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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Insomnia; Weight Gain

• Registration Number: NCT05780814
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-03-23
• Study Start: 2024-02-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Weight (pounds)	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.

Secondary Outcome Measures

Name	Time	Method
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.	Accelerometers (ActiGraph, LLC, Fort Walton Beach, FL) will be used to assess both sedentary time and moderate to vigorous physical activity.
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.	Will be measured using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, which follows an automated multiple-pass methodology.
Body composition measured through DEXA scan	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

Trial Locations

Locations (4)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Bayview; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Kimmel Cancer Center at Greenspring Station; 🇺🇸 Lutherville, Maryland, United States