Innovating CBT-I for cancer survivors: study protocol for a randomized controlled optimization trial

Emma G. Balkind; Kelcie D. Willis; Caleb Bolden; Alona Muzikansky; Mark J. Gorman; Amy H. Comander; Dana Haggett; Lynne Wagner; Joe Kossowsky; Elyse R. Park; Timur Mukhammadov; Tolulope Adewumi; Daniel L. Hall

doi:10.18203/2349-3259.ijct20251208

Authors

Emma G. Balkind Massachusetts General Hospital, Boston, MA, United States
Kelcie D. Willis Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States
Caleb Bolden Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States
Alona Muzikansky Massachusetts General Hospital, Boston, MA, United States
Mark J. Gorman Massachusetts General Hospital, Boston, MA, United States
Amy H. Comander Massachusetts General Hospital, Boston, MA, United States
Dana Haggett Massachusetts General Hospital, Boston, MA, United States
Lynne Wagner Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, United States
Joe Kossowsky Harvard Medical School, Boston, MA, United States; Boston Children’s Hospital, Boston, MA, United States
Elyse R. Park Massachusetts General Hospital, Boston, MA, United States
Timur Mukhammadov Massachusetts General Hospital, Boston, MA, United States
Tolulope Adewumi Massachusetts General Hospital, Boston, MA, United States
Daniel L. Hall Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States

DOI:

https://doi.org/10.18203/2349-3259.ijct20251208

Keywords:

Insomnia, CBT-I, Survivorship, Cancer, Oncology, Optimization, MOST

Abstract

Background: 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.

Methods: 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 racial and ethnic minority 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.

Conclusions: 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.

Trial Registration: NCT06181643.

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