| Title: |
Efficacy of synchronous, virtual cognitive behavioral therapy for insomnia across phases of cancer survivorship: a study protocol |
| Authors: |
Willis, Kelcie D.; Balkind, Emma G.; Bolden, Caleb; Muzikansky, Alona; Gorman, Mark J.; Comander, Amy; Wagner, Lynne; Kossowsky, Joe; Park, Elyse R.; Mukhammadov, Timur; Adewumi, Tolulope; Nies, Brandon; Hall, Daniel L. |
| Source: |
International Journal of Clinical Trials; Vol. 12 No. 4 (2025): October-December 2025; 313-322 ; 2349-3259 ; 2349-3240 |
| Publisher Information: |
Medip Academy |
| Publication Year: |
2025 |
| Subject Terms: |
Insomnia; Cancer; Survivorship; Randomized Controlled Trial; Cognitive behavioral therapy; Sleep |
| Description: |
Background: Chronic insomnia affects up to 50% of cancer survivors, contributing to emotional distress, fatigue, and reduced quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment, yet access remains limited, particularly for cancer survivors across different phases of survivorship. This study evaluates the efficacy of a synchronous, virtual CBT-I intervention targeted for cancer survivors survivorship sleep program (SSP) across curvivors, those in active treatment, and metavivors. Methods: This randomized controlled efficacy trial will enroll 198 cancer survivors with clinically significant insomnia and will randomize participants 1:1 to the SSP (n=99) or enhanced usual care (EUC; n=99). SSP consists of four weekly 45-minute sessions and one booster session at week 6. The primary outcome is change in insomnia severity (ISI) from baseline (T0) to week 10 (T2). Secondary outcomes include subjective (sleep diary) and objective (Fitbit) sleep metrics, emotional distress, fatigue, sleep medication use, perceived cognitive functioning, work presenteeism/absenteeism, and health behaviors, assessed acutely (week 6; T1) and 3-months post-SSP (week 18; T0-T3). Exploratory outcomes include acceptability metrics and treatment effects by survivorship phase. Conclusions: This trial addresses major gaps in the CBT-I literature by evaluating key subjective and objective sleep outcomes for cancer survivors across various phases of treatment. Findings will inform the scalable delivery of CBT-I in oncology, advancing access to evidence-based insomnia care. Trial registration: NCT06181643. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://www.ijclinicaltrials.com/index.php/ijct/article/view/922/499; https://www.ijclinicaltrials.com/index.php/ijct/article/view/922 |
| DOI: |
10.18203/2349-3259.ijct20253337 |
| Availability: |
https://www.ijclinicaltrials.com/index.php/ijct/article/view/922; https://doi.org/10.18203/2349-3259.ijct20253337 |
| Rights: |
Copyright (c) 2025 International Journal of Clinical Trials |
| Accession Number: |
edsbas.E83BFA7D |
| Database: |
BASE |