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

项目摘要/摘要 乳腺癌幸存者的心理痛苦是非常普遍的、严重的和昂贵的。研究表明， 近一半的乳腺癌幸存者将经历临床上明显的抑郁和/或症状 在癌症确诊后的头五年里，他们感到焦虑。有确凿的证据表明认知行为 治疗(CBT)是治疗癌症幸存者痛苦的有效干预措施。不幸的是，Access是 严重受限于缺乏训练有素的临床医生和费用。为了克服这些障碍，智能手机 应用程序(应用程序)已成为提供低成本健康服务的一种可行而有效的方法 信息和治疗。据我们所知，目前还没有公开可用的心理健康应用程序 在癌症幸存者身上进行了严格的测试。我们的研究团队成员之前开发了和 验证了公开提供的、由应用程序提供的全自动化心理健康干预，IntelliCare，这是 基于CBT的租户。我们最近在乳腺癌幸存者中进行了IntelliCare应用程序套件的试点 并发现使用它可以显著减少抑郁和焦虑的症状，尤其是 在入学时有中度或更严重痛苦的人会产生强烈的影响。积极的一面 单臂试验的结果将我们引向测试IntelliCare应用程序有效性的下一个合乎逻辑的步骤 在一项长期随访的随机研究中，对照稳健的对照。这项计划的目标是：(1) 评估IntelliCare应用程序在减轻乳腺癌患者抑郁和焦虑症状方面的疗效 以及(2)测试人类教练的影响，以此作为增加干预参与的一种方式。 使用一种创新的实验设计，称为序贯、多任务、随机试验 (SMART)，313名抑郁和焦虑症状升高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交付的患者教育。我们将测试 IntelliCare应用程序在干预后、6个月和12个月随访(目标)时的抑郁和焦虑症状 1)。在应用程序使用的第一周，我们将确定IntelliCare应用程序的低参与度参与者。 这些低参与度的参与者将被重新随机化以接受除应用程序之外的指导(即， 继续自然地使用这些应用程序)，以测试参与度指导的附加值(目标2)。最后，我们会 对接受IntelliCare应用程序的参与者进行半结构化离职访谈。采访将会 捕捉幸存者对应用程序和指导的具体定制程度和方式的看法 对于乳腺癌幸存者来说，这可能会改善干预结果和参与度。(目标3)。适应性 促进参与的方法，如为那些难以参与的人提供额外的指导，将会取得平衡 对可扩展性和个性化关注的相互竞争的需求，以应对迅速扩大的生存护理 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.