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.

项目概要 儿童癌症是美国婴儿期以上疾病死亡的主要原因。 尽管有所改善，但拉美裔儿童的种族/民族差异仍然明显较高。 与非西班牙裔白人 (NHW) 省份相比，其总生存率较低。 临床试验注册与较高的生存率相关，NIH 要求适当地将少数群体纳入其中 临床试验中，与癌症临床试验相比，西班牙裔癌症儿童的代表性明显不足 鉴于到 2030 年，西班牙裔将占美国儿童人口的 33%，因此迫切需要解决这一问题。 需要确定有效的干预措施来克服试验应计率低的问题，以公平地使西班牙裔数据受益。 我们小组的研究表明，研究素养（理解信息并根据信息采取行动的能力）不足 做出有关研究的决定）是参与临床试验的障碍 知识方面存在重大差距。 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。 受益于 PI 在 K08 获奖期间开发的同伴导航干预措施“COMPRENDO” （儿童恶性肿瘤同行研究导航）（改编自基于证据的患者）。 导航模型）涉及受过训练的同伴（父母），他们提供文化、语言和健康素养 - 在治疗知情同意期间对癌症儿童的父母/监护人进行一致的教育 在我们的试点可行性研究中，COMPRENDO 是可行的，受到利益相关者和高度认可。 增加父母知情同意的理解和自愿性（参与研究的意愿 没有感到压力）下一步是在更大范围内测试 COMPRENDO 的有效性。 将在 4 个地点的多中心有效性实施随机临床试验 (RCT) 中研究 COMPRENDO 我们的长期目标是实施普遍的、有针对性的、有效的、 以及可重复的同行导航干预措施，以提高少数群体对临床试验的贡献。 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数量 采用混合 1 型设计来测试 COMPRENDO 有效性并探索父母的读写能力 多地点实施决定因素。西班牙裔家长将被随机分配到 COMPRENDO 或常规护理。 [仅获得肿瘤科医生的知情同意]我们将衡量以儿童为中心（权责发生制）和以家长为中心的情况。 （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，因为它通过提供可操作的知识来解决尚未研究的领域 COMPRENDO 是根据利益相关者的意见而开发的。 创新性的有针对性的同行导航及其在多站点随机对照试验中的实施评估，以告知规模 COMPRENDO 有潜力增加西班牙裔各个年龄段的临床试验累积量， 实现发现和疗法的公平转化，这是 NCI 的首要任务。