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

使用 CONnected CUstomized Treatment Platform (CONCURxP) 提高药物依从性

基本信息

批准号：
10443289
负责人：
Ilana Graetz
金额：
$ 67.86万
依托单位：
UNIVERSITY OF CALIFORNIA-IRVINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-10 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10443289
关键词：
Address Adherence Adult Advocate Age CDK4 gene Car Phone Cellular Phone Clinic Visits Clinical Communication Community Clinical Oncology Program Complex Country Data Dependence Dose ERBB2 gene Educational Materials Electronic Mail Emergency department visit Enrollment Epidermal Growth Factor Receptor Foundations Frequencies Goals Health Healthcare Hospitalization Human Incidence Intervention Interview Lead Measures Metastatic breast cancer Methods Monitor Notification Oncology Oral Outcome Participant Patient Care Patient Outcomes Assessments Patients Penetration Pharmaceutical Preparations Population Population Heterogeneity Progression-Free Survivals Provider Publishing Quality of life Race Randomized Controlled Trials Recording of previous events Regimen Reporting Research Schedule Self Efficacy Signal Transduction Surveys Symptoms System Technology Telemedicine Testing Text Text Messaging Time Training Underserved Population Visit Woman adherence rate adjuvant endocrine therapy arm base breast cancer diagnosis cancer therapy chemotherapy cost dosage experience health care service utilization healthcare community hormone receptor-positive hormone therapy improved individualized medicine inhibitor innovation mHealth malignant breast neoplasm medication compliance member novel patient-clinician communication primary endpoint programs recruit remote monitoring satisfaction side effect symptom management treatment as usual usability usual care arm web portal young woman

项目摘要

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.

项目摘要依赖细胞周期蛋白的激酶4/6抑制剂（CDK4/6i）几乎使无进展生存率增加并增加当在马酮受体阳性（HR+）中添加到内分泌疗法中时，总生存率，人表皮生长因子受体2阴性（HER2-）转移性乳腺癌（MBC）。 MBC的日益增长的事件在年轻妇女中，有必要优化对复杂药物方案的依从性增加存活率。 CDK4/6IS的复杂给药时间表以及高成本被认为有助于不遵守。关于CDK4/6i不遵守对生存，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，以及在人群的每个部分中，启用文本手机的渗透率都会增加，我们建议测试创新的个性化多级MHealth干预措施，以通过进行一次连接的定制治疗平台（ConcurXP）的随机对照试验与增强通常的护理（EUC）。 ConcurXP试验将招募390个英语或西班牙语 - 患有人力资源+的成年女性 HER2- MBC和CDK4/6i的新处方在参与的NCI社区肿瘤研究计划（NCORP）实践中接受治疗。到客观测量的CDK4/6i依从性，所有注册的患者都将获得智能药盒。 concurxp臂除了通常的护理外，患者还将：（1）接收自动化的文本提醒由智能药盒发出信号；（2）响应文本消息，引用CDK4/6i的每次事件的原因依从性；（3）可以在研究网站上查看剂量史。错过或双剂量超出了预定义的阈值将触发肿瘤提供商团队指定成员的电子邮件通知，将提示谁与患者联系以解决问题以关闭通信循环。如果不依从性是由于成本造成的，提供者将接受培训，将患者推荐给患者倡导者基金会，一个国家非营利金融导航计划。 EUC患者将可以使用教育材料改善副作用管理。患者将接受12个月的干预措施，并在招生后的基线3、6和12个月。我们的目标是：（1）比较CDK4/6i依从性；（2）患者报告的结果（专业）包括符号伯恩，生活质量，患者提供沟通，管理符号的自我效能感，以及在ConcurXP和EUC武器之间12个月的财务忧虑；（3）使用混合方法来描述患者和提供者的经验以及ConcurXP干预；和（4）探索ConcurXP患者12个月时12个月的医疗保健利用，无进展和总生存与EUC相比。主要终点是在12个月的依从性，定义为患者的比例按照药丸盒测量的规定频率取下CDK4/6i。我们的小说多级MHealth 干预将提供有价值且可行动的结果，以改善健康成果和患者经验。