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

项目总结/摘要 乳腺癌幸存者的心理困扰是非常普遍的，重要的，和昂贵的。研究表明 近一半的乳腺癌幸存者将经历临床上显著的抑郁症状和/或 在癌症诊断后的前五年里，有充分的证据表明，认知行为 CBT治疗是一种有效的干预癌症幸存者的痛苦。不幸的是， 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 应用程序已成为提供低成本保健服务的可行和有效的方法， 信息和治疗。据我们所知，没有公开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以前开发和 验证了一个公开的，完全自动化的应用程序提供的心理健康干预，智能护理，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 并发现它的使用导致抑郁和焦虑症状的显着减少，特别是 在研究入组时具有中等或更高水平痛苦的患者中具有稳健的效果。的积极 从我们的单臂试点结果引导我们到测试智能护理应用程序的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，本项目的目标是：（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 幸存者，和（2）测试人类教练的影响，以增加参与干预的方式。 使用创新的实验设计，称为顺序，多重分配，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提供的患者教育。我们将测试 IntelliCare应用程序在干预后、6个月和12个月随访时对抑郁和焦虑症状的影响（Aim 1）。在应用程序使用的第一周，我们将识别出对IntelliCare应用程序参与度较低的参与者。 这些低风险者将被重新随机化，以接受除应用程序外的指导，而不是无变化（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 与接收IntelliCare应用程序的参与者进行半结构化离职面谈。面试将 捕捉幸存者对定制应用程序和指导的程度和方式的看法 对乳腺癌幸存者的干预可能会改善干预结果和参与度。(Aim 3）。自适应 促进参与的方法，例如为那些努力参与的人提供指导，将平衡 对可扩展性和个性化关注的竞争需求，以解决迅速扩大的生存护理 需求

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.