The HEALS Project - Health Education and Active Living for Surviving Seniors (HEALS)
2015年11月9日 更新者：Anita Kinney、University of Utah
Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors
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.
研究概览
研究类型
介入性
注册 (实际的)
63
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Utah
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Salt lake City、Utah、美国、84112
- Huntsman Cancer Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Tai Chi Chih
The Tai Chi Chih classes were 60 minutes sessions, held three times a week, over twelve weeks.
The classes were led by an instructor who was certified and licensed in the Tai Chi Chih form.
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Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion.
This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control.
TCC was developed for use with elderly persons.
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有源比较器：Health Education Classes
Health Education classes were 60 minute sessions that occurred three times a week, over twelve weeks.
These classes were taught by specialists in the class topic and focused on topics related to aging (e.g., sleep quality, nutrition, pain, etc.).
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The Health Education classes serve as an attention control group, are led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Retention Rates and Class Attendance
大体时间：13 weeks
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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)
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13 weeks
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Satisfaction With the Randomized Controlled Trial
大体时间：13 weeks
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The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
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13 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health-Related Quality of Life (Short Form (SF)-36v1)
大体时间：13 weeks
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SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100.
Higher scores indicate better quality of life.
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13 weeks
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Perceived Stress Scale
大体时间：13 weeks
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The 10-item perceived stress scale produces a summation score.
Scores can range from 0 to 40, with higher scores indicating more stress.
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13 weeks
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Impact of Events Scale
大体时间：13-weeks
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The Impact of Event Scale assesses cancer-specific distress.
Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact.
It has a total score and two subscales (avoidance & intrusion).
The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales.
The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40.
The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.
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13-weeks
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Pittsburgh Sleep Quality Index
大体时间：13-weeks
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The Pittsburgh Sleep Quality produces a global score.
The range is 0 to 21, higher scores indicate worse sleep quality.
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13-weeks
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Five-Facet Mindfulness Questionnaire
大体时间：13-weeks
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The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity).
These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35).
Higher scores indicate more mindfulness.
The Total Score ranges from 39-195, with higher scores indicating more mindfulness.
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13-weeks
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Blood Pressure
大体时间：13-weeks
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Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
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13-weeks
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Cortisol Area-Under-Curve (AUC)
大体时间：13-weeks
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Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion.
Cortisol was measured in nmol/L.
Cortisol AUC was calculated using the five timepoints with the trapezoid rule.
The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means.
Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.
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13-weeks
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Inflammatory Cytokines
大体时间：13-weeks
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Fasting blood samples were collected in the morning for inflammatory cytokines.
Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw.
The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.
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13-weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anita Kinney、Huntsman Cancer Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年12月1日
初级完成 (实际的)
2011年9月1日
研究完成 (实际的)
2011年11月1日
研究注册日期
首次提交
2011年2月18日
首先提交符合 QC 标准的
2011年2月24日
首次发布 (估计)
2011年2月28日
研究记录更新
最后更新发布 (估计)
2015年12月14日
上次提交的符合 QC 标准的更新
2015年11月9日
最后验证
2015年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 34851
- R21 CA135250-2 (其他赠款/资助编号：NCI)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.