The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer (NCT05780814)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Sibley Memorial Hospital — Washington D.C., District of Columbia
Age range: 18 Years
🧪 Interventions in This Study
- Cognitive-Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL)
- Sleep Education Control (EDU) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins — Baltimore, Maryland
- Johns Hopkins Bayview — Baltimore, Maryland
- Johns Hopkins Kimmel Cancer Center at Greenspring Station — Lutherville, Maryland
📞 Contact the Study Coordinator
Phone: (410) 550-7000
Email: jwilder3@jhmi.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.