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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Huntsman Cancer Institute
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01305044
First received: February 18, 2011
Last updated: November 9, 2015
Last verified: November 2015
  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:
  • Retention Rates and Class Attendance [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).


Secondary Outcome Measures:
  • Health-Related Quality of Life (Short Form (SF)-36v1) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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.

  • Perceived Stress Scale [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.

  • Impact of Events Scale [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.

  • Five-Facet Mindfulness Questionnaire [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    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.

  • Blood Pressure [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.

  • Cortisol Area-Under-Curve (AUC) [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 13-weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
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
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.
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 Classes
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.).
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
National Cancer Institute (NCI)
Huntsman Cancer Institute
Investigators
Principal Investigator: Anita Kinney Huntsman Cancer Institute
  More Information

Publications:
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
Results First Received: March 13, 2013
Last Updated: November 9, 2015
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 May 26, 2016