Actively Recruiting
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Led by Johns Hopkins University · Updated on 2026-02-23
250
Participants Needed
4
Research Sites
256 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- 18 years of age or older
- Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasive carcinoma of the breast
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Current BMI 25 kg/m2 and weight 24 400 lbs
- Willing to lose 10% of body weight
- Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast
- Completed local therapy (surgery and radiation) and any planned chemotherapy/immunotherapy at least 3 months before enrollment
- Completed all planned/elective surgeries more than 4 weeks before enrollment
- Meet DSM-5 criteria for insomnia disorder
- Self-reported sleep onset or wake after sleep onset greater than 30 minutes, more than 3 nights per week
- Sleep problems lasting 3 months or more
- Insomnia Severity Index score of 9 or higher
You will not qualify if you...
- Serious or uncontrolled medical or psychiatric conditions that hinder participation (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)
- Current use of medications causing sleep disturbances or affecting weight
- Current use of sedative hypnotics
- Sleep disorders other than insomnia (except mild or treated moderate to severe sleep apnea)
- Enrollment in or planning to enroll in other sleep or weight loss programs during the study
- History of unstable psychiatric disorders
- Suicidal ideation or severe depression (CES-D score 20)
- Lactating, pregnant, or planning pregnancy in next 14 months
- Positive urine drug test for recreational drugs
- Alcohol or substance use disorder
- Daily smoker or nicotine user
- Any condition the investigator believes increases risk or prevents full study compliance
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Trial Site Locations
Total: 4 locations
1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland, United States, 21218
Actively Recruiting
3
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
Actively Recruiting
4
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland, United States, 21093
Actively Recruiting
Research Team
J
Janelle Wilder Coughlin, PHD
CONTACT
K
Katie Smith, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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