Clinical trial NCT01305044: The HEALS Project - Health Education and Active Living for Surviving Seniors
Official title: Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Survivorship
Safety and Efficacy
Quality of Life
Keywords: tai chi
elderly cancer survivor
mind body intervention
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Huntsman Cancer Institute
First posted: 2011-02-28
Enrollment: 63
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Retention Rates and Class Attendance
timeFrame: 13 weeks
measure: Satisfaction With the Randomized Controlled Trial
timeFrame: 13 weeks
Secondary outcomes:
measure: Health-Related Quality of Life (Short Form (SF)-36v1)
timeFrame: 13 weeks
measure: Perceived Stress Scale
timeFrame: 13 weeks
measure: Impact of Events Scale
timeFrame: 13-weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 13-weeks
measure: Five-Facet Mindfulness Questionnaire
timeFrame: 13-weeks
measure: Blood Pressure
timeFrame: 13-weeks
measure: Cortisol Area-Under-Curve (AUC)
timeFrame: 13-weeks
measure: Inflammatory Cytokines
timeFrame: 13-weeks
Other outcomes:
Locations:
city: Salt lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Anita Kinney
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.