The HEALS Project - Health Education and Active Living for Surviving Seniors (HEALS)
|ClinicalTrials.gov Identifier: NCT01305044|
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivorship Safety and Efficacy Quality of Life||Behavioral: Tai Chi Chih Behavioral: Health Education Classes||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||November 2011|
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.).
Behavioral: Health Education Classes
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.
- Retention Rates and Class Attendance [ Time Frame: 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 [ Time Frame: 13 weeks ]The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
- Health-Related Quality of Life (Short Form (SF)-36v1) [ Time Frame: 13 weeks ]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.
- Perceived Stress Scale [ Time Frame: 13 weeks ]The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.
- Impact of Events Scale [ Time Frame: 13-weeks ]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.
- Pittsburgh Sleep Quality Index [ Time Frame: 13-weeks ]The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.
- Five-Facet Mindfulness Questionnaire [ Time Frame: 13-weeks ]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.
- Blood Pressure [ Time Frame: 13-weeks ]Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
- Cortisol Area-Under-Curve (AUC) [ Time Frame: 13-weeks ]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.
- Inflammatory Cytokines [ Time Frame: 13-weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305044
|United States, Utah|
|Huntsman Cancer Institute|
|Salt lake City, Utah, United States, 84112|
|Principal Investigator:||Anita Kinney||Huntsman Cancer Institute|