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: 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
• 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

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.

项目总结