Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence

对于激素受体阳性乳腺癌的女性，长期使用辅助内分泌治疗（AET） 显著降低住院、癌症复发和死亡的风险，并提高生活质量。 尽管已知的好处，许多患者是不遵守由于不良副作用。此外，委员会认为， 黑人妇女的低依从性可能导致死亡率的巨大和不断增长的差异 成果。实时监测治疗相关的不良症状和依从性可能会导致更多的 有效管理症状，提高药物依从性，最终降低复发率， mortality.然而，到目前为止，只有少数干预措施旨在改善AET依从性，很少有 有针对性的症状管理作为一种手段，以提高依从性，其中，没有发现一个 对依从性的统计学显著影响。我们提出的研究将通过测试一个网络来填补这一研究空白- 这是一款旨在提高长期AET依从性的明确目标的应用程序。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 关于AET依从性和临床访视以外的相关不良症状的沟通。在一个小试点 在研究应用程序的试用中，我们发现最近启动新AET并每周接受一次AET的参与者 与对照组相比，提醒使用应用程序的患者在8周时对Askin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的试点研究的成功基础上，通过：1）扩大 干预期为6个月，以捕捉迟发性不良症状， 发展; 2）根据入学年份，跟踪参与者一到三年，以进行长期测试 干预对药物依从性和其他结局的影响;以及3）包括更大的样本 测试多个层次的干预措施。我们将300名参与者随机分为三组：1） 一个“应用程序”组（n=100），每周收到使用PCM应用程序的提醒; 2）一个“应用程序+反馈”组 （n=100）将根据他们对应用程序的使用情况收到每周提醒和个性化反馈;或3）a “家庭护理”组（n=100），仅接受常规护理。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） 报告症状或趋势。我们假设，监测症状和遵守与可操作的 警报和定制的反馈报告给患者将导致更及时的症状管理和更高的长期- 长期坚持AET。通过评估干预措施对一整套措施的影响， 包括AET依从性、患者结局、种族差异和资源使用相关成本，我们的研究将 为努力实现以下目标的供应商、政策制定者和保险公司提供有价值的可操作结果： “三重目标”-降低成本，同时改善健康结果和患者体验。

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.