Sleep DisordersNCT00690196
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
A study testing Tai Chi Chih and Cognitive Behavioral Therapy in people with Sleep Disorders and Sleep Initiation and Maintenance Disorders, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias
- What is being tested?
- Tai Chi Chih and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, 91744
About this study
Official title: Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism
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.
Read the 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.
- Conditions
- Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias, Mental Disorders, Nervous System Diseases
- Being tested
- Tai Chi Chih, Cognitive Behavioral Therapy
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias, Mental Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ChihBehavioural
Also called TCC
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.
Cognitive Behavioral TherapyBehavioural
Also called CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tai Chi Chih Receives: Behavioral: Tai Chi Chih |
| 2 | Active comparator | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (3)
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
Measured: 5 years
Allostatic Load
Measure of metabolic and allostatic load will be assesed with clinical laboratory tests.
Measured: 5 years
Inflammatory Markers
Changes in measure of proinflammatory cytokines activity;
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMar 2008
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Michael Irwin, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690196
- Sponsor's protocol ID
- 11-000625
- Other IDs
- M01RR000865, R01 CA119 159
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2008
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17397428Bower 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.
PubMed 17008048Motivala 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.
PubMed 15784782Irwin 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.
PubMed 14508027Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism
- ClinicalTrials.gov ID
- NCT00690196
- Acronym / sponsor ID
- 11-000625
- Conditions
- Sleep Disorders, Sleep Initiation and Maintenance Disorders, Dyssomnias, Mental Disorders, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Mar 2008
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Tai Chi ChihTai Chi Chih |
| 2 | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi ChihAlso: TCCTai 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. | Behavioural | 1 |
| Cognitive Behavioral TherapyAlso: CBTCognitive 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. | Behavioural | 2 |
Primary outcome
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
3 secondary outcomes
Overall Health and Well-being
Time frame: 5 years
Allostatic Load
Time frame: 5 years
Inflammatory Markers
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 17397428Irwin 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.
- Background: PubMed 17008048Bower 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.
- Background: PubMed 15784782Motivala 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.
- Background: PubMed 14508027Irwin 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.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Irwin, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Chih and Cognitive Behavioral Therapy in people with Sleep Disorders and Sleep Initiation and Maintenance Disorders, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00690196, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.