Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

Background: 30-50% of cancer survivors have untreated insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is a first line, evidence-based treatment that is currently limited by few delivery options, lack of targeted content addressing cancer-related barriers to sleep, and limited testing by survivorship phase. With ACS pilot funding, the investigators previously developed a synchronous, virtual CBT-I program for cancer survivors (Survivorship Sleep Program; SSP) and conducted a pilot RCT demonstrating its feasibility, acceptability, and preliminary efficacy vs. enhanced usual care (EUC; CBT-I referral + sleep hygiene handout). The SSP, delivered in 6 weeks via 4 sessions + 1 booster session, is now ready for efficacy testing with a large, diverse sample including survivors who have completed primary treatment with curative intent (i.e., curvivors), survivors currently in treatment, and survivors living with metastatic cancer (i.e., metavivors).

Objective/Hypothesis: Our primary hypothesis is that the SSP (vs. EUC) will lead to significant reductions in cancer survivors' insomnia severity and secondary sleep-related outcomes.

Specific Aims: Aim 1 is to evaluate the efficacy of the SSP (vs. EUC) on the primary outcome change in insomnia severity (Insomnia Severity Index) from T0 (baseline) to T2 (4-week follow-up/10 weeks). Aim 2 is to examine changes from T0 though T3 (12-week follow-up/18 weeks) in outcomes commonly associated with cancer-related insomnia, including sleep diary and actigraphy sleep metrics (e.g., sleep efficiency), emotional distress (i.e., PROMIS depression and anxiety), daytime fatigue, use of sleep medications. Aim 3 is to characterize potential differences by cancer survivorship phase.

Study Design: The investigators propose to conduct a fully powered efficacy RCT (N=198, 1:1) evaluating the SSP (n=99) vs. EUC (n=99) among cancer survivors with insomnia. All study delivery and data collection will be conducted virtually and in close partnership with SurvivorJourneys and Ellie Fund, our community partners on this proposal. Enrollment will be stratified by 3 phases of cancer survivorship (n=66/phase, balanced between study arms). Assessments will occur at T0, T1 (6 weeks), T2, and T3. Group-by-time effects will be explicated by survivorship phase. Exit interviews assessing acceptability (enjoyableness, convenience, helpfulness, overall satisfaction) will be coded deductively (e.g., most/least) and inductively (e.g., preferences, challenges, and future delivery considerations) to extract themes by survivorship phase.

Relevance: Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an efficacious, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.

• PROMIS anxiety short form [Срок оценки: Baseline, Week 6, week 10, and week 18]
• PROMIS depression short form [Срок оценки: Baseline, week 6, week 10, and week 18]
• PROMIS fatigue short form [Срок оценки: baseline, week 6, week 10, and week 18]
• Use of sleep aid meditations [Срок оценки: baseline, week 6, week 10, and week 18]
• Perceived Cognitive Impairment subscale of The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) [Срок оценки: baseline, week 6, week 10, and week 18]
• Sleep diaries and actigraphy/Fitbit [Срок оценки: baseline, week 6, week 10, and week 18]
• Smoking [Срок оценки: baseline, week 6, week 10, and week 18]
• International Physical Activity Questionnaire [Срок оценки: baseline, week 6, week 10, and week 18]
• Perceived weight changes [Срок оценки: baseline, week 6, week 10, and week 18]
• Fear of Cancer Recurrence Inventory-Severity subscale [Срок оценки: baseline, week 6, week 10, and week 18]