Treating insomnia to improve weight loss in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of a cognitive-behavioral intervention for insomnia (CBT-I) on weight loss outcomes in women who are breast cancer survivors and are overweight or obese. Participants will be randomly assigned to either the CBT-I intervention or a sleep education control, followed by a behavioral weight loss program. The study will measure various outcomes, including total weight loss, over a 12-month period through multiple assessments and interventions. The approach combines social cognitive theory and motivational interviewing to enhance participants' self-efficacy and support for behavior change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)
* Completed all planned/elective surgeries \>4 weeks before enrollment
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder
* Self-reported initial sleep onset time and/or wake after sleep onset (WASO) time \> 30 minutes, \> 3 nights/week
* Reports sleep problems present for ≥ 3 months
* Insomnia Severity Index Score ≥ 9

Exclusion Criteria:

* 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
* Positive urine toxicology for recreational drugs of abuse; alcohol or substance use disorder as determined by Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT294) and/or Structured Clinical Interview (SCID)
* Daily smoker/nicotine user
* Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the patient's full compliance with or completion of the study

Where it's running

• Sibley Memorial Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Johns Hopkins Bayview
  Baltimore, Maryland, United States Recruiting
• Johns Hopkins Kimmel Cancer Center at Greenspring Station
  Lutherville, Maryland, United States Recruiting

Study contacts

• Principal investigator: Janelle Wilder Coughlin, PHD — Johns Hopkins University
• Study coordinator: Janelle Wilder Coughlin, PHD
• Email: jwilder3@jhmi.edu
• Phone: (410) 550-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.