The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Start Date
2/1/2024
Completion Date
12/31/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Sleep Education Control (EDU)
Conditions
Locations
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
United States
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland 21218
United States
Johns Hopkins Bayview
Baltimore, Maryland 21224
United States
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland 21093
United States