Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

项目摘要 癌症治疗的高额自付费用（OOPC）和收入损失导致经济困难。有 有令人信服的证据表明，OOPC沟通辅之以财务导航和咨询， 通过使癌症患者能够预期和适应治疗费用来减少经济困难， 积极寻求财政援助。重要的是，这种干预与医疗保险中心和 医疗补助服务（CMS）价格透明度要求。我们将评估一个创新的 个性化干预旨在通过开展一项旨在改善与成本相关的癌症护理不依从性的研究， OOP成本沟通和财务导航（CostCOM）与 NCI社区肿瘤学研究计划（NCORP）实践中的增强常规护理（EUC）。我们 一个多学科团队在拟议干预的各个方面都有经验，包括进行临床 在NCORP的实践中进行试验。CostCOM包括四个1小时的辅导课程，传授：（1）OOPC 使用价格估算工具对预期的OOPC进行沟通、个性化、患者特定的教育; (2)金融导航，实时专业指导，以确定金融援助计划， 减轻护理费用和讨论信息，以提高保险覆盖面;（3）财务咨询， 解决患者的经济问题，并将患者纳入经济援助计划。我们将 招募720例新诊断的实体瘤患者（1：1非转移性vs.转移性），计划接受 在参与的NCORP实践之一进行抗癌治疗。CostCOM手臂患者将参加四个 在基线、3个月、6个月和12个月时与远程财务顾问进行电话或视频会话， Costcom在每届会议上提供的组件。入组时，EUC组患者将接受常规治疗 通过提供描述服务和患者联系信息的教育手册来增强 倡导者基金会（PAF），一个全国性的非营利性金融导航组织。患者将完成 在基线、入组后3个月、6个月和12个月进行调查。我们的目标是（1）比较 12个月时CostCOM与EUC关于患者报告的成本相关癌症护理不依从性的比较，定义为任何 由于成本问题而延迟、放弃、停止或改变癌症护理的自我报告事件，以及（2） 患者报告的物质经济困难、经济担忧和生活质量;以及（3）进行一个过程 评估以检查实践提供者和CostCOM组患者对干预的满意度， 他们对CostCOM交付（对于提供者）或接收（对于患者）的障碍和促进因素的看法。一 成功的CostCOM是一个可扩展的和财务上可持续的计划，可以传播到 系统，条件和人群，并改善癌症护理服务，患者体验和健康 成果。

PROJECT SUMMARY High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance. Importantly, this intervention aligns with the Centers for Medicare and Medicaid Services (CMS) price transparency mandate. We will evaluate the effectiveness of an innovative personalized intervention designed to improve cost-related cancer care non-adherence by conducting a randomized controlled trial of OOP cost communication and financial navigation (CostCOM) vs. enhanced usual care (EUC) at NCI Community Oncology Research Program (NCORP) practices. Our multidisciplinary team has experience with all facets of the proposed intervention including conducting clinical trials at NCORP practices. CostCOM comprises four 1-hour counseling sessions to impart: (1) OOPC communication, individualized, patient-specific education of the anticipated OOPC using a price estimator tool; (2) Financial navigation, real-time professional guidance to identify financial assistance programs that will alleviate costs of care and discuss information to improve insurance coverage; and (3) Financial counseling to address the range of patients’ financial concerns and enroll patients in financial assistance programs. We will recruit 720 patients with newly diagnosed solid tumors (1:1 non-metastatic vs. metastatic) who plan to receive anticancer therapy at one of the participating NCORP practices. CostCOM arm patients will participate in four phone or video sessions with a remote financial counselor at baseline, 3, 6, and 12 months, with all three components of CostCOM delivered at each session. At enrollment, EUC arm patients will receive usual care enhanced by providing an educational brochure describing services and contact information of the Patient Advocate Foundation (PAF), a national non-profit financial navigation organization. Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to (1) compare the effectiveness of CostCOM vs. EUC at 12 months on patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns, as well as (2) patient-reported material financial hardship, financial worry, and quality of life; and (3) conduct a process evaluation to examine practice providers and CostCOM arm patients’ satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM delivery (for providers) or receipt (for patients). A successful CostCOM is a scalable and financially sustainable program that can be disseminated across systems, conditions, and populations and improve cancer care delivery, patients’ experience, and health outcomes.