Biobehavioral Effects of Tai Chi Chih Among Elderly Breast Cancer Survivors

太极拳对老年乳腺癌幸存者生物行为的影响

• 批准号: 7662806
• 负责人: Anita Y. Kinney
• 金额: $ 29.8万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-10 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7662806
• 关键词: Adherence; Adverse event; Aerobic Exercise; Age; Biological Markers; Breast; Breast Cancer Treatment; C-reactive protein; Cancer Patient; Cancer Survivor; Chronic Disease; Clinical; Clinical Trials; Communities; Control Groups; Data; Data Collection; Diagnosis; Disease; Distress; Drops; Elderly; Elderly woman; Evaluation; Exclusion Criteria; Exercise; Face; Fatigue; Female Breast Carcinoma; Future; Goals; Health Status; Health education; Immune system; Individual; Inflammation; Inflammatory; Interleukin-6; Intervention; Lead; Malignant Neoplasms; Measures; Medical; Meditation; Mental Health; Movement; Outcome Measure; Outcome Study; Participant; Perception; Performance; Persons; Physical Fitness; Physical Function; Population; Preparation; Procedures; Protocols documentation; Psyche structure; Psychoneuroimmunology; Public Health; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recording of previous events; Relative (related person); Reporting; Research Design; SF-36; Safety; Sampling; Site; Sleep; Staging; Stress; Survival Rate; Survivors; Tai Ji; Testing; Upper arm; Withholding Treatment; Woman; Work; biobehavior; biopsychosocial; body-mind; design; efficacy trial; experience; fitness; health related quality of life; human old age (65+); improved; indexing; malignant breast neoplasm; mindfulness; patient population; pilot trial; post intervention; primary outcome; programs; psychological distress; psychosocial; public health relevance; satisfaction; sedentary; trend; tumor progression; week trial

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.

描述（由申请人提供）：超过120万65岁及以上的美国女性是1至27年前首次诊断的乳腺癌幸存者。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，短期和长期的老年乳腺癌幸存者更有可能报告生活质量更差，心理困扰率更高，一般健康状况更差，功能限制更多。身心运动干预被认为是一种改善正在接受或已完成治疗的癌症患者精神和身体生活质量的方法。太极（TCC）就是这样一种干预。太极拳是太极拳的西化版本，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、刻意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。我们的应用的主要目的是评估安全性和可行性，以及TCC对完成乳腺癌治疗的老年妇女的生活质量和身体功能的影响。一个探索性的目的是评估干预对与肿瘤进展和生存相关的系统性炎症和免疫系统失调的选择标志物的影响。这项两组随机试验将评估招募率和保留率、不良事件、依从性、干预措施的实施和可接受性、纳入/排除标准的适当性，以及计划进行的更大规模临床试验的总体方案设计的优化。在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。为了评估TCC对生活质量指标的影响，将在基线、8周、16周和28周进行评估。物理性能和生物标志物（即c -反应蛋白和IL-6）将在第16周基线时进行。本研究将为老年乳腺癌幸存者TCC的潜在可接受性、安全性和初步疗效提供初步数据，并将有助于指导未来大规模研究TCC的疗效和生物心理社会机制的设计。公共卫生相关性：65岁以上的人构成了一个庞大且不断增长的癌症幸存者群体。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病史的女性相比，短期和长期女性乳腺癌幸存者报告的力量和活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。精神和身体干预相结合可能会大大改善生活质量。太极拳（TCC）是一种身心锻炼形式，就是这样一种干预。TCC可能特别适用于身体和/或精神功能受损的老年乳腺癌幸存者，然而，尽管TCC在健康和患病人群中越来越受欢迎和有益，但其益处从未在这类人群中得到科学评估。本研究的总体目标是开展关于TCC对生活质量和身体功能影响的准备工作，这将为未来老年癌症幸存者中TCC的最终试验奠定基础。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组或健康教育对照组（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历是一个重要问题；如果在这一患者群体中成功实施TC干预，将会带来巨大的公共卫生和临床效益。