The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
COIN
2 other identifiers
interventional
250
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Feb 2024
Typical duration for not_applicable breast-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 23, 2026
February 1, 2026
4.9 years
March 9, 2023
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Weight (pounds)
Our primary endpoint is % total weight loss (TWL) at 12 months. We will measure weight in light clothes without shoes, using a digital scale (in pounds) and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.
Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Secondary Outcomes (3)
Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Physical activity assessed by wearing and accelerometer to track movement.
Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Body composition measured through DEXA scan
Baseline and week 61
Study Arms (2)
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
EXPERIMENTALThe proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be \~60 mins, and remaining visits are \~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.
Sleep Education Control (EDU)
PLACEBO COMPARATORThe EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.
Interventions
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine
Eligibility Criteria
You may qualify if:
- Female
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Johns Hopkins Universitylead
Study Sites (4)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland, 21218, United States
Johns Hopkins Bayview
Baltimore, Maryland, 21224, United States
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland, 21093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janelle Wilder Coughlin, PHD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Michael Smith, PHD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2023
First Posted
March 23, 2023
Study Start
February 1, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02