Tai Chi for Insomnia in Breast Cancer Survivors

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Sleep apnea, Psychiatric disorder, Cognitive impairment, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8-12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your insomnia is directly related to a medication that affects sleep or immune function, you may not be eligible to participate.

What data supports the effectiveness of this treatment for insomnia in breast cancer survivors?

Research shows that Tai Chi Chih, a form of movement meditation, is as effective as cognitive behavioral therapy for improving insomnia symptoms in breast cancer survivors. Additionally, Tai Chi has been found to improve sleep quality and reduce fatigue in cancer survivors, making it a promising treatment option. ^{1 2 3 4 5}

Is Tai Chi safe for breast cancer survivors with insomnia?

Tai Chi is generally considered safe for breast cancer survivors, as it is a light-to-moderate intensity exercise that can improve sleep quality and reduce fatigue without the need for equipment. It has been studied in various trials and is seen as a feasible alternative to more intense exercise programs. ^{1 2 3 4 5}

How does Tai Chi Chih differ from other treatments for insomnia in breast cancer survivors?

Tai Chi Chih is a movement meditation that is unique because it not only improves insomnia symptoms but also reduces inflammation, which is not typically addressed by other treatments like cognitive behavioral therapy for insomnia (CBT-I). This makes it a holistic approach that may offer additional health benefits beyond just improving sleep. ^{1 2 3 4 6}

Research Team

Michael Irwin, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for postmenopausal women aged 30-70 who had early-stage breast cancer, have finished treatment, and are now struggling with chronic insomnia. They should experience sleep difficulties at least three nights a week for over six months and live close enough to attend sessions. Exclusions include those with certain medical conditions affecting sleep or immune function, obesity (BMI >35), smokers, cognitive impairment, other major psychiatric disorders or different sleep disorders.

Inclusion Criteria

I am a postmenopausal woman, aged 30-70, with treated early-stage breast cancer and no signs of cancer returning.

I have had trouble sleeping for at least 6 months.

I experience negative effects like fatigue due to insomnia.

Exclusion Criteria

I have another sleep disorder, like sleeping too early or too late.

People who smoke will not be included because it could affect the study results.

My insomnia is caused by another health issue or medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Assessment

Baseline assessment including all-night polysomnography and nocturnal sampling of proinflammatory cytokine activity and HRV tone

1 week

1 visit (in-person)

Treatment

Participants receive either Tai Chi Chih or Cognitive Behavioral Therapy

8-12 weeks

Weekly sessions

Mid-treatment Assessment

Midtreatment assessment with questionnaire ratings of sleep quality and a single morning sample of cytokine levels

1 week

1 visit (in-person)

Post-treatment Assessment

Post-treatment assessment including all-night polysomnography and nocturnal sampling of proinflammatory cytokine activity and HRV tone

1 week

1 visit (in-person)

3-month Follow-up

Assessment of sleep quality, mood, health functioning, and cytokine levels

1 week

1 visit (in-person)

12-month Follow-up

Assessment of sleep quality, mood, health functioning, and cytokine levels

1 week

1 visit (in-person)

Treatment Details

Interventions

• Cognitive Behavioral Therapy
• Tai Chi Chih

Trial Overview The study is testing the effectiveness of Tai Chi Chih (TCC), a meditative movement practice, against Cognitive Behavioral Therapy in improving sleep quality among breast cancer survivors with chronic insomnia. It aims to see if TCC can reduce fatigue and inflammation related to poor sleep.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

Tai Chi Chih

Group II: 2 Active Control 1 Intervention

Cognitive Behavioral Therapy

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

Findings from Research

In a pilot study involving 21 breast cancer survivors, individual cognitive behavioral therapy for insomnia (IND-CBT-I) significantly improved self-rated insomnia and sleep quality compared to a delayed treatment control group.

The results suggest that IND-CBT-I is a practical and effective option for improving sleep in breast cancer survivors, making it accessible in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Fiorentino, L., McQuaid, JR., Liu, L., et al.[2021]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

The effect of an evidence-based Tai chi intervention on the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients: A preliminary randomised controlled trial. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Development and validation of a Tai chi intervention protocol for managing the fatigue-sleep disturbance-depression symptom cluster in female breast cancer patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Tai chi, cellular inflammation, and transcriptome dynamics in breast cancer survivors with insomnia: a randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Tai Chi for cancer survivors: A systematic review toward consensus-based guidelines. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. [2021]