The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ 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 ≤ 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 (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy/immunotherapy(/HER2) human epidermal growth factor receptor 2 therapy/targeted therapy at least 3months prior to enrollment (concomitant endocrine therapy allowed)
You may not qualify if…
- ✕ Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)
- ✕ Current use of medications that cause sleep disturbances or weight gain/loss. (-) Current sedative hypnotic use
- ✕ Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted
- ✕ Currently enrolled or planning to enroll in a sleep treatment or weight loss program (agree not to enroll for the duration of the study) (-) Home sleep test Apnea/hypopnea Index (AHI) \> 15
- ✕ Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).
- ✕ History of unstable psychiatric disorder
- ✕ Self-reported suicidal ideation or severe depressive symptoms as determined by clinical assessment, triggered by score of ≥ 20 on the Center for Epidemiologic Studies Depression (CES-D)
- ✕ Lactating, pregnant or plan to become pregnant in next 14 months
Where it's recruiting
Washington D.C.
Baltimore · Lutherville
Source: ClinicalTrials.gov · NCT05780814 · last updated 2026-02-23