COMPRENDO: Adaptation and Implementation of a Peer-Navigation Intervention to Improve Research Literacy and Diversity in Pediatric Leukemia Clinical Trials

COMPRENDO：采用同行导航干预措施来提高小儿白血病临床试验的研究素养和多样性

• 批准号: 10460424
• 负责人: Paula Aristizabal
• 金额: $ 25.48万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-17 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10460424
• 关键词: Address; Administrator; Atlas of Cancer Mortality in the United States; Award; Bioethics; Biomedical Research; Cessation of life; Child; Childhood; Childhood Leukemia; Clinical Trials; Clinical Trials Design; Comprehension; Consolidated Framework for Implementation Research; Data; Decision Making; Disease; Dissemination and Implementation; Education; Effectiveness; Ethnic Origin; Feedback; Future; Goals; Hispanic; Hispanic Populations; Hybrids; Incidence; Informed Consent; Institute of Medicine (U.S.); Intervention; Knowledge; Limited English Proficiency; Linguistics; Longevity; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Methods; Minority Participation; Modeling; Newly Diagnosed; Not Hispanic or Latino; Outcome; Parents; Patient Participation; Patients; Pediatric Oncologist; Physicians; Population; Population Heterogeneity; Provider; Qualitative Methods; Randomized; Randomized Clinical Trials; Research; Sampling; Scientist; Site; Survival Rate; Testing; Training; Translating; Work; acceptability and feasibility; anticancer research; base; behavioral clinical trial; cancer health disparity; cancer therapy; clinical care; compare effectiveness; cost; design; effectiveness implementation design; hybrid type 1 trial; implementation intervention; implementation science; improved; infancy; leukemia; literacy; peer; pilot test; post intervention; primary outcome; racial and ethnic disparities; recruit; satisfaction; secondary outcome; survival disparity; treatment as usual

ABSTRACT Childhood cancer is the leading cause of child death by disease past infancy in the US. While survival has improved, mainly due to patient participation in clinical trials, critical racial/ethnic disparities remain. Compared to non-Hispanic White (NHW) children, Hispanics have higher incidence of leukemia and poorer survival rates. Although Hispanics will comprise 33% of the U.S. childhood population by 2060, their participation in biomedical research is critically low and, as shown in our prior work, Hispanics are underrepresented in pediatric cancer research. As a result, outcomes data are obtained mostly from NHW. Our preliminary data, and research from others, suggest that adequate informed consent and low research literacy (capacity to understand and act on information to make decisions about research) are barriers to minority participation in clinical trials. Interventions to improve research literacy and clinical trial participation, particularly for Hispanics, are lacking. There is an urgent need to fill this gap in knowledge, as tailored interventions guided by implementation science can improve research literacy and minority participation in clinical trials. The objective of this K08 is to improve research literacy in parents of children with leukemia by adapting (from the patient- navigation model) and implementing “COMPRENDO” (ChildhOod Malignancy Peer REsearch NavigatiOn), a tailored peer-navigation intervention (PNI). Our hypothesis and rationale are that PNIs guided by implementation science, in which trained peers deliver culturally and linguistically concordant education to parents during informed consent, can identify and address barriers to: a) adequate research literacy, and b) equitable clinical trial participation. By increasing minority participation in clinical trials, we can effectively translate discoveries and treatments, and, ultimately, improve equity of survival in diverse populations, which is a top priority for NCI. We propose to implement COMPRENDO to improve parental research literacy in pediatric leukemia clinical trials, using mixed-methods and implementation science (Aim 1). We will compare the effectiveness of COMPRENDO vs. usual care in improving research literacy outcomes among parents of children with leukemia (Aim 2) using a Hybrid Trial Type 1 effectiveness and implementation design. We hypothesize that, compared to usual care, parents randomized to the PNI will show higher comprehension, voluntariness, and accrual and lower mistrust post informed consent discussion and 4 weeks post intervention. This K08 award builds on the formative work of the PI in bioethics and pediatric cancer disparities and maps on to the PI’s training goals in implementation science, intervention adaptation, qualitative methods, and behavioral clinical trial design. This K08 has an important impact: knowledge gained can be generalized to Hispanics across the lifespan and will help to: a) inform clinical care, and b) design a multi-site randomized clinical trial, in which COMPRENDO will be tested in a larger sample of Hispanics with a broader range of cancers in a future R01, enabling the PI’s transition to independence as a successful physician-scientist.

摘要 在美国，儿童癌症是婴儿期后儿童死亡的主要原因。虽然生存 尽管主要由于患者参与临床试验而有所改善，但仍然存在严重的种族/民族差异。相比 与非西班牙裔白色（NHW）儿童相比，西班牙裔儿童的白血病发病率更高，存活率更低。 尽管到2060年，拉美裔将占美国儿童人口的33%，但他们的参与率仍将上升。 生物医学研究是非常低的，正如我们以前的工作所示，西班牙裔在 儿科癌症研究因此，结果数据主要来自NHW。我们的初步数据， 和其他人的研究表明，充分的知情同意和低研究素养（ 了解信息并根据信息作出研究决定）是少数群体参与研究的障碍， 临床试验干预措施，以提高研究素养和临床试验的参与，特别是对西班牙裔， 缺乏。迫切需要填补这一知识空白，因为在以下指导下采取有针对性的干预措施： 实施科学可以提高研究素养和少数人参与临床试验。客观 该K 08的目的是通过适应（从患者- 导航模型）和实现“COMPRENDO”（儿童语言对等搜索导航）， 定制同伴导航干预（PNI）。我们的假设和基本原理是， 实施科学，其中受过培训的同行提供文化和语言一致的教育， 在知情同意过程中，家长可以识别和解决障碍：a）充分的研究素养，以及B） 公平参与临床试验。通过增加少数群体对临床试验的参与，我们可以有效地 转化发现和治疗，并最终提高不同人群的生存公平性， 国家癌症研究所的首要任务我们建议实施COMPRENDO，以提高父母在儿科研究方面的素养。 白血病临床试验，使用混合方法和实施科学（目标1）。我们将比较 COMPRENDO与常规护理在改善儿童父母研究素养结果方面的有效性 儿童白血病（目标2）使用混合试验类型1的有效性和实施设计。我们 假设，与常规护理相比，随机分配到PNI的父母将表现出更高的理解力， 在知情同意讨论后和干预后4周，非自愿性和应计性以及较低的不信任。 这个K 08奖建立在PI在生物伦理学和儿科癌症差异方面的形成工作的基础上， PI在实施科学，干预适应，定性方法， 行为临床试验设计K 08具有重要的影响：获得的知识可以推广到 将有助于：a）告知临床护理，和B）设计多中心随机 临床试验，其中COMPRENDO将在更大的西班牙裔样本中进行测试， 癌症在未来的R 01，使PI的过渡到独立作为一个成功的医生，科学家。