Innovating CBT-I for Cancer Survivors: An Optimization Trial
NCT06181643 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-05-08
Summary
The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.
Conditions
- Cancer Survivorship
- Insomnia
Interventions
- BEHAVIORAL
-
Survivorship Sleep Program with Individual Delivery + No Booster Sessions
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.
- BEHAVIORAL
-
Survivorship Sleep Program with Group Delivery + No Booster Sessions
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.
- BEHAVIORAL
-
Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.
- BEHAVIORAL
-
Survivorship Sleep Program with Group Delivery + 3 Booster Sessions
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Daniel Hall, PhD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-06
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United States
Study Locations
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