The HEALS Project - Health Education and Active Living for Surviving Seniors
HEALS
Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · NCI
NIH
interventional
63
1 country
1
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
November 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
February 18, 2011
Actual (reported)February 28, 2011
Actual (reported)September 2011
Actual (reported)November 2011
Actual (reported)December 14, 2015
Actual (reported)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
Health-Related Quality of Life (Short Form (SF)-36v1)
13 weeks
Perceived Stress Scale
13 weeks
Impact of Events Scale
13-weeks
Pittsburgh Sleep Quality Index
13-weeks
Five-Facet Mindfulness Questionnaire
13-weeks
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.
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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.
Anita Kinney
Huntsman Cancer Institute
63 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2011
First Posted
February 28, 2011
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
December 14, 2015
Results First Posted
December 14, 2015
Record last verified: 2015-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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