The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Johns Hopkins University
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.
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 soci…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 recepto…
Interventions
- BehavioralCognitive-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.
- BehavioralSleep Education Control (EDU)
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine
Locations (4)
- Sibley Memorial HospitalWashington D.C., District of Columbia
- Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns HopkinsBaltimore, Maryland
- Johns Hopkins BayviewBaltimore, Maryland
- Johns Hopkins Kimmel Cancer Center at Greenspring StationLutherville, Maryland