Treating insomnia to improve weight loss in breast cancer survivors
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
This study is testing whether a sleep therapy can help overweight or obese breast cancer survivors lose weight more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Washington D.C., District of Columbia and 3 other locations) |
| Trial ID | NCT05780814 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a history of early-stage breast cancer, who are overweight or obese and meet the criteria for insomnia disorder.
Not a fit: Patients who are not female, do not have a history of breast cancer, or do not meet the criteria for insomnia disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved weight loss outcomes and overall health for breast cancer survivors suffering from insomnia.
How similar studies have performed: Other studies have shown promising results with cognitive-behavioral interventions for insomnia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.