CAFÃÂÃÂ: clinic-based intervention to address financial hardship for people with cancer

项目总结 癌症带来的经济困难在癌症患者中很普遍，并与几个不利因素有关 中期和健康结果，包括生活质量、治疗依从性和存活率。沟通 关于自掏腰包的费用在治疗轨迹的早期可能有助于防止或减轻经济困难。 CAF？是一项采用阶梯楔形设计的随机试验，用于测试新的CAF？(癌症财务体验) 干预。干预是基于研究团队之前的研究，得到了一个概念性的 以患者为中心的沟通如何改善健康的框架，并与临床团队一起设计 会员和患者采用以人为本的设计方法。我们的目标是： 目标1：比较自我报告的经济困难以及接受CAFé干预的患者与 对照组随访12个月。 目标1a：比较接受CAFé治疗的患者自我报告的健康相关生活质量 干预组与对照组进行12个月的随访。 目标2：比较接受CAFé干预的患者之间的卫生服务利用情况 两组均于12个月随访。 目的3：评估影响CAFé干预剂量变异性的患者水平因素。 新诊断的癌症患者(n=750)将随机接受(A)资源表列表 财政支助资源或(B)基于财务导航器的干预，将包括6个月的 与费用有关的个性化外联和援助，包括与肿瘤科团队的协调， 提供自付费用估算，以支持共享的临床决策、患者规划和 编制预算，并根据需要转介财政援助资源。两个综合健康中心的肿瘤科诊所 太平洋西北地区的系统(Kaiser Permanente Washington和Kaiser Permanente西北)将是 研究的背景。我们感兴趣的主要结果是12个月后的财务困境。次要的 结果包括与健康相关的生活质量，癌症造成的经济困难，患者评估 沟通经验，以及开始治疗的时间。 CAFé研究是以减轻患者经济状况为重点的干预措施的首批试验之一 困难重重。它以理论为基础，以临床为基础，与患者的偏好保持一致，并已被开发出来 在广泛的利益相关者投入之后。通过设计，它将提供高质量的关于 医疗费用沟通对患者相关癌症预后的潜在好处。

PROJECT SUMMARY Financial hardship from cancer is prevalent among people with cancer and related to several adverse intermediate and health outcomes, including quality of life, treatment adherence, and survival. Communication about out of pocket costs early in the treatment trajectory could help to prevent or lessen financial hardship. CAFÉ is a randomized trial with step wedge design to test the novel CAFÉ (Cancer Financial Experience) intervention. The intervention is based on the research team's prior studies, informed by a conceptual framework of how patient-centered communication can improve health, and designed with clinic team members and patients using human-centered design methods. Our aims are: Aim 1: Compare self-reported financial hardship and between patients receiving the CAFÉ intervention versus a comparison group at 12-month follow up. Aim 1a: Compare self-reported health-related quality of life between patients receiving the CAFÉ intervention versus a comparison group at 12-month follow up. Aim 2: Compare health service use between patients receiving the CAFÉ intervention versus a comparison group at 12-month follow up. Aim 3: Assess patient-level factors influencing variability in dose of the CAFÉ intervention. Newly diagnosed cancer patients (n=750) will be randomized to receive either (a) a resource sheet listing financial support resources or (b) a financial navigator-based intervention that will include 6 months of personalized outreach and assistance with cost concerns, including coordination with the oncology team, provision of out of pocket cost estimates to support shared clinical decision-making, patient planning and budgeting, and referral to financial assistance resources as needed. Oncology clinics in two integrated health systems in the Pacific Northwest (Kaiser Permanente Washington and Kaiser Permanente Northwest) will be the setting for the study. Our primary outcome of interest is financial distress at 12-month follow-up. Secondary outcomes include health-related quality of life, financial hardship due to cancer, patient assessment of communication experiences, and time to initiation of treatment. The CAFÉ study represents one of the first trials of an intervention focused on mitigating patient financial hardship. It is theory-informed and clinic-based, aligned with patient preferences, and has been developed following extensive stakeholder input. By design, it will provide high quality prospective evidence on the potential benefits of cost of care communication on patient-relevant cancer outcomes.