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: 10206056
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10206056
• 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; Hispanics; 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; 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.

抽象的 儿童癌症是美国过去婴儿期儿童死亡的主要原因。而生存有 改善，主要是由于患者参与临床试验，仍然存在关键的种族/种族差异。比较的 对于非西班牙裔白人（NHW）儿童，西班牙裔人物的白血病发病率更高，存活率较差。 尽管西班牙裔将于2060年完成美国童年的33％，但他们的参与 生物医学研究非常低，如我们先前的工作中所示，西班牙裔人数不足 小儿癌研究。结果，结果数据主要是从NHW获得的。我们的初步数据， 以及其他人的研究，表明有足够的知情同意和较低的研究素养（能力 理解并采取信息以做出研究的决定）是少数群体参与的障碍 临床试验。提高研究素养和临床试验参与的干预措施，特别是对于西班牙裔， 缺乏。迫切需要在知识中填补这一空白，因为量身定制的干预措施是 实施科学可以提高研究素养和少数参与临床试验。目标 这项K08是通过适应性患有白血病儿童的父母的研究素养（来自患者 - 导航模型）和实施“ comprendo”（儿童恶性同伴研究导航）， 量身定制的同行流动干预（PNI）。我们的假设和理由是PNIS。 实施科学，训练有素的同龄人在文化和语言上进行一致的教育向 父母在知情同意书中可以识别和解决以下障碍：a）足够的研究素养，b） 公平的临床试验参与。通过增加少数人参与临床试验，我们可以有效地 翻译发现和治疗，并最终提高潜水人群中生存的平等，这是 NCI的重中之重。我们建议实施Comprendo，以提高儿科的父母研究素养 白血病临床试验，使用混合方法和实施科学（AIM 1）。我们将比较 Comprendo与常规护理在改善研究素养成果的有效性 白血病儿童（AIM 2）使用Hybrid试验1型有效性和实施设计。我们 假设，与通常的护理相比，父母随机分配给PNI将显示出更高的理解力， 自愿性，应计和较低的不信任后知情同意讨论，干预后4周。 该K08奖基于PI在生物伦理学和儿科癌症分布中的形成性工作，并在 PI在实施科学，干预适应，定性方法和 行为临床试验设计。该K08具有重要的影响：获得的知识可以推广到 整个生命周期中的西班牙裔人，将有助于：a）为临床护理提供信息，b）设计多站点随机分组 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R01中，使PI成为成功的身体科学家的独立过渡。