Evaluating a mobile application to reduce distress in breast cancer survivors using an adaptive design

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Project Summary/Abstract Psychological distress in breast cancer survivors is highly prevalent, significant, and costly. Studies show that nearly half of all breast cancer survivors will experience clinically significant symptoms of depression and/or anxiety in the first five years after their cancer diagnosis. There is robust evidence that cognitive behavioral therapy (CBT) is an efficacious intervention for distress in cancer survivors. Unfortunately, access is significantly limited by a lack of trained clinicians and expense. To overcome these barriers, smartphone applications (`apps') have emerged as a feasible and effective method to provide low-cost delivery of health information and treatment. To our knowledge, there are no publicly available mental health apps that have been rigorously tested with cancer survivors. Members of our research team previously developed and validated a publicly available, fully automated app-delivered mental health intervention, IntelliCare, which is based on tenants of CBT. We recently conducted a pilot of the IntelliCare app suite in breast cancer survivors and found that its use led to a significant reduction in symptoms of depression and anxiety, with particularly robust effects among those with a moderate level of distress or greater upon study enrollment. The positive result from our single-arm pilot leads us to the next logical step of testing the efficacy of the IntelliCare apps against a robust control in a randomized study with long-term follow-up. The goals of this project are: (1) to evaluate the efficacy of the IntelliCare apps in reducing symptoms of depression and anxiety in breast cancer survivors, and (2) to test the impact of human coaching as a way to increase engagement with the intervention. Using an innovative experimental design, called the Sequential, Multiple Assignment, Randomized Trial (SMART), 313 breast cancer survivors with elevated symptoms of depression and anxiety will be randomized to initially receive the IntelliCare apps or app-delivered Patient Education. We will test the effects of the IntelliCare apps on symptoms of depression and anxiety at post intervention, 6 and 12 month follow-up (Aim 1). During the first week of app use, we will identify participants that are low-engagers of the IntelliCare apps. These low-engagers will be re-randomized to receive coaching in addition to the apps vs. no change (i.e., continue using the apps naturally), to test the added value of coaching on engagement (Aim 2). Finally, we will conduct semi-structured exit interviews with participants who receive the IntelliCare apps. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement. (Aim 3). Adaptive approaches to promoting engagement, such as added coaching for those who struggle to engage, will balance the competing needs for scalability and individualized attention to address rapidly expanding survivorship care needs.