Behaviors and Mental Disorders

All Conditions

Quality of Life

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.

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.).

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.

Tai Chi Chih

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.

Health Education Classes

Anita Kinney

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.

The HEALS Project - Health Education and Active Living for Surviving Seniors

Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors

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)

The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).

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.

The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.

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.

The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.

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.

Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.

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.

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.

National Cancer Institute (NCI)

Huntsman Cancer Institute

University of Utah

Professor, Dept of Internal Medicine, University of Utah & Huntsman Cancer Insitute

Tai Chi Chih : 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.

Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.

Health Education

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Anita Kinney, PhD, RN

Retention Rate

Class Attendance Rate

Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The HEALS Project - Health Education and Active Living for Surviving Seniors	NCT01305044	Cancer Survivor... Safety and Effi... Quality of Life	Tai Chi Chih Health Educatio...	55 Years - 90 Years	University of Utah
The HEALS Project - Health Education and Active Living for Surviving Seniors	NCT01305044	Cancer Survivor... Safety and Effi... Quality of Life	Tai Chi Chih Health Educatio...	55 Years - 90 Years	University of Utah

Spots Global Cancer Trial Database for elderly cancer survivor