Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence

用于管理症状和提高辅助内分泌治疗依从性的通信应用程序

• 批准号: 9768995
• 负责人: Ilana Graetz
• 金额: $ 42.43万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768995
• 关键词: Adherence; Adjuvant; Adverse effects; Breast Cancer Patient; Cancer Center; Caring; Cellular Phone; Client satisfaction; Clinic Visits; Communication; Computers; Control Groups; Data; Devices; Electronic Health Record; Enrollment; Feedback; Goals; Health; Health Care Costs; Hospitalization; Insurance Carriers; Intervention; Malignant Neoplasms; Measures; Medical Care Team; Monitor; Office Visits; Operative Surgical Procedures; Outcome; Participant; Patient Care; Patient Care Team; Patient Noncompliance; Patient-Focused Outcomes; Patients; Pilot Projects; Policy Maker; Provider; Quality of life; Radiation; Randomized; Randomized Controlled Trials; Recurrence; Reporting; Research; Resources; Risk; Sampling; Survival Rate; Symptoms; System; Tablets; Tennessee; Testing; Time; Time Management; Treatment outcome; Urban Population; Visit; Woman; adherence rate; arm; base; cancer recurrence; cancer risk; chemotherapy; clinical practice; cost; design; experience; health care service utilization; hormone receptor-positive; hormone therapy; improved; intervention effect; malignant breast neoplasm; medication compliance; mortality; mortality disparity; oncology; patient-clinician communication; pilot trial; racial disparity; real time monitoring; side effect; success; symptom management; therapy adherence; three-arm study; treatment as usual; trend; web-enabled

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.

对于马龙受体阳性乳腺癌的女性，长期使用可调节的内分泌治疗（AET） 大大降低了住院，癌症复发和死亡率的风险，并提高了生活质量。 尽管AET具有已知的好处，但由于不良副作用，许多患者不遵守。此外， 黑人妇女的依从性较低可能会导致死亡率的庞大分布 结果。实时监测与治疗相关的广告症状和依从性可能会导致更多 有效治疗症状，较高的药物依从性以及最终降低复发性和 死亡。然而，迄今 有针对性的症状管理是提高依从性的一种手段，其中没有一个发现 对依从性的统计学意义。我们提出的研究将通过测试网络来填补这一研究差距 启用的应用程序设计具有改善长期AET依从性的明确目标。患者报告的符号 将直接与患者的电子健康记录集成，以改善患者提供者 有关AET依从性和相关广告症状的沟通。在小型飞行员中 研究应用程序的试验，我们发现最近启动新AET并每周收到的参与者 提醒使用该应用的提醒报告，与对照相比，在8周时对AET的依从 组（91％比68％，p = 0.02）。拟议的研究以我们的试点研究的成功为基础：1）扩展 干预期限到六个月，以捕获后来发出的广告符号，这些符号较慢 发展; 2）跟随参与者一到三年，具体取决于入学年份，以测试长期 干预对药物依从性和其他结果的影响； 3）包括更大的样本 有动力测试多个干预措施。我们将将300名参与者随机为三个臂之一：1） 一个“应用程序”组（n = 100），将每周提醒使用PCM应用程序； 2）“应用+反馈”组 （n = 100）将根据其对应用程序的使用获得每周的提醒和个性化反馈；或3）a “通常的护理”组（n = 100），只能接受通常的护理。该应用将包括有关AET的问题 如果有的话 报告症状或趋势。我们假设监测症状和依从性 警报和对患者的反馈报告将导致及时的症状管理和更高的长期 遵守AET的术语。通过评估干预措施对一套综合措施的影响， 包括AET依从性，患者结果，种族分布和与资源使用相关的成本，我们的研究将 为提供者，政策制定者和确保努力实现的价值和可行的结果 “三重目标” - 降低成本，同时改善健康成果和患者体验。