NCT05780814 The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
| NCT ID | NCT05780814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-02-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Janelle Wilder Coughlin, PHD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05780814 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05780814 currently recruiting?
Yes, NCT05780814 is actively recruiting participants. Contact the research team at jwilder3@jhmi.edu for enrollment information.
Where is the NCT05780814 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States, Baltimore, United States, Lutherville, United States.
Who is sponsoring the NCT05780814 clinical trial?
NCT05780814 is sponsored by Johns Hopkins University. The principal investigator is Janelle Wilder Coughlin, PHD at Johns Hopkins University. The trial plans to enroll 250 participants.
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