The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 1 visit
- Procedures mentioned: Urine samples, X-rays
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- "The investigators will complete urine samples for pregnancy and substances, administer study measures, obtain weight, height, anthropometrics and randomize at in-person visit (V2)."
- "Body composition will be assessed by Dual Energy X-Ray Absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether brief therapy for insomnia before a weight loss program works better than sleep education before the same program. Insomnia means trouble falling or staying asleep. The study is for women with a history of early-stage breast cancer who are overweight or obese and have insomnia.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older.
- Diagnosed within the past 10 years with DCIS (cancer inside breast milk ducts) or stage I–III breast cancer, confirmed by a tissue test.
- Able to care for yourself and be out of bed or a chair for more than half of your waking hours (ECOG score 0–2).
- Have a BMI of at least 25, a measure of weight compared with height; weigh 400 pounds or less.
- Willing to lose 10% of your body weight.
- Finished surgery, radiation, and any planned chemotherapy, immune therapy, or targeted cancer drugs at least 3 months ago. Hormone therapy is allowed.
- Finished all planned or elective surgeries more than 4 weeks ago.
- Have diagnosed insomnia for at least 3 months and an Insomnia Severity Index score of at least 9. Take more than 30 minutes to fall asleep or spend more than 30 minutes awake during the night, more than 3 nights a week.
Who can't join
- Have a serious or uncontrolled medical or mental health condition that could limit participation, or a history of an unstable mental health condition.
- Take medicines that disturb sleep or cause weight gain or loss, or currently use sedative sleep medicines.
- Have a sleep disorder other than insomnia. Mild sleep apnea or moderate to severe sleep apnea successfully treated with a breathing device is allowed; a home sleep test score (AHI) above 15 is listed as a reason you cannot join.
- Are in or plan to join another sleep treatment or weight loss program, or will not agree to avoid these programs during the study.
- Report thoughts of suicide or have severe depression symptoms found during a clinical assessment.
- Are breastfeeding, pregnant, or planning to become pregnant in the next 14 months.
- Test positive for recreational drugs, have an alcohol or substance use disorder, or use tobacco or nicotine daily.
- Have any other issue that the study doctor believes would raise your risk or keep you from following or finishing the study.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (4)
DC
- Sibley Memorial Hospital · Washington D.C., DC 20016Katie Smith, BA · Study contact · 410-550-8099 · ksmit261@jhmi.eduJanelle Wilder Coughlin, PHD · Principal investigatorMichael Smith, PHD · Principal investigatorMore trials in Washington D.C.
MD
- Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins · Baltimore, MD 21218Katie Smith, BA · Study contact · 410-550-8099 · ksmit261@jhmi.eduJanelle Wilder Coughlin, PHD · Principal investigatorMichael Smith, PHD · Principal investigatorMore trials in Baltimore
- Johns Hopkins Bayview · Baltimore, MD 21224Katie Smith, BA · Study contact · 410-550-8099 · ksmit261@jhmi.eduJanelle Wilder Coughlin, PHD · Principal investigatorMichael Smith, PHD · Principal investigatorMore trials in Baltimore
- Johns Hopkins Kimmel Cancer Center at Greenspring Station · Lutherville, MD 21093Katie Smith, BA · Study contact · 410-550-8099 · ksmit261@jhmi.eduJanelle Wilder Coughlin, PHD · Principal investigatorMichael Smith, PHD · Principal investigatorMore trials in Lutherville