Tai Chi for Insomnia in Breast Cancer Survivors

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help breast cancer survivors struggling with chronic insomnia by testing the effectiveness of Tai Chi Chih, a type of slow-moving meditation, in improving sleep quality. Participants will be compared with those receiving Cognitive Behavioral Therapy, a known treatment for insomnia. Women who have been cancer-free after early breast cancer treatment and experience sleep troubles at least three times a week for over six months might be a good fit.

As an unphased trial, this study provides a unique opportunity to explore alternative therapies for enhancing sleep quality.

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 prior data suggests that Tai Chi Chih is safe for breast cancer survivors with insomnia?

Research has shown that Tai Chi Chih is generally safe for breast cancer survivors. This gentle exercise can help improve sleep. Studies have found that Tai Chi Chih not only aids sleep but also reduces fatigue, making it a promising option for those struggling with sleep problems after cancer treatment. Reports of harmful side effects are rare, suggesting it is well-tolerated. Overall, Tai Chi Chih appears to be a safe and effective way to manage sleep issues in breast cancer survivors.12345

Why are researchers excited about this trial?

Tai Chi Chih is unique because it offers a holistic approach to managing insomnia in breast cancer survivors, focusing on gentle, mindful movements that promote relaxation and improve sleep quality. Unlike standard treatments like medication or cognitive behavioral therapy, Tai Chi Chih emphasizes physical and mental harmony, potentially reducing stress and enhancing overall well-being without the side effects often associated with pharmaceutical options. Researchers are excited about this method because it combines physical activity with meditation, offering a non-invasive, side-effect-free alternative to traditional insomnia treatments.

What evidence suggests that this trial's treatments could be effective for insomnia in breast cancer survivors?

Research has shown that Tai Chi Chih (TCC), which participants in this trial may receive, can help breast cancer survivors with sleep difficulties. Studies have found that TCC significantly improves sleep quality and duration. In one study, nearly half of the women who practiced Tai Chi or participated in cognitive behavioral therapy (CBT), another treatment option in this trial, experienced much better sleep after a year. Tai Chi also reduces inflammation, often linked to sleep problems in breast cancer survivors. Although more research is needed, early results suggest that Tai Chi Chih could effectively improve sleep for these individuals.12678

Who Is on the Research Team?

MI

Michael Irwin, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.
You usually go to bed between 9:00 PM and midnight.
See 3 more

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.
See 5 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Group II: 2Active Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

Tai Chi Chih Compared With Cognitive Behavioral Therapy ...It is not known whether TCC is an effective treatment of insomnia in survivors of breast cancer, even though up to 50% of survivors of breast cancer report ...
Tai Chi compared with cognitive behavioral therapy and ...Tai Chi, as compared to cognitive behavioral therapy for insomnia, preferentially reduces inflammation in breast cancer survivors. Abstract. Background.
Tai Chi for cancer survivors: A systematic review toward ...Tai Chi training may improve fatigue and sleep quality in cancer survivors. Future research should examine a broader range of outcomes, ...
Tai Chi Helps Ease Insomnia in Breast Cancer SurvivorsA year after either tai chi or cognitive behavioral therapy ended, nearly half the women in each treatment group had substantial improvement in ...
Tai Chi Chih Compared With Cognitive Behavioral Therapy ...Primary outcome was insomnia treatment response—that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index—at 15 months. Secondary ...
Feasibility and potential effects of tai chi for the fatigue ...Tai chi has been supported as a promising non-pharmacological intervention for the individual symptom relief of cancer-related fatigue, sleep disturbance and ...
Tai Chi for Insomnia in Breast Cancer SurvivorsTai 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 ...
Tai Chi for cancer survivors: A systematic review toward ...Tai Chi training may improve fatigue and sleep quality in cancer survivors. Future research should examine a broader range of outcomes, ...
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