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Completed NCT00690196

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

Conditions: Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias, Mental Disorders, Nervous System Diseases

Sex: Female
Ages: 30 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Jonsson Comprehensive Cancer Center

Location: UCLA Cousins Center for Psychoneuroimmunology Los Angeles California

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.

Eligibility 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.

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Source: ClinicalTrials.gov (NCT00690196). StuddyBuddy aggregates publicly available trial information.