This clinical trial compares the effect of cognitive behavioral therapy for insomnia (CBT-I) plus behavioral weight loss (BWL) intervention to sleep education (EDU) plus BWL intervention on weight loss and body composition in overweight or obese women with breast ductal carcinoma in situ (DCIS) or stage I-III invasive breast cancer and sleep problems (insomnia). Obesity and insomnia are two of the most common disorders in breast cancer and are linked with increased risk of breast cancer and poor outcomes. In fact, approximately 96% of women gain a significant amount of weight after a breast cancer diagnosis. Weight loss is beneficial in improving cardiovascular risk factors and overall health, but may also decrease the chance of breast cancer recurrence. Insomnia, a highly treatable sleep disorder, is especially common in individuals with cancer and overweight and can increase unhealthy eating and reduce physical activity. CBT-I is a structured program that helps the patient identify and replace thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. EDU may be an effective method to help people learn about sleep and sleep disorders, which may help improve sleep. Behavioral interventions, such as BWL, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. CBT-I plus BWL may be more effective than EDU plus BWL in improving sleep, weight loss and body composition in overweight or obese women with breast DCIS or stage I-III invasive breast cancer and insomnia.
Additional locations may be listed on ClinicalTrials.gov for NCT05780814.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins Bayview Medical CenterStatus: Active
Contact: Janelle Kate Coughlin
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Contact: Janelle Kate Coughlin
Phone: 410-550-7988
PRIMARY OBJECTIVES:
I. Evaluate the short (3 month [mo]), intermediate (6 mo), and long-term (12-mo) effects of CBT-I+BWL compared to EDU+BWL on weight loss (% total weight loss [TWL] 12-months, primary) and body composition (secondary).
II. Evaluate the extent to which 12-month weight loss is mediated by pre to post sleep treatment changes in sleep parameters (sleep efficiency, SE; and total sleep time, TST).
EXPLORATORY OBJECTIVE:
I. Determine whether CBT-I+BWL alters caloric intake, diet quality and/or physical activity relative to EDU+BWL and evaluate the extent to which these factors are associated with sleep continuity and weight loss at 3, 6 and 12-months.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (CBT-I + BWL): Patients attend individualized CBT-I instruction sessions focusing on changing sleep patterns, activities, and habits over 45-90 minutes each weekly in weeks 1, 2, 4, 6, 7, and 8. 1-2 weeks after completion of the sleep program, patients undergo BWL videoconferencing sessions over 30 minutes weekly for 12 weeks, then monthly during months 4-12. Patients receive CBT-I sleep maintenance sessions over 15-30 minutes during months 4 and 9 of BWL. Patients also wear a sleep testing device during screening and an actiwatch continuously for 7 days prior to randomization, week 8, and months 3, 6 and 12. Additionally, patients undergo dual x-ray absorptiometry (DEXA) and collection of urine samples throughout the study.
ARM II (EDU + BWL): Patients receive sleep education sessions focusing on increasing knowledge about sleep and sleep disorders over 45-90 minutes each weekly in weeks 1, 2, 4, 6, 7, and 8. 1-2 weeks after completion of the sleep program, patients undergo BWL videoconferencing sessions over 30 minutes weekly for 12 weeks, then monthly during months 4-12. Patients receive sleep education maintenance sessions to review earlier content over 15-30 minutes during months 4 and 9 of BWL. Patients also wear a sleep testing device during screening and an actiwatch continuously for 7 days prior to randomization, week 8, and months 3, 6 and 12. Additionally, patients undergo DEXA and collection of urine samples throughout the study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorJanelle Kate Coughlin
