Breast CancerCOINNCT05780814
The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
A study testing Cognitive-Behavioral Therapy for Insomnia (CBT-I) in people with Breast Cancer and Insomnia, run by Johns Hopkins University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Insomnia, Weight Gain
- What is being tested?
- Cognitive-Behavioral Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland, 21218
Katie Smith, BA, 410-550-8099, ksmit261@jhmi.edu
Janelle Wilder Coughlin, PHD
- Recruiting
Johns Hopkins Bayview
Baltimore, Maryland, 21224
Katie Smith, BA, 410-550-8099, ksmit261@jhmi.edu
Janelle Wilder Coughlin, PHD
- Recruiting
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland, 21093
Katie Smith, BA, 410-550-8099, ksmit261@jhmi.edu
Janelle Wilder Coughlin, PHD
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Katie Smith, BA, 410-550-8099, ksmit261@jhmi.edu
Janelle Wilder Coughlin, PHD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Insomnia, Weight Gain
- Being tested
- Cognitive-Behavioral Therapy for Insomnia (CBT-I), Sleep Education Control (EDU)
- Keywords
- women, breast cancer, weight gain, weight loss, insomnia, sleep
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders, Weight Gain, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for Insomnia (CBT-I)Behavioural
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
Sleep Education Control (EDU)Behavioural
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Experimental | 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. Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
| Sleep Education Control (EDU) | Placebo comparator | 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. Receives: Behavioral: Sleep Education Control (EDU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Will be measured using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, which follows an automated multiple-pass methodology.
Measured: 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.
Accelerometers (ActiGraph, LLC, Fort Walton Beach, FL) will be used to assess both sedentary time and moderate to vigorous physical activity.
Measured: 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
Body composition will be assessed by dual energy x-ray absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass
Measured: Baseline and week 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Feb 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janelle Wilder Coughlin, PHD, Principal investigator, Johns Hopkins UniversityMichael Smith, PHD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780814
- Sponsor's protocol ID
- IRB00376235
- Other IDs
- R01CA281220
- Acronym
- COIN
- Status last verified
- Feb 2026
- First submitted
- 9 Mar 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
- ClinicalTrials.gov ID
- NCT05780814
- Acronym / sponsor ID
- COIN / IRB00376235
- Conditions
- Breast Cancer, Insomnia, Weight Gain
- Keywords
- women, breast cancer, weight gain, weight loss, insomnia, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Experimental | Behavioral: 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. |
| Sleep Education Control (EDU) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
| Sleep Education Control (EDU)Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine | Behavioural | Sleep Education Control (EDU) |
Primary outcome
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.
3 secondary outcomes
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.
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.
Body composition measured through DEXA scan
Time frame: Baseline and week 61
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janelle Wilder Coughlin, PHD principal investigator
Johns Hopkins University
Michael Smith, PHD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy for Insomnia (CBT-I) in people with Breast Cancer and Insomnia, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janelle Wilder Coughlin, PHD ((410) 550-7000, jwilder3@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.