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

项目概要/摘要 乳腺癌幸存者的心理困扰非常普遍、严重且代价高昂。研究表明 近一半的乳腺癌幸存者会出现临床上显着的抑郁症状和/或 癌症诊断后头五年的焦虑。有强有力的证据表明认知行为 疗法（CBT）是缓解癌症幸存者痛苦的有效干预措施。不幸的是，访问是 由于缺乏训练有素的临床医生和费用而受到严重限制。为了克服这些障碍，智能手机 应用程序（“apps”）已成为提供低成本医疗服务的可行且有效的方法 信息和治疗。据我们所知，没有任何公开的心理健康应用程序具有 经过癌症幸存者的严格测试。我们的研究团队成员之前开发并 验证了一种公开可用的、完全自动化的应用程序提供的心理健康干预措施 IntelliCare， 基于CBT的租户。我们最近在乳腺癌幸存者中进行了 IntelliCare 应用程序套件试点 并发现它的使用可以显着减轻抑郁和焦虑症状，尤其是 对入组时有中度或以上痛苦的人有显着影响。积极的一面 我们的单臂试验结果引导我们进行下一个合乎逻辑的步骤：测试 IntelliCare 应用程序的功效 与长期随访的随机研究中的稳健对照相比。该项目的目标是：（1） 评估 IntelliCare 应用程序在减少乳腺癌抑郁和焦虑症状方面的功效 幸存者，(2) 测试人类辅导的影响，作为增加干预参与度的一种方式。 使用创新的实验设计，称为序贯、多重分配、随机试验 (SMART)，313 名抑郁和焦虑症状加重的乳腺癌幸存者将被随机分组 最初接收 IntelliCare 应用程序或应用程序提供的患者教育。我们将测试一下效果 IntelliCare 应用程序在干预后、6 个月和 12 个月的随访中针对抑郁和焦虑症状（目标 1）。在应用程序使用的第一周，我们将识别 IntelliCare 应用程序参与度较低的参与者。 这些低参与度的人将被重新随机分配，除了应用程序之外还接受辅导与不进行任何改变（即， 继续自然地使用应用程序），以测试参与度辅导的附加价值（目标 2）。最后，我们将 对收到 IntelliCare 应用程序的参与者进行半结构化退出访谈。面试将 捕捉幸存者对具体定制应用程序和辅导的程度和方式的看法 对于乳腺癌幸存者来说可能会改善干预结果和参与度。 （目标 3）。自适应 促进参与的方法，例如为那些难以参与的人提供额外的指导，将平衡 对可扩展性和个性化关注的竞争需求，以解决快速扩大的幸存者护理问题 需要。

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.