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The HEALS Project - Health Education and Active Living for Surviving Seniors (HEALS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305044
First Posted: February 28, 2011
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Huntsman Cancer Institute
Information provided by (Responsible Party):
Anita Kinney, University of Utah
Results First Submitted: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Cancer Survivorship
Safety and Efficacy
Quality of Life
Interventions: Behavioral: Tai Chi Chih
Behavioral: Health Education Classes

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Tai Chi Chih   Health Education
STARTED   32   31 
COMPLETED   29   25 
NOT COMPLETED   3   6 
Withdrawal by Subject                3                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Tai Chi Chih   Health Education   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   31   63 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   12   24 
>=65 years   20   19   39 
Gender 
[Units: Participants]
     
Female   32   31   63 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   32   31   63 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Retention Rates and Class Attendance   [ Time Frame: 13 weeks ]

2.  Primary:   Satisfaction With the Randomized Controlled Trial   [ Time Frame: 13 weeks ]

3.  Secondary:   Health-Related Quality of Life (Short Form (SF)-36v1)   [ Time Frame: 13 weeks ]

4.  Secondary:   Perceived Stress Scale   [ Time Frame: 13 weeks ]

5.  Secondary:   Impact of Events Scale   [ Time Frame: 13-weeks ]

6.  Secondary:   Pittsburgh Sleep Quality Index   [ Time Frame: 13-weeks ]

7.  Secondary:   Five-Facet Mindfulness Questionnaire   [ Time Frame: 13-weeks ]

8.  Secondary:   Blood Pressure   [ Time Frame: 13-weeks ]

9.  Secondary:   Cortisol Area-Under-Curve (AUC)   [ Time Frame: 13-weeks ]

10.  Secondary:   Inflammatory Cytokines   [ Time Frame: 13-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anita Kinney, PhD, RN
Organization: Huntsman Cancer Institute
phone: 801-585-1151
e-mail: anita.kinney@hci.utah.edu


Publications of Results:

Responsible Party: Anita Kinney, University of Utah
ClinicalTrials.gov Identifier: NCT01305044     History of Changes
Other Study ID Numbers: 34851
R21 CA135250-2 ( Other Grant/Funding Number: NCI )
First Submitted: February 18, 2011
First Posted: February 28, 2011
Results First Submitted: March 13, 2013
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015