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

多站点实施 COMPRENDO（儿童恶性肿瘤同行研究导航）以提高西班牙裔儿童对癌症临床试验的参与

• 批准号: 10639968
• 负责人: Paula Aristizabal
• 金额: $ 69.27万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-26 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10639968
• 关键词: Address; Administrator; Age; Alabama; Area; Award; California; Cause of Death; Child; Childhood; Clinical; Clinical Trials; Collaborations; Comprehension; Data; Decision Making; Disease; Education; Effectiveness; Equity; Ethics; Exploration, Preparation, Implementation, and Sustainment; Feasibility Studies; Feeling; Future; Goals; Hispanic; Hispanic Populations; Hybrids; Incidence; Inferior; Informed Consent; Intervention; Knowledge; Language; Link; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Methodology; Methods; Minority; Modeling; Newly Diagnosed; Not Hispanic or Latino; Oncologist; Oncology; Outcome; Parents; Population; Population Heterogeneity; Proctor framework; Provider; Randomized; Regrets; Reporting; Reproducibility; Research; Sampling; San Francisco; Self Efficacy; Site; Survival Rate; Testing; Therapeutic Clinical Trial; Time; Training; Translations; United States National Institutes of Health; Universities; cancer clinical trial; cancer diagnosis; care delivery; clinical trial enrollment; disparity reduction; effective intervention; effectiveness testing; effectiveness/implementation hybrid; ethnic disparity; evidence base; health disparity; health literacy; hybrid type 1 design; implementation determinants; implementation evaluation; implementation outcomes; implementation science; implementation/effectiveness; improved; infancy; innovation; literacy; novel; patient navigation; peer; pressure; racial disparity; randomized, clinical trials; satisfaction; scale up; treatment as usual; trial comparing; willingness

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.

项目摘要 儿童癌症是美国过去婴儿期死亡的主要原因，而生存率为 改善，鲜明的种族/种族差异仍然存在。西班牙裔孩子的事件明显更高 虽然比非西班牙裔白人（NHW）对应物多种癌症，并且总体生存率较低。 临床试验入学率与较高的生存率有关，NIH要求将少数民族纳入适当 临床试验，在癌症临床试验中，西班牙裔儿童的癌症比例明显不足 到NHWS。鉴于西班牙裔将于2030年完成美国童年的33％ 需要确定有效的干预措施以克服低试验的准确性，以同样受益于西班牙裔。新数据 我们小组提出的研究素养不足（了解和采取信息的能力 对研究做出决定）是参与临床试验的障碍。知识有重大差距 关于改善西班牙裔儿童的研究素养和临床试验参与的干预措施。这个R01是 由PI在其K08奖“ Comprendo”期间开发的PI同行导航干预措施所告知 （儿童恶性同伴研究导航）。 Comprendo（根据循证患者改编 导航模型）涉及训练有素的同龄人（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/监护人的一致教育 临床试验。在我们的飞行员可行性研究中，Comprendo是可行的，利益相关者和 父母知情的同意理解和自愿性增加（愿意参加研究的意愿 没有压力）。逻辑下一步是在更大范围内测试Comprendo的有效性。我们 将在4个地点的多站点有效性随机临床试验（RCT）中研究Comprendo 有潜水员的西班牙裔人群。我们的长期目标是实施可推广，有针对性的，有效的， 以及可再现的同行导航干预措施，以提高临床试验的少数群体准确性。总体 R01的目的是通过改善研究来提高西班牙裔儿童的临床试验准确性 在混合1型设计中，父母的识字能够测试Comprendo的有效性和探索 多站点实施确定。西班牙裔父母将被随机分配给comprendo或通常的照顾 [仅与肿瘤学家的知情同意]。我们将衡量以儿童为中心（应计）和以父母为中心 （理解，自愿性，决策遗憾，决策自我效能感和满意度）的结果。 影响：这项研究很重要，因为它通过对可行的知识来解决知识的领域。 同行导航如何提高研究素养。由利益相关者输入开发，Comprendo IS 具有针对性的同行导航及其在多站点RCT中的实施评估的创新性 向上。 Comprendo有可能提高整个年龄连续性西班牙裔的临床试验准确性， 实现了发现和疗法的公平翻译，这是NCI的重中之重。