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

Overview

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.

Interventions

• 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.
• Behavioral Sleep Education Control (EDU)
  Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

Primary outcome measures

• 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.]

Secondary outcome measures (3)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Sibley Memorial Hospital — Washington D.C.
• Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopk — Baltimore
• Johns Hopkins Bayview — Baltimore
• Johns Hopkins Kimmel Cancer Center at Greenspring Station — Lutherville

Identifiers

NCT: NCT05780814 · IRB00376235 · R01CA281220

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗