Innovating CBT-I for Cancer Survivors: An Optimization Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Innovating CBT-I for Cancer Survivors: An Optimization Trial

Conditions
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Cancer Survivorship, Insomnia

Intervention / Treatment
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* Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions
* Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions
* Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions
* Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions


Participation Criteria
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Eligibility Criteria
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Inclusion criteria include: (1) History of nonmetastatic, localized, or regional solid or blood malignancy(ies); (2) Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy); (3) 18 years of age or older; and (4) Chronic insomnia (DSM-5 criteria and elevated Insomnia Severity Index score >= 15). Exclusion criteria include: (1) Self-reported inability to speak and write in English; (2) Undertreated noninsomnia sleep disorder (e.g., sleep apnea); (3) Undertreated epilepsy, serious mental illness, or suicidality, and/or psychiatric hospitalization in the past year; and/or (4) Unwilling or unable to discontinue night shift work.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions<br>4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions. | Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions<br>* 4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.<br>|
| Experimental: Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions<br>4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions. | Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions<br>* 4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.<br>|
| Experimental: Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions<br>4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions. | Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions<br>* 4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.<br>|
| Experimental: Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions<br>4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions. | Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions<br>* 4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) total score | 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. | T0 (Baseline) to T2 (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional distress: PROMIS Anxiety Symptoms | PROMIS anxiety short form. Acute (T0-T1; week 4) and 3-month (T0-T3; week 16) changes will be examined as secondary outcomes. | T0 (week 0) to T3 (week 16) | 
| Emotional distress: PROMIS Depression Symptoms | PROMIS depression short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes. | T0 (week 0) to T3 (week 16) | 
| Daytime fatigue: PROMIS Fatigue | PROMIS fatigue short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes. | T0 (week 0) to T3 (week 16) | 
| Work-related functioning | 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. | T0 (week 0) to T3 (week 16) | 
| Use of sleep aid medications | 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. | T0 (week 0) to T3 (week 16) | 
| Sleep diaries and actigraphy | 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. | T0 (week 0) to T3 (week 16) |