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

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

• 批准号: 10681231
• 负责人: Ilana Graetz
• 金额: $ 58.23万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 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/10681231
• 关键词: Address; Adherence; Adult; Advocate; Age; CDK4 gene; Cellular Phone; Clinic Visits; Clinical; Communication; Community Clinical Oncology Program; Complex; Country; Data; Dependence; Dose; Educational Materials; Electronic Mail; Emergency department visit; Enrollment; Epidermal Growth Factor Receptor; Foundations; Frequencies; Goals; Health; Healthcare; Hospitalization; Human; Incidence; Inequity; 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; automated text message; 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; older women; participant enrollment; patient engagement; 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

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.

项目概要 细胞周期蛋白依赖性激酶 4/6 抑制剂 (CDK4/6i) 使无进展生存期几乎翻倍并增加 激素受体阳性 (HR+) 人类表皮细胞添加内分泌治疗后的总生存率 生长因子受体 2 阴性 (HER2-) 转移性乳腺癌 (MBC) 的发病率不断上升。 在年轻女性中，强调需要优化对复杂药物治疗方案的依从性，事实证明 CDK4/6 的复杂给药方案和高成本被认为有助于提高生存率。 关于 CDK4/6i 不依从性对生存、症状的影响的证据有限。 随着医疗保健转向更加依赖远程医疗，并且随着 提高短信移动电话在各阶层人口中的普及率，我们建议 测试创新的个性化多层次 mHealth 干预措施，通过进行 CONnected CUstomized Treatment Platform (CONCURxP) 与增强型治疗平台的随机对照试验 CONCURxP 试验将招募 390 名 HR+ 讲英语或西班牙语的成年女性。 HER2- MBC 和 CDK4/6i 的新处方，他们拥有带有短信功能的手机，并且 在参与的 NCI 社区肿瘤​​学研究计划 (NCORP) 实践之一中接受治疗。 为了客观地测量 CDK4/6i 的依从性，所有入组患者都将收到智能药盒。 除了常规护理外，患者还将：(1) 收到有关错过或额外剂量的自动文本提醒 由智能药盒发出信号；(2) 回复短信，说明每次 CDK4/6i 非故障事件的原因。 依从性；(3) 可以在研究门户网站上查看剂量历史记录。 预定义的阈值将触发向肿瘤提供者团队的指定成员发送电子邮件通知， 系统将提示谁联系患者以解决问题，从而关闭沟通循环。 不遵守是由于成本，提供者将接受培训，将患者转介给患者倡导基金会，该基金会是一个 国家非营利性金融导航计划。 EUC 患者将有机会获得教育材料 改善副作用管理。患者将接受为期 12 个月的干预措施，并于 2019 年完成调查。 基线、入组后 3、6 和 12 个月我们的目标是：(1) 比较 CDK4/6i 的依从性；(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、 CONCURxP 和 EUC 组之间 12 个月时管理症状的自我效能和财务担忧； (3) 使用混合方法来描述患者和提供者对 CONCURxP 干预的体验；以及 (4) 探索 CONCURxP 患者的医疗保健利用率、无进展生存期和 12 个月时的总生存期 与 EUC 相比，主要终点是 12 个月的依从性，定义为患者天数比例。 按照规定的频率服用 CDK4/6i，并通过 Pillbox 进行测量。 干预将提供有价值且可行的结果，以改善健康结果和患者体验。

项目成果

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study.

使用 CONnected CUstomized 治疗平台提高转移性​​乳腺癌女性患者的 Palbociclib 依从性：一项试点研究。

• DOI: 10.1177/10781552231161823
• 发表时间: 2023
• 期刊: Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
• 作者: Sadigh,Gelareh;Meisel,JaneL;Byers,Kristina;Robles,Andrew;Serrano,Leslie;Jung,OliviaS;Coleman,Debrua;Yeager,KatherineA;Graetz,Ilana
• 通讯作者: Graetz,Ilana