Mi Sleep Coach Mobile App to Address Insomnia Symptoms Among Cancer Survivors: Single-Arm Feasibility Study (Preprint)

Abstract

BACKGROUND Rates of sleep disturbance among survivors of cancer are more than 3 times higher than the general population. Causes of sleep disturbance among survivors are many and multifaceted, including anxiety and fear related to cancer diagnosis and treatments. Cognitive behavioral therapy for insomnia (CBT-I) is considered a first-line treatment for insomnia; However, a lack of access to trained professionals and limited insurance coverage for CBT-I services has limited patient access to these effective treatments. Evidence supports digital delivery of CBT-I (dCBT-I), but there is only limited evidence to support its use among survivors of cancer. Broad adoption of smartphone technology provides a new channel to deliver dCBT-I, but no prior studies have evaluated mobile dCBT-I interventions for survivors. To address the need for accessible and efficacious CBT-I for survivors of cancer, the Mi Sleep Coach program was developed to adapt CBT-I for delivery to survivors of cancer as a self-directed mobile health app. OBJECTIVE This single-arm feasibility study assessed the adherence, attrition, usefulness, and satisfaction of the Mi Sleep Coach app for insomnia. METHODS A 7-week, single-arm study was conducted, enrolling adult survivors of breast, prostate, or colon cancer reporting sleep disturbances. RESULTS In total, 30 participants were enrolled, with 100% completing the study and providing data through week 7. Further, 9 out of 10 app features were found to be useful by 80% (n=24) to 93% (n=28) of the 30 participants. Furthermore, 27 (90%) participants were satisfied with the Mi Sleep Coach app and 28 (93%) would recommend the use of the Mi Sleep Coach app for those with insomnia. The Insomnia Severity Index showed a decrease from baseline (18.5, SD 4.6) to week 7 (10.4, SD 4.2) of 8.1 (<i>P</i><.001; Cohen <i>d</i>=1.5). At baseline, 25 (83%) participants scored in the moderate (n=19; 15-21) or severe (n=6; 22-28) insomnia range. At week 7, a total of 4 (13%) patients scored in the moderate (n=4) or severe (n=0) range. The number of patients taking prescription sleep medications decreased from 7 (23%) at baseline to 1 (3%; <i>P</i><.001) at week 7. The number of patients taking over-the-counter sleep medications decreased from 14 (47%) at baseline to 9 (30%; <i>P</i>=.03) at week 7. CONCLUSIONS The Mi Sleep Coach app demonstrated high levels of program adherence and user satisfaction and had large effects on the severity of insomnia among survivors of cancer. The Mi Sleep Coach app is a promising intervention for cancer-related insomnia, and further clinical trials are warranted. If proven to significantly decrease insomnia in survivors of cancer in future randomized controlled clinical trials, this intervention would provide more survivors of cancer with easy access to evidence-based CBT-I treatment. CLINICALTRIAL ClinicalTrials.gov NCT04827459; https://clinicaltrials.gov/study/NCT04827459