Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to improve participation of Hispanic children in cancer clinical trials

项目总结 在美国，儿童癌症是婴儿时期疾病死亡的主要原因，而存活率是 尽管情况有所改善，但明显的种族/民族差距依然存在。西班牙裔儿童的发病率明显更高 几种癌症，总体存活率低于非西班牙裔白人(NHW)。虽然 临床试验的登记与更高的存活率有关，NIH要求适当地将少数族裔纳入 临床试验，拉美裔癌症儿童在癌症临床试验中的代表性明显不足 到卫生福利院。鉴于到2030年拉美裔将占美国儿童人口的33%，迫切需要 需要确定有效的干预措施，以克服试验收益低的问题，使拉美裔人公平受益。新奇数据 来自我们小组的研究表明，研究素养不足(理解信息并对信息采取行动的能力) 做出研究决定)是参与临床试验的障碍。在知识方面有很大的差距 关于提高拉美裔儿童的研究素养和临床试验参与度的干预措施。这款R01是 在她的K08大奖《Comprendo》中，被PI开发的同伴导航干预所告知 (儿童恶性肿瘤同行研究导航)。Comprendo(改编自循证患者 导航模式)涉及受过培训的同龄人(父母)，他们提供文化、语言和健康素养- 在知情同意治疗期间对癌症儿童的父母/监护人进行协调教育 临床试验。在我们的试点可行性研究中，Comprendo是可行的，利益相关者高度接受， 提高父母知情同意的理解力和自愿性(参与研究的意愿 而不会感到压力)。合乎逻辑的下一步是在更大范围内测试公司效率。我们 将在4个地点进行多站点有效性实施随机临床试验(RCT)研究Comprendo 有不同的西班牙裔人口。我们的长期目标是实现可概括、有针对性、有效、 以及可重复的同行导航干预措施，以提高少数人对临床试验的收益。最重要的是 R01的目标是通过改进研究来增加西班牙裔癌症儿童的临床试验收益 父母在混合类型1设计中的识字能力，以测试综合效率和探索 多站点实施的决定因素。西班牙裔父母将随机接受全面护理或常规护理 [仅与肿瘤学家知情同意]。我们将衡量以儿童为中心(应计)和以父母为中心 (理解、自愿、决策后悔、决策自我效能和满意度)结果。 影响：这项研究意义重大，因为它解决了一个研究不足的领域，通过在以下方面产生了可操作的知识 同行导航如何提高研究素养。Comprendo是在利益相关者的参与下开发的 在多站点RCT中创新其定向对等导航和实施评估，以告知规模 向上。Comprendo有可能增加拉美裔美国人在整个年龄段的临床试验收益， 实现发现和治疗的公平转换，这是NCI的首要任务。

PROJECT SUMMARY Childhood cancer is the leading cause of death by disease past infancy in the U.S. While survival rates are improving, stark racial/ethnic disparities remain. Hispanic children have a significantly higher incidence of several cancers, and inferior overall survival than their non-Hispanic White (NHW) counterparts. Although clinical trial enrollment is linked to higher survival and NIH mandates appropriate inclusion of minorities in clinical trials, Hispanic children with cancer are significantly underrepresented in cancer clinical trials compared to NHWs. Given that Hispanics will comprise 33% of the U.S. childhood population by 2030, there is an urgent need to identify effective interventions to overcome low trial accrual to equitably benefit Hispanics. Novel data from our group suggest that inadequate research literacy (capacity to understand and act on information to make decisions about research) is a barrier to participation in clinical trials. There are major gaps in knowledge about interventions to improve research literacy and clinical trial participation for Hispanic children. This R01 is informed by the PI’s peer navigation intervention developed during her K08 award, “COMPRENDO” (ChildhOod Malignancy Peer REsearch NavigatiOn). COMPRENDO (adapted from the evidence-based patient navigation model) involves trained peers (parents) who deliver culture, language, and health literacy- concordant education to parents/guardians of children with cancer during informed consent for therapeutic clinical trials. In our pilot feasibility study, COMPRENDO was feasible, highly acceptable by stakeholders and increased parental informed consent comprehension and voluntariness (willingness to participate in research without feeling pressured). The logical next step is to test COMPRENDO effectiveness on a larger scale. We will study COMPRENDO in a multisite effectiveness-implementation randomized clinical trial (RCT) in 4 sites with diverse populations of Hispanics. Our long-term goal is to implement generalizable, targeted, effective, and reproducible peer navigation interventions to enhance minority accrual to clinical trials. The overarching objective of this R01 is to increase clinical trial accrual in Hispanic children with cancer by improving research literacy in their parents in a Hybrid Type 1 design to both test COMPRENDO effectiveness and explore multisite implementation determinants. Hispanic parents will be randomized to COMPRENDO or usual care [informed consent with the oncologist only]. We will measure child-centered (accrual) and parent-centered (comprehension, voluntariness, decisional regret, decision-making self-efficacy, and satisfaction) outcomes. Impact: This research is significant as it addresses an understudied area by yielding actionable knowledge on how peer navigation can improve research literacy. Developed with stakeholder input, COMPRENDO is innovative for its targeted peer navigation and its implementation evaluation in a multisite RCT to inform scale up. COMPRENDO has the potential to increase clinical trial accrual in Hispanics across the age continuum, enabling the equitable translation of discoveries and therapies, which is a top priority for NCI.