Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Retention Rates and Class Attendance
研究概览
简要总结
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 12-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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >/= 55 years and it has been three months or more (with the exception of hormone therapy) since completing treatment for breast or other solid tumor cancers (excluding lung, liver, pancreas and brain) and currently in remission.
- •Living within 30 miles of Huntsman Cancer Institute and has access to transportation and is willing to travel to the study site per study protocol; Travels independently on public transportation or drives own car.
- •Able to speak and read English fluently, and understand informed consent.
- •Willing to: sign a medical record release form; to be randomized and willing to participate in classes and all baseline and follow-up appointments.
- •Has some physical limitation as defined by a score of <72 in the Role Physical or <80 in the Physical Functioning sub-scales in the SF-12 screening questionnaire.
- •Does not currently practice in a regular on-going meditative or relaxation technique.
- •Does not currently engage in a regular, strenuous-intensity form of exercise for 30 min or more per day, 3 or more days per week.
排除标准
- •Engaged in focused intense physical activity for 30 minutes or more a day for 3 or more days a week for the previous 6 months as per responses on the screening telephone call.
- •Regular on-going practice with TC or other similar types of Complementary and Alternative Medicine in the past 6 months such as Qigong, meditation, relaxation, and yoga since these share some of the principles of TC.
- •Inability to pass the Folstein Mini Mental Status Exam (score <23).
- •Unable to drive or secure transportation to complete all aspects of the study.
- •Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention.
结局指标
主要结局
Retention Rates and Class Attendance
时间窗: 13 weeks
The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)
Satisfaction With the Randomized Controlled Trial
时间窗: 13 weeks
The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
次要结局
- Health-Related Quality of Life (Short Form (SF)-36v1)(13 weeks)
- Perceived Stress Scale(13 weeks)
- Impact of Events Scale(13-weeks)
- Pittsburgh Sleep Quality Index(13-weeks)
- Five-Facet Mindfulness Questionnaire(13-weeks)
- Blood Pressure(13-weeks)
- Cortisol Area-Under-Curve (AUC)(13-weeks)
- Inflammatory Cytokines(13-weeks)
研究者
Anita Kinney
Professor, Dept of Internal Medicine, University of Utah & Huntsman Cancer Insitute
University of Utah