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Tai Chi for Insomnia in Breast Cancer Survivors

N/A
Waitlist Available
Led By Michael Irwin, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
100 postmenopausal 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
Insomnia duration of at least 6 months
Must not have
Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)
Unable to commit to intervention schedule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine the efficacy of TTC on sleep impairments in women with breast cancer. #BreastCancer is common in women; TTC may improve sleep, fatigue & inflammation, & help long-term survival.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated for this trial, Tai Chi Chih is generally considered low-risk but may cause muscle soreness or strain. Cognitive Behavioral Therapy typically has no physical side effects but can sometimes cause temporary increases in distress as individuals confront their thoughts and behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a postmenopausal woman, aged 30-70, with treated early-stage breast cancer and no signs of cancer returning.
Select...
I have had trouble sleeping for at least 6 months.
Select...
I have trouble sleeping at least 3 nights a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have another sleep disorder, like sleeping too early or too late.
Select...
I cannot commit to the treatment schedule.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Allostatic Load
Inflammatory Markers
Overall Health and Well-being

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Tai Chi Chih
Group II: 2Active Control1 Intervention
Cognitive Behavioral Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tai Chi Chih
2004
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,104 Total Patients Enrolled
National Center for Research Resources (NCRR)NIH
539 Previous Clinical Trials
317,012 Total Patients Enrolled
Michael Irwin, MDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
102 Total Patients Enrolled

Media Library

Tai Chi Chih Clinical Trial Eligibility Overview. Trial Name: NCT00690196 — N/A
Permanent Neurological Damage Research Study Groups: 1, 2
Permanent Neurological Damage Clinical Trial 2023: Tai Chi Chih Highlights & Side Effects. Trial Name: NCT00690196 — N/A
Tai Chi Chih 2023 Treatment Timeline for Medical Study. Trial Name: NCT00690196 — N/A
~3 spots leftby Jul 2025
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