Status:
ACTIVE_NOT_RECRUITING
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Sleep Disorders
Sleep Initiation and Maintenance Disorders
Eligibility:
FEMALE
30-70 years
Phase:
NA
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...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00690196
Start Date
March 1 2008
End Date
July 31 2027
Last Update
November 10 2025
Active Locations (1)
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1
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, United States, 91744