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 儿童癌症是美国婴儿期过后儿童因疾病死亡的主要原因。 改善，主要是由于患者参与临床试验，但严重的种族/民族差异仍然存在。 对于非西班牙裔白人（NHW）儿童来说，西班牙裔的白血病发病率较高，生存率较差。 尽管到 2060 年，西班牙裔将占美国儿童人口的 33%，但他们对 生物医学研究极低，正如我们之前的工作所示，西班牙裔在生物医学研究中的代表性不足 因此，结果数据主要来自 NHW 的初步数据。 和其他人的研究表明，充分的知情同意和较低的研究素养（能力） 理解信息并根据信息采取行动以做出研究决策）是少数群体参与研究的障碍 提高研究素养和临床试验参与度的干预措施，特别是针对西班牙裔， 迫切需要填补这一知识空白，并采取针对性的干预措施。 实施科学可以提高研究素养和少数人对临床试验的参与。 K08 的目的是通过适应（从患者到患者）来提高白血病儿童父母的研究素养 导航模型）并实施“COMPRENDO”（ChildhOod 恶性肿瘤同行研究导航） 我们的假设和理由是，PNI 是由定制的同伴导航干预 (PNI) 指导的。 实施科学，其中受过训练的同伴向学生提供文化和语言一致的教育 家长在知情同意期间可以识别并解决以下方面的障碍：a) 足够的研究素养，b) 通过增加少数人参与临床试验，我们可以有效地参与临床试验。 转化发现和治疗方法，并最终提高不同人群的生存公平性，这是 我们建议实施 COMPRENDO 来提高家长的儿科研究素养。 白血病临床试验，使用混合方法和实施科学（目标 1）。 COMPRENDO 与常规护理在改善父母研究素养结果方面的有效性 我们使用混合试验 1 型的有效性和实施设计来治疗白血病儿童（目标 2）。 相比之下，与常规护理相比，随机分配到 PNI 的父母会表现出更高的理解力， 知情同意讨论后和干预后 4 周后的自愿性、权责发生制和较低的不信任度。 该 K08 奖项建立在 PI 在生物伦理学和儿科癌症差异方面的形成性工作的基础上，并映射了 PI 在实施科学、干预适应、定性方法和 行为临床试验设计具有重要影响：获得的知识可以推广到 西班牙裔人的整个生命周期，将有助于：a）为临床护理提供信息，b）设计多地点随机 临床试验，其中 COMPRENDO 将在更大的西班牙裔样本中进行测试，样本范围更广 未来 R01 中的癌症，使 PI 能够过渡为独立的成功医师科学家。