Mi Sleep Coach App for Cancer-Related Insomnia

About This Grant

Project Summary Sleep disturbances are highly prevalent among cancer survivors, with rates over 50% reported among breast, prostate, and colorectal cancer survivors.1-3 Sleep disturbances are associated with a range of negative effects on physical and mental health and quality of life.4 High rates of sleep medication use among survivors lead to a range of secondary harms (e.g., fractures, increased mortality).5-7 The underlying mechanisms of sleep disturbance among survivors are multifaceted with cancer and cancer treatment affecting the interplay between psychological (e.g., mood, cancer-related worry, beliefs about sleep), behavioral (e.g., sleep and activity), and physiological (e.g., increased inflammation) factors that influence sleep.8-11 Cognitive behavioral therapy for insomnia (CBT-I) is considered a first line treatment for the general population and survivors,12-17 but access to trained professionals is severely limited.18 Digital delivery of CBT-I (dCBT-I) using internet or mobile technologies has the potential to provide broader access at lower costs.19-21 There is a critical need to assess the efficacy of mobile dCBT-I that is designed for cancer survivors. Our Mi Sleep Coach app is the first to employ survivor-centered design features (e.g., unique human-digital agent interaction to extend the cancer care team, motivational interviewing to address perceived loss of control after cancer diagnosis, just-in-time behavioral activation to modify cancer treatment-related coping behaviors that may interfere with sleep) to deliver core CBT-I strategies. Pilot study results demonstrate high levels of program engagement, highly positive effects on insomnia, markedly reduced use of sleep medications, and specific associations between greater engagement with survivor-centered design features and better sleep. The purpose of this proposal is to rigorously assess the efficacy of the Mi Sleep Coach app. We propose a single-blinded RCT comparing Mi Sleep Coach app to a sleep education attention control app over a 7-week period with a 6-month follow-up. We will enroll a sample of 270 patients who have completed active treatment for breast, prostate or colorectal cancer in the NCI-funded National Clinical Trials Network. The primary outcome is insomnia severity. Secondary outcomes include reduction in the use of sleep medications and regulation of the neuroendocrine-inflammatory axis. Our research team, which has expertise in cancer clinical trials, sleep disorders, digital health, inflammatory markers, and biostatistics, is well positioned to pursue the following specific aims: Aim 1: Evaluate the efficacy of the Mi Sleep Coach app as compared to a sleep education control app to decrease insomnia as measured by the change in the Insomnia Severity Index (ISI). Aim 2: Evaluate the efficacy of the Mi Sleep Coach app as compared to a sleep education control app to decrease self-reported use of sleep medications from baseline to the end of intervention at 7 weeks. Aim 3: Examine mechanisms of intervention effect by assessing function of the neuro-endocrine-inflammatory axis as measured by the downregulation of pro-inflammatory gene expression.