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 在美国，儿童癌症是婴儿期后疾病死亡的主要原因。 尽管情况有所改善，但种族/族裔之间的差距仍然很大。西班牙裔儿童的发病率明显较高， 与非西班牙裔白色（NHW）的同类相比，虽然 临床试验招募与更高的生存率有关，NIH要求适当纳入少数民族， 西班牙裔癌症儿童在癌症临床试验中的代表性明显不足， 到NHWS。鉴于到2030年西班牙裔将占美国儿童人口的33%，因此迫切需要 需要确定有效的干预措施，以克服低试验应计率，公平地使西班牙裔受益。新颖的数据 研究素养不足（理解信息并根据信息采取行动的能力， 对研究作出决定）是参与临床试验的障碍。在知识上存在重大差距 关于提高西班牙裔儿童的研究素养和临床试验参与的干预措施。这款R 01是 通过PI在K 08奖期间开发的同行导航干预，“COMPRENDO” （ChildhOod ChildhOod Peer Research NavigatiOn）. 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， 增加父母知情同意的理解和自愿性（参与研究的意愿 没有压力）。合乎逻辑的下一步是在更大范围内测试COMPRENDO的有效性。我们 将在4个研究中心进行的多中心有效性实施随机临床试验（RCT）中研究COMPRENDO 有着不同的西班牙裔人口我们的长期目标是实施可推广的、有针对性的、有效的， 和可重复的同行导航干预，以提高少数应计临床试验。总体 本R 01的目的是通过改善研究，增加西班牙裔癌症儿童的临床试验收益 在混合1型设计中，父母的识字能力，以测试COMPRENDO的有效性，并探索 多站点实施决定因素。西班牙裔父母将随机接受COMPRENDO或常规护理 [仅肿瘤科医生知情同意]。我们将衡量以儿童为中心（应计）和以父母为中心 （理解，非自愿性，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，因为它通过产生可操作的知识来解决一个研究不足的领域， 同行导航如何提高研究素养。在利益相关者的投入下开发，COMPRENDO是 创新性在于其有针对性的同行导航及其在多站点RCT中的实施评估，以告知规模 起来COMPRENDO有可能增加整个年龄段西班牙裔的临床试验累积， 使发现和疗法的公平转化成为可能，这是NCI的首要任务。