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

Workflow State: 
Approved
Type of proposal: 
Participant recruitment (what is this?)
Does this project have funding?: 
Yes

Researcher Information

First name: 
Michael
Last name: 
Irwin
Degree: 
MD
Work phone number: 
(310) 825-8081

Institution Information

University of California, Los Angeles
300 Medical Plaza, Suite 3109
90095 Los Angeles , CA
United States

Project Information

List of Collaborators: 
Julienne Bower, PhD; Patricia Ganz, MD
Number of Participants Needed: 
55
Inclusion and Exclusion Criteria: 
Inclusion criteria This study will include a) 100 postmenopausal women between the ages of 30 – 85 years who were originally diagnosed with early, resectable breast cancer (Stage 0, I, II), have completed treatment with surgery, radiation, and/or chemotherapy, and show no evidence of cancer recurrence or new primary tumor. We will focus on middle- to older aged breast cancer survivors, given evidence that the prevalence of insomnia in the breast cancer population increases with age. We will focus on women who are at least 1 year post-treatment completion to reduce confounding residual effects of cancer treatment on immune parameters (85) and because of our interest in chronic insomnia. We plan to include women treated with radiation and/or chemotherapy, as similar rates and severity of sleep problems have been noted among women treated with each of these modalities. The additional inclusion criteria for insomnia are: (b) Sleep-onset or maintenance insomnia, defined as sleep onset latency and/or wake after sleep onset longer than 30 minutes per night with a corresponding sleep efficiency (ratio of total sleep time to time spent in bed) lower than 85%; (c) Difficulties with sleep for a minimum of 3 nights per week; (d) Insomnia duration of at least 6 months; (e) Complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) attributed to insomnia; (f) Habitual sleep-wake schedule reporting “lights-out” between 21:00 and 24:00 h; (g) Accessible geographically. As noted in the Introduction, item 2 of Critique 3, PSG will be used to screen for and exclude other sleep disorders (see below), but will not be used as an eligibility criterion or for study entry. Exclusion criteria: (a) 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 (b) Presence of sleep apnea (apnea-hypopnea index >15) or periodic limb movements during sleep (myoclonic index with arousal >15) as assessed by PSG; (c) Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome); (d) Regular use of a psychotropic medication and/or current psychotherapy or other behavioral therapy that would confound TCC; (f) Presence of current psychiatric disorder (e.g. current major depression, alcohol or substance dependence, anxiety disorder) as identified by the SCID for DSM-IV-TR (subjects must be free of a major psychiatric illness for 6 months prior to study) (84, 87); (g) Cognitive impairment as suggested by a score lower than 23 on the Mini-Mental State examination(88); (h) Smokers will also be excluded because of potential confounding effects on markers of inflammation; (i) Body mass index that is greater than 35 kg/m2, obesity (89) is associated with excessive levels of inflammatory marker; (j) lymphedema as nocturnal swelling could lead to pain and disordered sleep; (k) Unable to commit to intervention schedule.

Project Details

Primary Area of Study: 
IRB Approval: 
Yes
Legacy Date Received: 
2009-11-13 12:11:47