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

This study has been completed.
Sponsor:
Collaborators:
Huntsman Cancer Institute
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01305044
First received: February 18, 2011
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Cancer Survivorship
Safety and Efficacy
Quality of Life
Behavioral: Tai Chi Chih
Behavioral: Health Education Classes
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Determine the safety and feasibility of conducting a randomized controlled trial of TCC in sedentary elderly female breast and other solid tumor cancer survivors [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Determine the safety and feasibility of conducting a randomized controlled trial of TCC in sedentary elderly female breast and other solid tumor cancer survivors [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Determine the safety and feasibility of conducting a randomized controlled trial of TCC in sedentary elderly female breast and other solid tumor cancer survivors [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Determine the safety and feasibility of conducting a randomized controlled trial of TCC in sedentary elderly female breast and other solid tumor cancer survivors [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the preliminary efficacy of a TCC intervention vs. a health education control (HEC) condition on health related QOL (i.e., SF-36), QOL indices (i.e., sleep, cancer-specific distress, stress perceptions, and mindfulness)and physical performance [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Evaluate the preliminary efficacy of a TCC intervention vs. a health education control (HEC) condition on biomarkers associated with stress, breast cancer survival and overall survival. [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Evaluate the preliminary efficacy of a TCC intervention vs. a health education control (HEC) condition on health related QOL (i.e., SF-36), QOL indices (i.e., sleep, cancer-specific distress, stress perceptions, and mindfulness)and physical performance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluate the preliminary efficacy of a TCC intervention vs. a health education control (HEC) condition on health related QOL (i.e., SF-36), QOL indices (i.e., sleep, cancer-specific distress, stress perceptions, and mindfulness)and physical performance [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Evaluate the preliminary efficacy of a TCC intervention vs. a health education control (HEC) condition on biomarkers associated with stress, breast cancer survival and overall survival. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Evaluate the preliminary efficacy of a TCC intervention vs. a health education control (HEC) condition on health related QOL (i.e., SF-36), QOL indices (i.e., sleep, cancer-specific distress, stress perceptions, and mindfulness)and physical performance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tai Chi Chih Behavioral: 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.
Active Comparator: Health Education Behavioral: Health 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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305044

Locations
United States, Utah
Huntsman Cancer Institute
Salt lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Huntsman Cancer Institute
Investigators
Principal Investigator: Anita Kinney Huntsman Cancer Institute
  More Information

No publications provided

Responsible Party: Anita Kinney, Professor, Dept of Internal Medicine, University of Utah & Huntsman Cancer Insitute, University of Utah
ClinicalTrials.gov Identifier: NCT01305044     History of Changes
Other Study ID Numbers: 34851, R21 CA135250-2
Study First Received: February 18, 2011
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
tai chi
elderly cancer survivor
mind body intervention

ClinicalTrials.gov processed this record on September 18, 2014