Improving medication adherence using a CONnected CUstomized Treatment Platform (CONCURxP)

项目总结 细胞周期蛋白依赖性激酶4/6抑制剂(CDK4/6I)几乎使无进展生存率增加一倍，并增加 激素受体阳性(HR)的人表皮在内分泌治疗中的总存活率 生长因子受体2阴性(HER2-)转移性乳腺癌。MBC的发病率不断增长 在年轻女性中强调需要优化对复杂药物治疗方案的坚持，事实证明 提高存活率。CDK4/6iS复杂的给药程序以及高昂的成本被认为是导致 不遵守。CDK4/6I不依从性对生存、症状的影响的证据有限 负担，或生活质量。随着医疗保健向远程医疗的更大依赖过渡，以及 短信手机在各个阶层的普及率不断提高，我们建议 测试创新的个性化多层次mHealth干预，通过实施 互联定制治疗平台(CONCURxP)与增强型治疗平台的随机对照试验 常规护理(EUC)。CONCURxP试验将招募390名讲英语或西班牙语的成年HR女性 HER2-MBC和CDK4/6i的新处方，他们有一部可以发短信的手机，而且 在参与的NCI社区肿瘤学研究计划(NCORP)实践中接受治疗。至 客观地衡量CDK4/6i的依从性，所有入选患者都将收到一个智能药盒。CONCURxP臂 除了常规护理外，患者还将：(1)收到错过或额外剂量的自动短信提醒 由智能地堡发出信号；(2)回复短信，说明每次CDK4/6i非 依从性；以及(3)可以在研究门户网站上查看剂量历史。遗漏或双倍剂量超过 预定义阈值将触发向肿瘤学提供者团队的指定成员发送电子邮件通知， 谁将被提示联系患者以解决该问题以关闭通信环路。如果 不遵守是由于成本，提供者将接受培训，将患者转介给患者权益倡导基金会，一个 国家非营利性金融导航计划。EUC患者将可以获得教育材料 完善副作用管理。患者将接受为期12个月的干预，并在 基线、注册后3个月、6个月和12个月。我们的目标是：(1)比较CDK4/6i的依从性；以及(2) 患者报告的结果(PRO)，包括症状负担、生活质量、患者与提供者的沟通、 在CONCURxP和EUC ARMS之间12个月的症状管理自我效能感和经济担忧； (3)使用混合方法描述患者和提供者在CONCURxP干预下的体验；以及 (4)探讨CONCURxP患者的医疗保健利用率、无进展和12个月的总生存期 与EUC相比。主要终点是12个月的依从性，定义为患者的天数比例 按规定频率摄取CDK4/6I，药盒测量。我们的新型多层次移动健康 干预将提供有价值和可操作的结果，以改善健康结果和患者体验。

PROJECT SUMMARY Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) nearly doubles progression-free survival and increases overall survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2–negative (HER2-) metastatic breast cancer (MBC). The growing incidence of MBC among younger women highlights the need to optimize adherence to complex medication regimens proven to increase survival. The complex dosing schedule of CDK4/6is along with high cost is thought to contribute to non-adherence. There is limited evidence on the impact of CDK4/6i nonadherence on survival, symptom burden, or quality of life. As healthcare transitions to a greater dependence on telemedicine, and with the increasing penetration of text-enabled mobile phones across every segment of the population, we propose to test an innovative personalized multilevel mHealth intervention to improve CDK4/6i adherence by conducting a randomized controlled trial of a CONnected CUstomized Treatment Platform (CONCURxP) versus enhanced usual care (EUC). The CONCURxP trial will recruit 390 English- or Spanish- speaking adult women with HR+ HER2- MBC and a new prescription for a CDK4/6i, who have a mobile phone with text messaging and are treated in one of the participating NCI Community Oncology Research Program (NCORP) practices. To objectively measure CDK4/6i adherence, all enrolled patients will receive a smart pillbox. CONCURxP arm patients in addition to usual care will: (1) receive automated text reminders for missed or extra doses that are signaled by the smart pillbox; (2) respond to text messages citing the reason for each incident of CDK4/6i non- adherence; and (3) can view dosage history on a study web-portal. Missed or double doses beyond a predefined threshold will trigger an email notification to a designated member of the oncology provider team, who will be prompted to contact the patient to address the issue to close the communication loop. If nonadherence is due to cost, providers will be trained to refer patients to the Patient Advocate Foundation, a national non-profit financial navigation program. EUC patients will have access to educational materials to improve side effect management. Patients will receive the interventions for 12 months and complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to: (1) compare CDK4/6i adherence; and (2) patient-reported outcomes (PROs) including symptom burden, quality of life, patient-provider communication, self-efficacy for managing symptoms, and financial worry at 12 months between CONCURxP and EUC arms; (3) use mixed methods to describe the patient and provider experience with the CONCURxP intervention; and (4) explore healthcare utilization, progression-free, and overall survival at 12 months in CONCURxP patients compared to EUC. The primary endpoint is adherence at 12 months, defined as the proportion of days patients took CDK4/6i according to the prescribed frequency, measured by pillbox. Our novel multilevel mHealth intervention will provide valuable and actionable results to improve health outcomes and patient experience.