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Clinical Trial 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, and racially and ethnically diverse, demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.


Clinical Trial Description

Guided by the multiphase optimization strategy (MOST) and findings from our pilot RCT (Hall et al., 2022), the 4-session Survivorship Sleep Program will be the used as the basis for optimization. Primary Aim: Optimize the SSP in a 2x2 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). Primary hypothesis: At T2, the combination group delivery + 3 booster sessions will yield larger effects on insomnia vs. individual delivery + no booster sessions. Secondary outcomes are acute (T0-T1; week 4) and 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 actigraphy). Exploratory Aim 1: Characterize study participation and sleep outcomes among racial and ethnic minority cancer survivors with insomnia will be examined by race and by ethnicity (Primary feasibility benchmark: 56% enrolled/eligible). Primary and secondary outcomes across T0-T3 (week 16) will be explored by race and by ethnicity. Exploratory Aim 2: Characterize the acceptability of the SSP design components. Exit interviews (T1) will assess acceptability (enjoyableness, convenience, helpfulness, overall satisfaction) using both Likert ratings (very low=1 to very high=5; benchmarks=4 or higher) and open-ended responses with probes (e.g., most/least for each acceptability item). Exit interviews will also be coded for emergent themes about race and ethnicity to characterize preferences, challenges, and future intervention delivery considerations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06181643
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date February 28, 2026

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