4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions.

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions.

Survivorship Sleep Program with Individual Delivery + No Booster Sessions

Survivorship Sleep Program with Group Delivery + No Booster Sessions

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.

Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.

Survivorship Sleep Program with Group Delivery + 3 Booster Sessions

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.

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.

Innovating CBT-I for Cancer Survivors: An Optimization Trial

Changes in insomnia severity will be assessed using the validated Insomnia Severity Index (ISI). Scores of 15 or higher on the ISI indicate clinically significant insomnia, and reductions of \>8 points are considered clinically meaningful. Changes from T0-T2 are the primary outcome. Acute (T0-T1; post-SSP) and 3-month (T0-T3; 3 Month Surveillance/Booster 3) changes will be examined as secondary outcomes.

PROMIS anxiety short form. Acute (T0-T1; week 4) and 3-month (T0-T3; week 16) changes will be examined as secondary outcomes.

PROMIS depression short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.

PROMIS fatigue short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.

Work-related functioning will be measured using the six-item Work Productivity and Activity Impairment: General Health (WPAI:GH), which includes scores for absenteeism, presenteeism, and total work impairment. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.

Use of sleep aid medications (frequency, dose) will be evaluated via self-report surveys and electronic medical records (when possible). Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.

Sleep diaries and actigraphy will be collected during SSP Sessions 1-4 and for 7 days at each timepoint (T0-T3) to derive sleep efficiency, sleep onset latency, and wake after sleep onset. Discrepancy scores between subjective and objective sleep metrics (e.g., sleep onset latency) will be examined. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Innovating CBT-I for Cancer Survivors: An Optimization Trial	NCT06181643	Cancer Survivor... Insomnia	Survivorship Sl... Survivorship Sl... Survivorship Sl... Survivorship Sl...	18 Years -	Massachusetts General Hospital
Innovating CBT-I for Cancer Survivors: An Optimization Trial	NCT06181643	Cancer Survivor... Insomnia	Survivorship Sl... Survivorship Sl... Survivorship Sl... Survivorship Sl...	18 Years -	Massachusetts General Hospital

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