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

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Insomnia, Weight Gain

In brief

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.

Key facts

Study ID

NCT05780814

Run by

Johns Hopkins University

People needed

250

Starts

2024-02-01

Expected to finish

2028-12-31

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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)
• 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

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
• 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 is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.