Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence

对于激素受体阳性的乳腺癌女性，长期使用辅助内分泌治疗(AET) 显著降低住院、癌症复发和死亡率的风险，并提高生活质量。 尽管已知AETs的好处，但许多患者因不良副作用而不依从性。此外， 黑人女性中较低的依从性可能是造成死亡率差异巨大且不断扩大的原因之一 结果。实时监测与治疗相关的不良症状和坚持治疗可能会导致更多 有效的症状管理，更高的用药依从性，并最终降低复发和 死亡率。然而，到目前为止，只有少数干预措施旨在改善AET的遵从性，很少有这样的干预措施 有针对性的症状管理作为提高依从性的一种手段，而在这些方法中，没有一种找到 对遵从性有统计上的显著影响。我们提议的研究将通过测试网络来填补这一研究空白- 启用APP的设计明确目标是提高AET的长期遵从性。患者报告的症状 将直接与患者的电子健康记录集成，以改善患者提供者 在门诊之外就AET依从性和相关不良症状进行沟通。在一个小型飞行员中 对研究应用程序的试用，我们发现最近启动了新的AET并每周收到 使用该应用程序的提醒报告显示，与对照组相比，8周时对AETs的依从性显著更高 组(91%vs.68%，P=0.02)。拟议的研究建立在我们先导研究的成功基础上：1)扩展 将干预期延长至6个月，以便捕捉到较晚发病的不良症状 发展；2)根据注册年份，对参与者进行一到三年的跟踪，以测试较长期的 干预对服药依从性和其他结果的影响；3)包括更大的样本 有能力测试多个级别的干预。我们将300名参与者随机分配到三组中的一组：1) 每周将收到使用PCM应用程序的提醒的“应用程序”群组(n=100)；2)“应用程序+反馈”群组 (n=100)将根据其应用程序的使用情况接收每周提醒和个性化反馈；或3)a “常规护理”组(n=100)，将只接受常规护理。该应用程序将包括有关AET的问题 依从性和不良症状，内置警报发送给患者的护理团队，如果有任何问题 报告症状或趋势。我们假设监测症状和坚持使用可操作的 对患者的警报和量身定制的反馈报告将导致更及时的症状管理和更长的时间 遵守AET的条款。通过评估干预措施对一套全面措施的影响， 包括AET依从性、患者结局、种族差异和与资源使用相关的成本，我们的研究将 为努力实现以下目标的提供者、政策制定者和保险公司提供有价值和可操作的结果 “三重目标”--在降低成本的同时改善健康状况和患者体验。

For women with hormone receptor-positive breast cancer, long-term use of adjuvant endocrine therapy (AET) significantly reduces the risk of hospitalizations, cancer recurrence and mortality, and increases quality of life. Despite the known benefits of AETs, many patients are nonadherent due to adverse side effects. Furthermore, lower adherence among black women may be contributing to the large and growing disparities in mortality outcomes. Real-time monitoring of treatment-related adverse symptoms and adherence could result in more effective management of symptoms, higher medication adherence, and ultimately lower recurrence and mortality. To date, however, only a few interventions have aimed to improve AET adherence, few have targeted symptom management as a means to improve adherence, and of these, none have found a statistically significant impact on adherence. Our proposed study will fill this research gap by testing a web- enabled app designed with the explicit goal of improving long-term AET adherence. Patient-reported symptoms will be integrated directly with the patient's electronic health record in order to improve patient-provider communication about AET adherence and related adverse symptoms outside of clinic visits. In a small pilot trial of the study app, we found that participants who had recently initiated a new AET and received weekly reminders to use the app reported significantly higher adherence to AETs at 8 weeks compared with a control group (91% vs. 68%, p=0.02). The proposed study builds on the success of our pilot study by: 1) expanding the intervention period to six months in order to capture later-onset adverse symptoms that are slower to develop; 2) following participants for one to three years, depending on enrollment year, to test longer-term effects of the intervention on medication adherence and other outcomes; and 3) including a larger sample powered to test multiple levels of the intervention. We will randomize 300 participants to one of three arms: 1) an “App” group (n=100) that will receive weekly reminders to use the PCM app; 2) an “App+Feedback” group (n=100) that will receive weekly reminders and personalized feedback based on their use of the app; or 3) a “Usual Care” group (n=100) that will receive usual care only. The app will include questions about AET adherence and adverse symptoms with built-in alerts sent to the patient's care team if any concerning symptoms or trends are reported. We hypothesize that monitoring symptoms and adherence with actionable alerts and tailored feedback reports to patients will result in timelier symptom management and higher long- term adherence to AET. By evaluating the impact of the intervention on a comprehensive set of measures, including AET adherence, patient outcomes, racial disparities and resource use-related costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the “Triple Aim” – reduce costs while improving health outcomes and the patient experience.