The HEALS Project - Health Education and Active Living for Surviving Seniors
Condition: Cancer Survivorship; Safety and Efficacy; Quality of Life
Intervention: Tai Chi Chih; Health Education Classes
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: tai chi; elderly cancer survivor; mind body intervention

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.