Trial Outcomes & Findings for The HEALS Project - Health Education and Active Living for Surviving Seniors (NCT NCT01305044)
NCT ID: NCT01305044
Last Updated: 2015-12-14
Results Overview
The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
COMPLETED
PHASE2
63 participants
13 weeks
2015-12-14
Participant Flow
371 female cancer survivors with some functional limitations were recruited through Huntsman Cancer Institute registries and clinics, and community advertisements (media, newspapers). The first cohort of participants was held in the Spring 2010 with the second and third cohorts of participants held in the Fall 2010 and Spring 2011, respectively.
Forty percent (n=150) expressed an interest in participating and 42% who met eligibility (n=63) were randomized to receive 12-week (3 days/week) of TCC or Health Education Control (HEC) classes.
Participant milestones
| Measure |
Tai Chi Chih
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Tai Chi Chih
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
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
Baseline Characteristics
The HEALS Project - Health Education and Active Living for Surviving Seniors
Baseline characteristics by cohort
| Measure |
Tai Chi Chih
n=32 Participants
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
n=31 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: 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.
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)
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Retention Rates and Class Attendance
Retention Rate
|
91 percentage of participants
|
81 percentage of participants
|
|
Retention Rates and Class Attendance
Class Attendance Rate
|
79 percentage of participants
|
83 percentage of participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: 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.
The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Satisfaction With the Randomized Controlled Trial
|
1.00 units on a scale
Interval 0.78 to 1.2
|
1.11 units on a scale
Interval 1.0 to 1.6
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Please refer to power calculation detailed in Primary Outcome Measure.
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.
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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-Related Quality of Life (Short Form (SF)-36v1)
Mental Component Summary Score
|
51.7 units on a scale
Standard Error 1.6
|
51.0 units on a scale
Standard Error 1.6
|
|
Health-Related Quality of Life (Short Form (SF)-36v1)
Physical Component Summary Score
|
41.3 units on a scale
Standard Error 1.4
|
43.2 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 13 weeksThe 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Perceived Stress Scale
|
12.0 units on a scale
Interval 5.0 to 17.0
|
13.0 units on a scale
Interval 7.0 to 17.0
|
SECONDARY outcome
Timeframe: 13-weeksThe 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.
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Impact of Events Scale
Total Score
|
22.0 units on a scale
Interval 18.0 to 26.0
|
19.0 units on a scale
Interval 15.0 to 28.0
|
|
Impact of Events Scale
Avoidance Subscale
|
13.0 units on a scale
Interval 11.0 to 17.0
|
11.0 units on a scale
Interval 8.0 to 14.0
|
|
Impact of Events Scale
Intrusion Subscale
|
10.0 units on a scale
Interval 7.0 to 11.0
|
9.0 units on a scale
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: 13-weeksThe Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
|
8.0 units on a scale
Interval 6.0 to 11.0
|
10.0 units on a scale
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: 13-weeksThe 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.
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Five-Facet Mindfulness Questionnaire
Total Mindfulness Score
|
125.0 units on a scale
Interval 108.2 to 137.8
|
136.5 units on a scale
Interval 114.5 to 152.2
|
|
Five-Facet Mindfulness Questionnaire
Observing Subscale
|
28.0 units on a scale
Interval 16.0 to 32.0
|
29.0 units on a scale
Interval 25.0 to 35.0
|
|
Five-Facet Mindfulness Questionnaire
Describing Subscale
|
26.0 units on a scale
Interval 23.0 to 30.0
|
30.0 units on a scale
Interval 24.0 to 34.0
|
|
Five-Facet Mindfulness Questionnaire
Awareness Subscale
|
20.0 units on a scale
Interval 16.0 to 22.0
|
22.0 units on a scale
Interval 17.0 to 26.0
|
|
Five-Facet Mindfulness Questionnaire
Nonjudging Subscale
|
24.0 units on a scale
Interval 17.0 to 30.0
|
28.5 units on a scale
Interval 24.7 to 31.2
|
|
Five-Facet Mindfulness Questionnaire
Nonreacting Subscale
|
25.5 units on a scale
Interval 21.7 to 29.0
|
25.0 units on a scale
Interval 21.0 to 29.0
|
SECONDARY outcome
Timeframe: 13-weeksPopulation: Please refer to power calculation detailed in Primary Outcome Measure.
Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
Outcome measures
| Measure |
Tai Chi Chih
n=29 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Blood Pressure
Systolic Blood Pressure
|
119.0 mm Hg
Standard Error 2.8
|
132.5 mm Hg
Standard Error 3.1
|
|
Blood Pressure
Diastolic Blood Pressure
|
79.6 mm Hg
Standard Error 2.2
|
79.7 mm Hg
Standard Error 2.4
|
SECONDARY outcome
Timeframe: 13-weeksFive 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.
Outcome measures
| Measure |
Tai Chi Chih
n=20 Participants
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
n=19 Participants
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.
|
|---|---|---|
|
Cortisol Area-Under-Curve (AUC)
|
24.6 nmol*hr/L
Standard Error 1.5
|
29.9 nmol*hr/L
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 13-weeksFasting 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.
Outcome measures
| Measure |
Tai Chi Chih
n=28 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Inflammatory Cytokines
IL-12
|
4.7 pg/ml
Interval 3.3 to 12.5
|
3.7 pg/ml
Interval 1.3 to 7.4
|
|
Inflammatory Cytokines
IL-6
|
9.1 pg/ml
Interval 4.3 to 29.0
|
5.3 pg/ml
Interval 3.4 to 8.2
|
|
Inflammatory Cytokines
TNF-α
|
37.8 pg/ml
Interval 0.0 to 77.9
|
45.1 pg/ml
Interval 0.0 to 109.1
|
|
Inflammatory Cytokines
IL-4
|
1.5 pg/ml
Interval 0.6 to 3.6
|
1.1 pg/ml
Interval 0.5 to 2.2
|
|
Inflammatory Cytokines
IL-10
|
5.8 pg/ml
Interval 4.3 to 16.3
|
5.0 pg/ml
Interval 2.9 to 7.7
|
Adverse Events
Tai Chi Chih
Health Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place