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

February 19, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The entire study will span a 14-month period and involves one video screening visit (V1) and 4 in-person assessment visits (V2-V5) and 27 video sessions (6 for sleep intervention or sleep control and 19 for BWL). After passing an initial phone screen, participants will be scheduled for in-depth screening (V1). The investigators will complete urine samples for pregnancy and substances, administer study measures, obtain weight, height, anthropometrics and randomize at in-person visit (V2). The overall framework of the BWL intervention is social cognitive theory (increasing self-efficacy and social support) with motivational interviewing (MI) as an approach to helping participants engage in established behavior change strategies (e.g. self-monitoring, stimulus control, goal setting, feedback, etc.) aimed at reducing dietary intake and increasing physical activity (PA). Body composition will be assessed by Dual Energy X-Ray Absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass. The investigators will conduct DEXA scans at two time points (V1 & V5).The investigators' primary endpoint is % total weight loss (TWL) at 12 months. The investigators will measure weight in light clothes without shoes, using a digital scale and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Janelle Wilder Coughlin, PHD
  • Phone Number: (410) 550-7000
  • Email: jwilder3@jhmi.edu

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Janelle Wilder Coughlin, PHD
        • Principal Investigator:
          • Michael Smith, PHD
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Bayview
        • Contact:
        • Principal Investigator:
          • Janelle Wilder Coughlin, PHD
        • Principal Investigator:
          • Michael Smith, PHD
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
        • Contact:
        • Principal Investigator:
          • Janelle Wilder Coughlin, PHD
        • Principal Investigator:
          • Michael Smith, PHD
      • Lutherville, Maryland, United States, 21093
        • Recruiting
        • Johns Hopkins Kimmel Cancer Center at Greenspring Station
        • Contact:
        • Principal Investigator:
          • Janelle Wilder Coughlin, PHD
        • Principal Investigator:
          • Michael Smith, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
The 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.
Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
Placebo Comparator: Sleep Education Control (EDU)
The 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.
Behavioral: Sleep Education Control (EDU)
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight (pounds)
Time Frame: Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Time Frame: Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Will be measured using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, which follows an automated multiple-pass methodology.
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.
Time Frame: Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.
Accelerometers (ActiGraph, LLC, Fort Walton Beach, FL) will be used to assess both sedentary time and moderate to vigorous physical activity.
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
Time Frame: Baseline and week 61
Body composition will be assessed by dual energy x-ray absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass
Baseline and week 61

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janelle Wilder Coughlin, PHD, Johns Hopkins University
  • Principal Investigator: Michael Smith, PHD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00376235
  • R01CA281220 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings