损的老年乳腺癌幸存者，但尽管它在健康和患病人群中越来越受欢迎和受益，但其益处从未在该人群中得到科学评估。这项研究的总体目标是就 TCC 对生活质量和身体功能的影响进行准备工作，这将为未来针对老年癌症幸存者进行 TCC 的最终试验奠定基础。作为这项为期 15 周试验的一部分，参与者将被随机分配到 TCC 组或健康教育对照组 (HEC)。建立有意义的干预措施以促进老年癌症生存体验更加积极是一个重要问题；如果 TC 干预在这一患者群体中取得成功，将会带来巨大的公共健康和临床效益。

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.