Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship (NCT06807086)
🩺 Plain-English Summary (8th-Grade Level)
This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications. Notably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1). This project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation. Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.
Who can join: Review the eligibility criteria below.
Location: Massachusetts General Hospital — Boston, Massachusetts
🧪 Interventions in This Study
- Cognitive Behavioral Therapy - Insomnia (BEHAVIORAL)
- Enhanced Usual Care (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 (1 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (617) 724-6300
Email: hall@mgh.harvard.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.
More studies in Insomnia Chronic
- Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study — Columbia, Missouri
- Targeting Insomnia in School Aged Children With Autism Spectrum Disorder — Columbia, Missouri
- Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study) — Montreal, Quebec
- Sleep Learning Education and Empowerment for Older Korean Immigrants — Los Angeles, California
- SLEEP-COPE: Sleep Intervention for Oppositional Children — Tampa, Florida
Explore by condition: All Insomnia Chronic clinical trials
💡 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.