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.
|Effective start/end date||8/10/09 → 7/31/12|
- National Institutes of Health: $231,641.00
- National Institutes of Health: $297,990.00