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.

项目摘要 细胞周期蛋白依赖性激酶4/6抑制剂（CDK 4/6 i）几乎使无进展生存期增加一倍， 在激素受体阳性（HR+）、人表皮生长因子受体阳性（HR+）、 生长因子受体2阴性（HER 2-）转移性乳腺癌（MBC）。MBC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， 提高生存率。CDK 4/6的复杂给药方案沿着高成本被认为有助于 不遵守。关于CDK 4/6 i不依从性对生存率、症状和预后影响的证据有限。 生活负担或生活质量。随着医疗保健过渡到更大程度地依赖远程医疗， 随着支持文本功能的移动的电话在人口各个部分的渗透率不断提高，我们建议 测试创新的个性化多层次mHealth干预，以提高CDK 4/6 i的依从性， 比较连接型定制化治疗平台（CONCURxP）与增强型定制化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女性， HER 2- MBC和CDK 4/6 i的新处方，他们有一个带短信的移动的电话， 在参与NCI社区肿瘤学研究计划（NCORP）的实践中接受治疗。到 为了客观地测量CDK 4/6 i依从性，所有入组的患者将接受智能药盒。CONCURxP组 除了常规护理之外，患者将：（1）接收自动文本提醒，以提醒错过的或额外的剂量， 由智能药盒发出信号;（2）响应短信，说明每次CDK 4/6 i非 依从性;和（3）可以在研究门户网站上查看剂量历史。漏服或加倍剂量超过 预定义的阈值将触发对肿瘤学提供者团队的指定成员的电子邮件通知， 将提示患者联系患者以解决问题，从而关闭通信回路。如果 不遵守是由于成本，提供者将接受培训，将病人转介给病人倡导基金会， 国家非营利金融导航计划。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，并在 基线、入组后3个月、6个月和12个月。我们的目标是：（1）比较CDK 4/6 i依从性;以及（2） 患者报告结局（PRO），包括症状负担、生活质量、患者-提供者沟通， CONCURxP组和EUC组12个月时症状管理的自我效能和财务担忧; (3)使用混合方法描述患者和提供者对CONCURxP干预的体验;以及 (4)探索CONCURxP患者12个月时的医疗保健利用、无进展和总生存期 与EUC相比。主要终点是12个月时的依从性，定义为患者的天数比例 按规定频率服用CDK 4/6 i，用药盒测量。我们的新型多层次mHealth 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。

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