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| ID | Type | Description | Link |
|---|---|---|---|
| R21 CA135250-2 | Other Grant/Funding Number | NCI | |
| R21CA135250 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Huntsman Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi Chih | Experimental | 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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| Health Education Classes | Active Comparator | 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.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi Chih | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 13 weeks |
| Satisfaction With the Randomized Controlled Trial | The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree). | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 weeks |
| Perceived Stress Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita Kinney | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23620504 | Result | Campo RA, O'Connor K, Light KC, Nakamura Y, Lipschitz DL, LaStayo PC, Pappas L, Boucher K, Irwin MR, Agarwal N, Kinney AY. Feasibility and acceptability of a Tai Chi Chih randomized controlled trial in senior female cancer survivors. Integr Cancer Ther. 2013 Nov;12(6):464-74. doi: 10.1177/1534735413485418. Epub 2013 Apr 25. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Number | percentage of participants | 13 weeks |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anita Kinney, PhD, RN | Huntsman Cancer Institute | 801-585-1151 | anita.kinney@hci.utah.edu |
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| Health Education Classes | Behavioral | 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. |
|
The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress. |
| 13 weeks |
| 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. | 13-weeks |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality. | 13-weeks |
| 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. | 13-weeks |
| Blood Pressure | Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions. | 13-weeks |
| 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. | 13-weeks |
| 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. | 13-weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | 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. |
|
|
| 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. | Please refer to power calculation detailed in Primary Outcome Measure. | Posted | Mean | Standard Error | units on a scale | 13 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 13 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 13-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 13-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 13-weeks |
|
|
|
| Secondary | Blood Pressure | Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions. | Please refer to power calculation detailed in Primary Outcome Measure. | Posted | Mean | Standard Error | mm Hg | 13-weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | nmol*hr/L | 13-weeks |
|
|
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| 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. | Posted | Median | Inter-Quartile Range | pg/ml | 13-weeks |
|
|
|
| Primary | Satisfaction With the Randomized Controlled Trial | The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree). | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 13 weeks |
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|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. | 0 | 31 | 0 | 31 |
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| Intrusion Subscale |
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| Describing Subscale |
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| Awareness Subscale |
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| Nonjudging Subscale |
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| Nonreacting Subscale |
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| TNF-α |
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| IL-4 |
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| IL-10 |
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