Smart speaker devices have become commonplace in the home and use voice activation to respond to questions, record information, and carry out requests. While these programs provide greater accessibility for some participants, there is potential for alternative delivery methods to better reach and engage more participants. To address this, automated CBT-I delivered via the internet such as SHUTi and Sleepio have been developed and shown to be effective. In-person CBT-I trials in cancer centers have dropout rates of 20–40% despite considerable effort from research staff to engage patients it is likely that in real-world settings non-adherence would be even higher and may be even worse during the current pandemic. However, CBT-I trained practitioners are scarce (even in accredited sleep centers) and a standard regimen of multiple follow-up visits can inhibit completion, particularly among cancer survivors who have a myriad health and financial concerns from cancer treatments. The National Comprehensive Cancer Network and the American College of Physicians recommend cognitive behavioral therapy for insomnia (CBT-I) as the preferred treatment for insomnia. Causes of insomnia are multifaceted, including cancer-related physiological processes, iatrogenic effects of oncotherapies, menopause, and comorbid mood disorders associated with cancer diagnosis and psychosocial and economic stressors. Insomnia can have detrimental impacts on cardiometabolic and immune system health, neurobehavioral function, depression, fatigue, and quality of life, each of which in turn affects mortality. One such complaint, insomnia, is experienced by approximately 30–50% of BCS. However, long-term side effects such as fatigue, insomnia, neuropathy, psychological distress, and cognitive dysfunction may impact quality of life. īreast cancer survivors (BCS) numbered 3.8 million in the United States as of 2019 a number that is growing due to advances in early detection and treatment. Trial Registration NCT05233800 Released. This study will provide evidence on a promising modality to deliver elements of CBT-I for BCS experiencing insomnia. Secondary outcomes include sleep diary outcomes (sleep efficiency, wake after sleep onset, sleep onset latency, total sleep time, and sleep quality). Our primary outcome is the Insomnia Severity Index total score. Control participants will have access to a website with basic information about CBT-I, sleep, and breast cancer survivorship and will be asked to engage with the website as desired. Intervention arm participants will receive a smart speaker device and will be asked to engage with the program daily, using a voice-activated speaker with an accompanying smart-phone app. We will conduct a 6-week, randomized controlled trial with two arms. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30–50% of the 3.8 million BCS in the US.
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