Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

NCT00690196 | Active Not Recruiting DMC

• 3 other identifiers: 11-000625M01RR000865R01 CA119 159
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators 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.

Conditions

Sleep Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Mental Disorders; Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (3)

• Overall Health and Well-being

  5 years

• Allostatic Load

  5 years

• Inflammatory Markers

  5 years

Study Arms (2)

1

EXPERIMENTAL

Tai Chi Chih

Behavioral: Tai Chi Chih

2

ACTIVE COMPARATOR

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Tai Chi Chih BEHAVIORAL

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.

Also known as: TCC

1

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

UCLA Cousins Center for Psychoneuroimmunology

Los Angeles, California, 91744, United States

Location

Related Publications (5)

• 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. doi: 10.1111/j.1532-5415.2007.01109.x.

  PMID: 17397428 BACKGROUND

• 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. doi: 10.1016/j.bbi.2006.08.001. Epub 2006 Sep 27.

  PMID: 17008048 BACKGROUND

• 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. doi: 10.1097/01.psy.0000149259.72488.09.

  PMID: 15784782 BACKGROUND

• 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. doi: 10.1097/01.psy.0000088591.86103.8f.

  PMID: 14508027 BACKGROUND

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Mental Disorders; Nervous System Diseases

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Irwin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: June 4, 2008
• Study Start: March 1, 2008
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)