The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship.
The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship.
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DOI：
10.1186/s13063-022-06344-3
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发表时间：
2022-05-13
期刊：
影响因子：
2.5
通讯作者：
Banegas, Matthew P.
中科院分区：
文献类型：
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作者：
Henrikson, Nora B.;Anderson, Melissa L.;Dickerson, John;Ewing, John J.;Garcia, Robin;Keast, Erin;King, Deborah A.;Lewis, Cara;Locher, Blake;McMullen, Carmit;Norris, Consuelo M.;Petrik, Amanda F.;Ramaprasan, Arvind;Rivelli, Jennifer S.;Schneider, Jennifer L.;Shulman, Lisa;Tuzzio, Leah;Banegas, Matthew P.
迫切需要证据来证明干预措施如何预防或减轻与癌症相关的经济困难。我们的目标是在12个月随访时比较接受金融导航干预的患者与对照组之间自我报告的经济困难，生活质量和卫生服务使用情况，并评估与接受金融导航干预剂量相关的患者水平因素。癌症财务经验（CAFRENT）研究是一项多中心随机对照试验（RCT），具有个体水平的随机化。参与者将获得简短（一个金融导航周期，组2）或扩展（三个金融导航周期，组3）的金融导航。第2组和第3组的干预期均为6个月。对照组（第1组）将接受强化常规护理。该研究的背景是太平洋西北部两个综合卫生系统的医学肿瘤学和放射肿瘤学诊所。入选标准包括18岁或以上，最近诊断为癌症，并通过管理数据确定到研究诊所就诊。将在12个月随访时评估结局。主要结果是自我报告的财务困境和健康相关的生活质量。次要结果是延迟或放弃护理;接受医疗财政援助;和账户拖欠。混合方法探索性分析将调查与接受的总干预剂量相关的因素。CAFIGHTING研究将提供急需的早期试验证据，证明财务导航在减少癌症相关财务困难方面的影响。它以理论为基础，以临床为基础，与患者偏好保持一致，并在初步定性研究和利益相关者输入后开发。通过设计，它将提供关于财务导航对患者相关癌症结局的潜在益处的前瞻性证据。CAFÉ试验的优势包括其广泛的入选标准、以公平为中心的抽样计划、与临床和运营利益相关者合作开发的新型干预措施，以及与提供的干预剂量和接受的剂量相关的混合方法二次分析。由此产生的分析数据集将允许进行丰富的混合方法分析，并提供与实施干预措施有关的关键信息，如果它被证明是有效的。ClinicalTrials.gov NCT 05018000。2021年8月23日。
There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention. The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received. The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial’s strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective. ClinicalTrials.gov NCT05018000. August 23, 2021.
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