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

Quality of Life Clinical Trial

— HEALS  

Official title:

Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305044
• Other study ID #: 34851
• Secondary ID: R21 CA135250-2
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2011
• Last updated: November 9, 2015
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer Survivorship
• Quality of Life
• Safety and Efficacy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Huntsman Cancer Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	13 weeks	Yes
Primary	Satisfaction With the Randomized Controlled Trial	The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).	13 weeks	No
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.	13 weeks	No
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.	13 weeks	No
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.	13-weeks	No
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.	13-weeks	No
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.	13-weeks	No
Secondary	Blood Pressure	Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.	13-weeks	No
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.	13-weeks	No
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)-a, and anti-inflammatory cytokines IL-10 and IL-4.	13-weeks	No