Expired Study
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Los Angeles, California 91744


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. 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.


Study summary:

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.


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.


NCT ID:

NCT00690196


Primary Contact:

Principal Investigator
Michael Irwin, MD
University of California, Los Angeles


Backup Contact:

N/A


Location Contact:

Los Angeles, California 91744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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