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

项目摘要 癌症带来的经济困难在癌症患者中很普遍，与几个不利因素有关。 中间和健康结果，包括生活质量，治疗依从性和生存率。通信 在治疗过程的早期，关于自付费用的建议可能有助于预防或减轻经济困难。 CAFestival是一项采用阶梯楔形设计的随机试验，旨在测试新型CAFestival（癌症财务体验） 干预干预是基于研究小组以前的研究，由一个概念性的 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 使用以人为本的设计方法的成员和患者。我们的目标是： 目的1：比较接受CAF4干预的患者自我报告的经济困难与 12个月随访时的对照组。 目的1a：比较接受CAF治疗的患者自我报告的健康相关生活质量 在12个月随访时，干预组与对照组相比。 目的2：比较接受CAFAF干预的患者与对照患者之间的卫生服务使用情况 12个月随访。 目的3：评估影响CAF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 财政支持资源或（B）基于财务导航的干预措施，包括6个月的 个性化的外展和成本问题的援助，包括与肿瘤团队的协调， 提供自付成本估算，以支持共享的临床决策、患者规划和 预算编制，并根据需要转介财政援助资源。两个综合健康中心的肿瘤诊所 太平洋西北部的系统（凯撒永久华盛顿和凯撒永久西北）将 研究的背景。我们关注的主要结果是12个月随访时的财务困境。二次 结果包括与健康相关的生活质量，由于癌症造成的经济困难， 沟通经验和开始治疗的时间。 CAFRENT的研究代表了第一批旨在减轻患者经济负担的干预试验之一。 艰苦创业它以理论为基础，以临床为基础，与患者偏好保持一致，并已开发 在广泛的利益相关者投入之后。通过设计，它将提供关于 护理成本沟通对患者相关癌症结局的潜在益处。

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.