Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms - Full Text View

Sponsored by:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00690196

Purpose

Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. We have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.

Condition	Intervention
Sleep Disorders Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases	Behavioral: Tai Chi Chih Behavioral: Cognitive Behavioral Therapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mental Health Neurologic Diseases Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Changes in insomnia symptoms as measured by subjective report and objective polysomnography; Changes in daytime impairment secondary to insomnia; Changes in fatigue, depression and mood, and health function [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in measure of proinflammatory cytokines activity; Changes in sympathovagal function and energy balance; Changes in measures of interpersonal resilience and social functioning [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tai Chi Chih	Behavioral: Tai Chi Chih Tai Chi Chih (TCC) employs "meditation through movement" as a means of helping breast cancer survivors cope with fatigue, perceived physical limitations, and negative emotional states which are commonly associated with insomnia. In groups of 7-8, subjects will learn to perform 20 movements under the guidance of expert TCC teacher (K. Hollister, certified instructor) who will oversee treatment sessions throughout the 12 week treatment, consistent with our preliminary studies (9). Sessions will be taught over 120 minutes with 90 minutes of active TCC, 20 minutes of warm-up (e.g., stretching, breathing),10 minutes of cool down. Sessions will be mainly given in the late afternoon at 16:00 h. Thus, the TCC will be given once a week per week for a total of 120 minutes, similar in total time allocation with Cognitive Behavioral Therapy. The final week of treatment will include the development of a TCC adherence plan to ensure continuity of practice and skill maintenance during follow-up.
2: Active Comparator Cognitive Behavioral Therapy	Behavioral: Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) for insomnia will be supervised by a Ph.D. level psychologist, with specialty training in behavior therapy and behavioral medicine. The CBT sessions will be held once a week for 120 minutes (each session) over the 12-week treatment period, identical to the time schedule which was to be used for health education. Treatment will be given in small groups of 7-8 subjects. The content of the intervention will be organized around a series of modules that will be presented to patients in manualized form. For each session, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.

Arms

Assigned Interventions

1: Experimental

Tai Chi Chih

Behavioral: Tai Chi Chih

Tai Chi Chih (TCC) employs "meditation through movement" as a means of helping breast cancer survivors cope with fatigue, perceived physical limitations, and negative emotional states which are commonly associated with insomnia. In groups of 7-8, subjects will learn to perform 20 movements under the guidance of expert TCC teacher (K. Hollister, certified instructor) who will oversee treatment sessions throughout the 12 week treatment, consistent with our preliminary studies (9). Sessions will be taught over 120 minutes with 90 minutes of active TCC, 20 minutes of warm-up (e.g., stretching, breathing),10 minutes of cool down. Sessions will be mainly given in the late afternoon at 16:00 h. Thus, the TCC will be given once a week per week for a total of 120 minutes, similar in total time allocation with Cognitive Behavioral Therapy. The final week of treatment will include the development of a TCC adherence plan to ensure continuity of practice and skill maintenance during follow-up.

2: Active Comparator

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT) for insomnia will be supervised by a Ph.D. level psychologist, with specialty training in behavior therapy and behavioral medicine. The CBT sessions will be held once a week for 120 minutes (each session) over the 12-week treatment period, identical to the time schedule which was to be used for health education. Treatment will be given in small groups of 7-8 subjects. The content of the intervention will be organized around a series of modules that will be presented to patients in manualized form. For each session, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.

Detailed Description:

This investigation is a randomized controlled trial that will evaluate the effects of cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC) on objective and subjective measures of sleep, on mood and fatigue, on health functioning and on two biological parameters, sympathovagal tone and proinflammatory cytokine activity in older adults with insomnia. One hundred breast cancer survivors will be randomly assigned to CBT, or TCC. Patients will be assessed at pre-treatment, during midtreatment, post-treatment, 3-month follow-up and 12-month follow-up. At all 5 assessment periods, indices of sleep quality as measured by sleep diaries and clinical ratings will be obtained along with measures of mood, health functioning, proinflammatory cytokine activity and heart rate variability (HRV). The pre-treatment and post-treatment assessment periods will also include all-night polysomnography along with nocturnal sampling of proinflammatory cytokine activity and HRV tone. Hence, polysomnographic measures of sleep which are coupled with nocturnal measures of cytokines by serial blood sampling will occur at the baseline assessment and again at the post-treatment assessment. During midtreatment and at 3 month follow-up and 12 month follow-up, we will obtain questionnaire ratings of sleep quality along with a single morning sample of cytokine levels.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

100 postmen women between the ages of 30 - 70 years who were originally diagnosed with early, resectable breast cancer (Stage 0, I, or II, III), have completed treatment with surgery, radiation, and/or chemotherapy, and show no evidence of cancer recurrence or new primary tumor.
Difficulty sleeping for a minimum of 3 nights per week
Insomnia duration at least 6 months
Complaint of at least 1 negative effect during waking hours (e.g. fatigue, impaired functioning, mood disturbances) attributed to insomnia
Habitual sleep-wake schedule reporting "lights-out" between 9:00 PM-midnight
Accessible geographically

Exclusion Criteria:

Evidence that insomnia is directly related to a medical disorder (e.g., hyperthyroidism) or effects of a medication that affects sleep structure and/or immune functioning
Presence of sleep apnea (apnea-hypopnea index >15) or periodic limb movements during sleep (myoclonic index with arousal >15) as assessed by PSG;
Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)
Current or History of another major psychiatric disorder
Cognitive impairment as suggested by a score lower than 23 on the Mini-Mental State examination;
Smokers will also be excluded because of potential confounding effects on markers of inflammation;
Body mass index that is greater than 35 kg/m2, obesity is associated with excessive levels of inflammatory markers
Unable to commit to intervention schedule.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690196

Contacts

Contact: Michael R. Irwin, MD	(310) 825-8281	mirwin1@ucla.edu
Contact: Julie Bower, PhD	(310) 794-9383	jbower@ucla.edu

Locations

United States, California
UCLA Cousins Center for Psychoneuroimmunology	Recruiting
Los Angeles, California, United States, 91744
Contact: Michael Irwin, MD 310-825-8281 mirwin1@ucla.edu
Principal Investigator: Michael Irwin, MD
Sub-Investigator: Julie Bower, PhD
Sub-Investigator: Patricia Ganz, MD

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator:

Michael Irwin, MD

University of California, Los Angeles

More Information

The UCLA Cousins Center for Psychoneuroimmunology This link exits the ClinicalTrials.gov site

Publications:

Irwin MR, Olmstead R, Oxman MN. Augmenting immune responses to varicella zoster virus in older adults: a randomized, controlled trial of Tai Chi. J Am Geriatr Soc. 2007 Apr;55(4):511-7.

Bower JE, Ganz PA, Aziz N, Olmstead R, Irwin MR, Cole SW. Inflammatory responses to psychological stress in fatigued breast cancer survivors: relationship to glucocorticoids. Brain Behav Immun. 2007 Mar;21(3):251-8. Epub 2006 Sep 27.

Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94.

Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30.

Responsible Party:	UCLA Cousins Center for Psychoneuroimmunology ( Michael Irwin, MD, Professor in Residence )
Study ID Numbers:	R01 CA119 159, M01-RR00865
Study First Received:	March 10, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00690196
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Signs and Symptoms
Skin Diseases
Mental Disorders
Neurologic Manifestations

Dyssomnias
Sleep Disorders
Breast Neoplasms
Breast Diseases
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Site
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009