Cancer Survivorship, Quality of Life, Safety and Efficacy
Conditions
Keywords
tai chi, elderly cancer survivor, mind body intervention
Brief summary
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.
Interventions
BEHAVIORALTai 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.
BEHAVIORALHealth 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.
Sponsors
National Cancer Institute (NCI)
Huntsman Cancer Institute
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Able to speak and read English fluently, and understand informed consent. 4. Willing to: sign a medical record release form; to be randomized and willing to participate in classes and all baseline and follow-up appointments. 5. 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. 6. Does not currently practice in a regular on-going meditative or relaxation technique. 7. 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
1. 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. 2. 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. 3. Inability to pass the Folstein Mini Mental Status Exam (score \<23). 4. Unable to drive or secure transportation to complete all aspects of the study. 5. Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rates and Class Attendance | 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 | 13 weeks | The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Events Scale | 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 | 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 | 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. |
| Health-Related Quality of Life (Short Form (SF)-36v1) | 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. |
| Cortisol Area-Under-Curve (AUC) | 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 | 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. |
| Blood Pressure | 13-weeks | Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions. |
| Perceived Stress Scale | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Tai Chi Chih | Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 19 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Region of Enrollment United States | 32 participants | 31 participants | 63 participants |
| Sex: Female, Male Female | 32 Participants | 31 Participants | 63 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Retention Rates and Class Attendance
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)
Time frame: 13 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tai Chi Chih | Retention Rates and Class Attendance | Retention Rate | 91 percentage of participants |
| Tai Chi Chih | Retention Rates and Class Attendance | Class Attendance Rate | 79 percentage of participants |
| Health Education | Retention Rates and Class Attendance | Retention Rate | 81 percentage of participants |
| Health Education | Retention Rates and Class Attendance | Class Attendance Rate | 83 percentage of participants |
Primary
Satisfaction With the Randomized Controlled Trial
The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
Time frame: 13 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tai Chi Chih | Satisfaction With the Randomized Controlled Trial | 1.00 units on a scale |
| Health Education | Satisfaction With the Randomized Controlled Trial | 1.11 units on a scale |
Secondary
Blood Pressure
Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
Time frame: 13-weeks
Population: Please refer to power calculation detailed in Primary Outcome Measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tai Chi Chih | Blood Pressure | Systolic Blood Pressure | 119.0 mm Hg | Standard Error 2.8 |
| Tai Chi Chih | Blood Pressure | Diastolic Blood Pressure | 79.6 mm Hg | Standard Error 2.2 |
| Health Education | Blood Pressure | Systolic Blood Pressure | 132.5 mm Hg | Standard Error 3.1 |
| Health Education | Blood Pressure | Diastolic Blood Pressure | 79.7 mm Hg | Standard Error 2.4 |
Secondary
Cortisol Area-Under-Curve (AUC)
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.
Time frame: 13-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Chih | Cortisol Area-Under-Curve (AUC) | 24.6 nmol*hr/L | Standard Error 1.5 |
| Health Education | Cortisol Area-Under-Curve (AUC) | 29.9 nmol*hr/L | Standard Error 1.5 |
Secondary
Five-Facet Mindfulness Questionnaire
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.
Time frame: 13-weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tai Chi Chih | Five-Facet Mindfulness Questionnaire | Observing Subscale | 28.0 units on a scale |
| Tai Chi Chih | Five-Facet Mindfulness Questionnaire | Awareness Subscale | 20.0 units on a scale |
| Tai Chi Chih | Five-Facet Mindfulness Questionnaire | Total Mindfulness Score | 125.0 units on a scale |
| Tai Chi Chih | Five-Facet Mindfulness Questionnaire | Nonjudging Subscale | 24.0 units on a scale |
| Tai Chi Chih | Five-Facet Mindfulness Questionnaire | Describing Subscale | 26.0 units on a scale |
| Tai Chi Chih | Five-Facet Mindfulness Questionnaire | Nonreacting Subscale | 25.5 units on a scale |
| Health Education | Five-Facet Mindfulness Questionnaire | Describing Subscale | 30.0 units on a scale |
| Health Education | Five-Facet Mindfulness Questionnaire | Total Mindfulness Score | 136.5 units on a scale |
| Health Education | Five-Facet Mindfulness Questionnaire | Observing Subscale | 29.0 units on a scale |
| Health Education | Five-Facet Mindfulness Questionnaire | Nonreacting Subscale | 25.0 units on a scale |
| Health Education | Five-Facet Mindfulness Questionnaire | Awareness Subscale | 22.0 units on a scale |
| Health Education | Five-Facet Mindfulness Questionnaire | Nonjudging Subscale | 28.5 units on a scale |
Secondary
Health-Related Quality of Life (Short Form (SF)-36v1)
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.
Time frame: 13 weeks
Population: Please refer to power calculation detailed in Primary Outcome Measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tai Chi Chih | Health-Related Quality of Life (Short Form (SF)-36v1) | Mental Component Summary Score | 51.7 units on a scale | Standard Error 1.6 |
| Tai Chi Chih | Health-Related Quality of Life (Short Form (SF)-36v1) | Physical Component Summary Score | 41.3 units on a scale | Standard Error 1.4 |
| Health Education | Health-Related Quality of Life (Short Form (SF)-36v1) | Mental Component Summary Score | 51.0 units on a scale | Standard Error 1.6 |
| Health Education | Health-Related Quality of Life (Short Form (SF)-36v1) | Physical Component Summary Score | 43.2 units on a scale | Standard Error 1.5 |
Secondary
Impact of Events Scale
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.
Time frame: 13-weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tai Chi Chih | Impact of Events Scale | Avoidance Subscale | 13.0 units on a scale |
| Tai Chi Chih | Impact of Events Scale | Intrusion Subscale | 10.0 units on a scale |
| Tai Chi Chih | Impact of Events Scale | Total Score | 22.0 units on a scale |
| Health Education | Impact of Events Scale | Total Score | 19.0 units on a scale |
| Health Education | Impact of Events Scale | Intrusion Subscale | 9.0 units on a scale |
| Health Education | Impact of Events Scale | Avoidance Subscale | 11.0 units on a scale |
Secondary
Inflammatory Cytokines
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.
Time frame: 13-weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tai Chi Chih | Inflammatory Cytokines | IL-4 | 1.5 pg/ml |
| Tai Chi Chih | Inflammatory Cytokines | IL-10 | 5.8 pg/ml |
| Tai Chi Chih | Inflammatory Cytokines | IL-12 | 4.7 pg/ml |
| Tai Chi Chih | Inflammatory Cytokines | IL-6 | 9.1 pg/ml |
| Tai Chi Chih | Inflammatory Cytokines | TNF-α | 37.8 pg/ml |
| Health Education | Inflammatory Cytokines | TNF-α | 45.1 pg/ml |
| Health Education | Inflammatory Cytokines | IL-4 | 1.1 pg/ml |
| Health Education | Inflammatory Cytokines | IL-6 | 5.3 pg/ml |
| Health Education | Inflammatory Cytokines | IL-10 | 5.0 pg/ml |
| Health Education | Inflammatory Cytokines | IL-12 | 3.7 pg/ml |
Secondary
Perceived Stress Scale
The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tai Chi Chih | Perceived Stress Scale | 12.0 units on a scale |
| Health Education | Perceived Stress Scale | 13.0 units on a scale |
Secondary
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.
Time frame: 13-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tai Chi Chih | Pittsburgh Sleep Quality Index | 8.0 units on a scale |
| Health Education | Pittsburgh Sleep Quality Index | 10.0 units on a scale |