Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors

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Project Summary/Abstract Insomnia symptoms occur in one-third of the general population and 10-15% meet criteria for insomnia disorder, marked by chronic sleep disturbances that cause devastating effects on health, function and well- being. Symptoms and side effects of cancer and cancer treatments render cancer survivors at increased risk for insomnia disorder. An estimated 40% of cancer survivors report sleep disturbances years after completing treatment. To date, little research exists on strategies to effectively reduce insomnia in cancer survivors, especially in the application of cognitive behavioral therapy for insomnia (CBT-I) at the bedside by nurses. Research in non-cancer populations revealed that CBTI is safe, efficacious, and durable. However, CBTI is not widely available due to a lack of trained professionals and the high cost of treatment. Thus, a major gap in the field of oncology is an alternative to CBTI that is nurse-delivered, rigorously tested, low cost, durable, and having high treatment fidelity. As such, the current objective is to determine efficacy and durability of a streamlined nurse-delivered version of CBTI, specifically Brief Behavioral Therapy for Insomnia (BBTI), using a large heterogeneous sample of cancer survivors. This study proposes a multi-tiered, translational approach to address insomnia in cancer survivors. Aim 1 will determine the efficacy of a manualized BBTI treatment protocol in cancer survivors compared to an attention control previously developed by this team. Aim 2 of the study will determine predictors for efficacy of BBTI to inform future eligibility criteria in dissemination and implementation research. Aim 3 will evaluate BBTI implementation with a focus on characterization of the patient- and provider-level facilitators and barriers. One hundred fifty-eight cancer survivors will be randomized to either BBTI or attention control. Sleep, mood, functional status and quality of life will be evaluated before, 1- month, 3-months and 12-months after the interventions. The primary outcome will be self-reported insomnia severity using the Insomnia Severity Index at 1-month while durability of the intervention will be examined at 3- months and 12-months post treatment. This proposal provides an opportunity for the first time to test the efficacy and durability of a self-management behavioral intervention for cancer survivors with insomnia in order to reduce disease burden and disability, improve well-being, strengthen self-determination and participation in health care, and prevent illness and complications. Thus, the rapid translation to clinical application makes this appealing on the clinical front but has significant promise at the individual patient level as well.