NCT06181643

Innovating CBT-I for Cancer Survivors: An Optimization Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Insomnia is a significant issue in 30-50% of cancer survivors. Our pilot randomized controlled trial of synchronous, virtual cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors suggested that a group format or booster sessions may optimize effects on insomnia and daytime functioning. The goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. We will conduct a 2×2 factorial trial (N=80) to evaluate the optimal combination of two intervention design components: delivery (individual vs. group) and booster sessions (0 vs 3). The primary outcome is change in insomnia severity (insomnia severity index) from T0 (week 0) to T2 (week 8). The secondary outcomes are acute (T0-T1, week 4) and sustained (T0-T3, week 16) changes in insomnia severity, emotional distress, work-related functioning, use of sleep medications, and subjective and objective sleep metrics (measured with sleep diaries and Fitbit). Exploratory aim 1 is to characterize study participation and sleep outcomes among cancer survivors with insomnia. Exploratory aim 2 is to characterize the acceptability of design components using Likert ratings (very low=1 to very high=5, benchmarks=4 or higher) and exit interviews with open-ended responses with probes. This 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 among the steadily increasing number of cancer survivors.

Conditions

• Cancer Survivorship
• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-06
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2023-12-26
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States