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.

对于患有激素受体阳性乳腺癌的女性，长期使用辅助内分泌治疗（AET） 显着降低住院、癌症复发和死亡率的风险，并提高生活质量。 尽管 AET 具有已知的益处，但许多患者由于不良副作用而不依从。 黑人妇女的依从性较低可能导致死亡率差异巨大且不断扩大 实时监测与治疗相关的不良症状和依从性可能会带来更多结果。 有效管理症状，提高用药依从性，最终降低复发率和 然而，迄今为止，只有少数干预措施旨在提高 AET 依从性，很少有干预措施能够做到这一点。 有针对性的症状管理作为提高依从性的一种手段，其中，没有人发现 我们提出的研究将通过测试网络来填补这一研究空白。 启用的应用程序设计的明确目标是改善长期 AET 依从性。 将直接与患者的电子健康记录集成，以改善患者提供者 在一次小型试点中就 AET 依从性和相关不良症状进行沟通。 在研究应用程序的试用中，我们发现最近发起新 AET 并每周接受一次的参与者 使用该应用程序的提醒报告显示，与对照组相比，第 8 周时对 AET 的依从性显着提高 组（91% vs. 68%，p=0.02）。拟议的研究建立在我们试点研究成功的基础上：1）扩大了范围。 干预期为六个月，以便捕捉较晚发生的不良症状 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果的影响；3) 包括更大的样本 我们将随机将 300 名参与者分配到三个组之一：1) “应用程序”组 (n=100) 将每周收到使用 PCM 应用程序的提醒 2) “应用程序 + 反馈”组； (n=100) 将根据应用程序的使用情况收到每周提醒和个性化反馈；或 3) 仅接受常规护理的“常规护理”组 (n=100) 该应用程序将包含有关 AET 的问题。 依从性和不良症状，如有任何问题，内置警报会发送给患者的护理团队 我们力争通过可操作的方式监测症状和依从性。 向患者发出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高的长期治疗效果 长期坚持 AET 通过评估干预措施对一系列综合措施的影响， 包括 AET 依从性、患者结果、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提供商、政策制定者和保险公司提供有价值且可行的结果 “三重目标”——降低成本，同时改善健康结果和患者体验。