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Title:
Cancer, Obesity/Overweight and Insomnia (COIN) Study
Protocol Number:
J17120
Phase:
Pilot
Physician:
Janelle Coughlin
Sites:
Johns Hopkins Bayview Medical Center
Purpose:
This research is being done to assess the effectiveness of a web- and phone-based sleep and weight loss intervention in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range ( greater than 25). 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 obese individuals with cancer and has been shown to promote unhealthy eating, reduced physical activity and to predict breast cancer risk. Our goal is to better understand the relationship between insomnia and weight loss in women with breast cancer.
Eligibility:
- 18 years of age or older- Current BMI equal to 25 and weight equal to 400 lbs - DCIS or stage 0-III breast cancer- Completed all surgery and local therapy greater than 3 months ago- Hormonal agents are allowed, such as tamoxifen or an aromatase inhibitor- Reports trouble sleeping or is diagnosed with insomnia- Willing to lose 10% of body weight- Daily access to internet and/or smartphone- Not currently enrolled in a sleep or weight loss program- Not currently taking weight loss medications or sleeping aids
Treatment:
Eligible participants will be randomized to 1 of 2 arms for the sleep intervention: sleep education (EDU) or cognitive behavioral therapy for insomnia (CBT-I). Both arms will undergo the same behavioral weight loss (BWL) intervention following the sleep program. Overall, the study will involve 6 in-person visits and approximately 18 phone/video sessions over an 8-month period.
Population:
Adult
Last Update
03/05/2019 05:03 AM