Innovating CBT-I for Cancer Survivors: An Optimization Trial

30-50% of cancer survivors who have completed treatment with curative intent have untreated insomnia. Cancer survivors from diverse racial and ethnic backgrounds experience a higher prevalence of insomnia (vs. non- Hispanic white cancer survivors) yet are underrepresented in cancer survivorship research and sleep clinical trials.

Cognitive behavioral therapy for insomnia (CBT-I) is a first line, evidence-based treatment. Meta-analyses by our group and others have found medium effect size improvements on insomnia, yet barriers to feasibility due to current delivery modalities and lack of targeted content addressing cancer-related barriers to sleep hinder

retention. Our study team developed a synchronous, virtual CBT-I for cancer survivors with 4 weekly sessions delivered to individuals (Survivorship Sleep Program; SSP) and conducted a pilot randomized controlled trial demonstrating feasibility, acceptability, and preliminary efficacy vs. enhanced usual care up to 1-month post-

intervention. However, participants desired enhanced emotional support via a group format or booster sessions, and additional outcomes (emotional distress, work-related functioning, use of sleep medications) were unchanged or not assessed. In response to PAR-21-341, the primary aim of this resubmission is to optimize

synchronous, virtual delivery of the SSP in a 2x2 factorial trial (N=80 cancer survivors with insomnia) to evaluate 2 intervention design components: delivery (individual vs. group) and booster sessions (0 vs. 3). The primary outcome is change in insomnia severity from baseline (T0) to 1-month surveillance/booster 1 (T2).

Exploratory Aim 1 will characterize study participation and sleep outcomes by race and by ethnicity. Feasibility benchmarks established in our previous pilot trial for enrollment (56% enrolled/eligible), retention (90% per timepoint), and attendance (100%) will be examined by race and by ethnicity. Primary and secondary

(emotional distress, work-related functioning, use of sleep medications, sleep diaries, actigraphy) outcomes across timepoints (T0-T3; 3-months surveillance/booster 3) will be explored by race and by ethnicity. Exploratory Aim 2 will characterize the acceptability of the SSP design components via exit interviews

assessed post-SSP (T1) using quantitative ratings and qualitative codes to characterize preferences, challenges, and future delivery considerations. Collectively, this proposal is innovative through its focus on 1) optimizing CBT-I for cancer survivors, 2) testing a scalable, virtually-delivered synchronous intervention, 3)

including key secondary outcomes relevant to cancer survivorship, and 4) engaging community partners to bolster recruitment of racially and ethnically diverse cancer survivors. The proposed strategy is strengthened by a transdisciplinary expert team, partnership with two community organizations serving diverse cancer survivors, a

rigorous framework for optimizing behavioral interventions (Multiphase Optimization Strategy), an evidence- based intervention on which to make adaptations, and use of qualitative and quantitative methods. Findings will inform an R01-level trial and recommendations for addressing insomnia after cancer.