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

Primary Purpose

Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi Chih
Cognitive Behavioral Therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Cousins Center for Psychoneuroimmunology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Tai Chi Chih

Cognitive Behavioral Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Health and Well-being
Changes in sympathovagal function and energy balance; Changes in measures of interpersonal resilience and social functioning; physical activity; cognitive function; mental health
Allostatic Load
Measure of metabolic and allostatic load will be assesed with clinical laboratory tests.
Inflammatory Markers
Changes in measure of proinflammatory cytokines activity;

Full Information

First Posted
March 10, 2008
Last Updated
September 14, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00690196
Brief Title
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Official Title
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias, Mental Disorders, Nervous System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tai Chi Chih
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Chih
Other Intervention Name(s)
TCC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Health and Well-being
Description
Changes in sympathovagal function and energy balance; Changes in measures of interpersonal resilience and social functioning; physical activity; cognitive function; mental health
Time Frame
5 years
Title
Allostatic Load
Description
Measure of metabolic and allostatic load will be assesed with clinical laboratory tests.
Time Frame
5 years
Title
Inflammatory Markers
Description
Changes in measure of proinflammatory cytokines activity;
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Irwin, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Cousins Center for Psychoneuroimmunology
City
Los Angeles
State/Province
California
ZIP/Postal Code
91744
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17397428
Citation
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.
Results Reference
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PubMed Identifier
17008048
Citation
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.
Results Reference
background
PubMed Identifier
15784782
Citation
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.
Results Reference
background
PubMed Identifier
14508027
Citation
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.
Results Reference
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Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

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