RecruitingNot ApplicableNCT05780814

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer


Sponsor

Johns Hopkins University

Enrollment

250 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether treating insomnia can improve weight loss outcomes in breast cancer survivors who are overweight. Researchers believe poor sleep may make it harder to lose weight after cancer treatment, and they want to see if addressing insomnia first leads to better results in a behavioral weight loss program. **You may be eligible if:** - You are a woman aged 18 or older - You have been diagnosed with ductal carcinoma in situ (DCIS) or stage I–III invasive breast cancer confirmed by biopsy, within the past 10 years - You have completed surgery, radiation, and planned chemotherapy or immunotherapy - Your BMI is 25 or higher and you weigh 400 lbs or less - You are willing to work toward losing 10% of your body weight **You may NOT be eligible if:** - You have not completed your planned cancer treatments - You have stage IV (metastatic) breast cancer - You are a man - Your current health does not support participation in an exercise or weight loss program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive-Behavioral Therapy for Insomnia (CBT-I)

The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.

BEHAVIORALSleep Education Control (EDU)

Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine


Locations(4)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins

Baltimore, Maryland, United States

Johns Hopkins Bayview

Baltimore, Maryland, United States

Johns Hopkins Kimmel Cancer Center at Greenspring Station

Lutherville, Maryland, United States

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NCT05780814


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