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

Completed · Phase 2

Conditions studied: Cancer Survivorship, Safety and Efficacy, Quality of Life

In brief

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.

Key facts

Study ID

NCT01305044

Run by

University of Utah

People needed

63

Starts

2009-12-01

Expected to finish

2011-11-01

Last updated by the study team

2015-12-14

Who can join

Age: 55 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Able to speak and read English fluently, and understand informed consent.
• Willing to: sign a medical record release form; to be randomized and willing to participate in classes and all baseline and follow-up appointments.
• 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.
• Does not currently practice in a regular on-going meditative or relaxation technique.
• 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.

You may not qualify if…

• 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.
• 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.
• Inability to pass the Folstein Mini Mental Status Exam (score <23).
• Unable to drive or secure transportation to complete all aspects of the study.
• Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention.

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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