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

NCT01305044 | Completed Phase 2 Results DMC

• 3 other identifiers: 34851R21 CA135250-2R21CA135250
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivorship; Safety and Efficacy; Quality of Life

Keywords

tai chi; elderly cancer survivor; mind body intervention

Outcome Measures

Primary Outcomes (2)

• 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

• Satisfaction With the Randomized Controlled Trial

  The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).

  13 weeks

Secondary Outcomes (8)

• Health-Related Quality of Life (Short Form (SF)-36v1)

  13 weeks

• Perceived Stress Scale

  13 weeks

• Impact of Events Scale

  13-weeks

• Pittsburgh Sleep Quality Index

  13-weeks

• Five-Facet Mindfulness Questionnaire

  13-weeks

Study Arms (2)

Tai Chi Chih

EXPERIMENTAL

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

Health Education Classes

ACTIVE COMPARATOR

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

Interventions

Tai Chi Chih BEHAVIORAL

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.

Tai Chi Chih

Health Education Classes BEHAVIORAL

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.

Health Education Classes

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator
• Huntsman Cancer Institute: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related 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. 2013 Nov;12(6):464-74. doi: 10.1177/1534735413485418. Epub 2013 Apr 25.

  PMID: 23620504 RESULT

Results Point of Contact

• Title: Anita Kinney, PhD, RN
• Organization: Huntsman Cancer Institute

anita.kinney@hci.utah.edu

801-585-1151

Study Officials

• Anita Kinney

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept of Internal Medicine, University of Utah & Huntsman Cancer Insitute

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 28, 2011
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

US (1)