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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Allostatic Load
Inflammatory Markers
Overall Health and Well-being
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
359 Previous Clinical Trials
25,985 Total Patients Enrolled
National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,926 Total Patients Enrolled
Michael Irwin, MDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
102 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another sleep disorder, like sleeping too early or too late.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.People who smoke will not be included because it could affect the study results.I experience negative effects like fatigue due to insomnia.You usually go to bed between 9:00 PM and midnight.My insomnia is caused by another health issue or medication.You have a body mass index (BMI) higher than 35, which indicates obesity and can lead to high levels of inflammation in the body.I cannot commit to the treatment schedule.You currently have or have had another serious mental health condition.You have been diagnosed with sleep apnea or periodic limb movements during sleep.I have trouble sleeping at least 3 nights a week.You have trouble with thinking and remembering things, as shown by a test score lower than 23 on the Mini-Mental State examination.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants over 30 years of age eligible for enrollment in this research study?
"To join this experimental treatment trial, participants must be aged 30 - 70 years. In contrast, there are 380 trials for minors and 1112 studies available to seniors."
Answered by AI
Who are the ideal participants for this research endeavor?
"This clinical trial is accepting applications from individuals diagnosed with mental illness, between the ages of 30 and 70. 90 participants will be accepted into this study in total."
Answered by AI
Are investigators actively recruiting participants for this research?
"Based on the information available through clinicaltrials.gov, this medical study is no longer seeking candidates. It was initially posted in March 2008 and last amended in March 2023; however, there are 1,617 other trials that presently require participants at this time."
Answered by AI
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