~1 spots leftby Jul 2025

Tai Chi for Insomnia in Breast Cancer Survivors

MI
Overseen byMichael Irwin, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo Group

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.

Research Team

MI

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.
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

Treatment Details

Interventions

  • Cognitive Behavioral Therapy (Behavioral Intervention)
  • Tai Chi Chih (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Tai Chi Chih
Group II: 2Active Control1 Intervention
Cognitive Behavioral Therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+
Dr. Aparna Bhaduri profile image

Dr. Aparna Bhaduri

Jonsson Comprehensive Cancer Center

Chief Medical Officer since 2024

MD

Dr. Michael A. Teitell profile image

Dr. Michael A. Teitell

Jonsson Comprehensive Cancer Center

Chief Executive Officer since 2024

MD, PhD

National Center for Research Resources (NCRR)

Collaborator

Trials
540
Recruited
317,000+

Barbara M. Alving

National Center for Research Resources (NCRR)

Chief Executive Officer since 2005

MD from Georgetown University School of Medicine

Lawrence A. Tabak profile image

Lawrence A. Tabak

National Center for Research Resources (NCRR)

Chief Medical Officer since 2009

MD from University of Pennsylvania