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: 10921490
• 负责人: Paula Aristizabal
• 金额: $ 14.86万
• 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/10921490
• 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; Equity; Ethnic Origin; Feedback; Future; Goals; Hispanic; Hispanic Populations; Hybrids; Incidence; Inequity; 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; Pediatric Oncologist; Physicians; Population; Population Heterogeneity; Provider; Qualitative Methods; Randomized; Research; Sampling; Scientist; Site; Survival Rate; Testing; Training; Translating; Work; acceptability and feasibility; anticancer research; behavioral clinical trial; cancer health disparity; cancer therapy; clinical care; compare effectiveness; cost; design; effectiveness/implementation design; ethnic disparity; hybrid type 1 trial; implementation intervention; implementation science; improved; infancy; leukemia; literacy; patient navigation; peer; pilot test; post intervention; primary outcome; racial disparity; randomized, clinical trials; 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

项目成果

Disparities in Pediatric Oncology: The 21st Century Opportunity to Improve Outcomes for Children and Adolescents With Cancer.

• DOI: 10.1200/edbk_320499
• 发表时间: 2021-06
• 期刊: American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

The Golden Hour: Sustainability and Clinical Outcomes of Adequate Time to Antibiotic Administration in Children with Cancer and Febrile Neutropenia in Northwestern Mexico.

• DOI: 10.1200/go.20.00578
• 发表时间: 2021-05
• 期刊: JCO global oncology
• 影响因子: 4.5
• 作者: Gonzalez ML;Aristizabal P;Loera-Reyna A;Torres D;Ornelas-Sánchez M;Nuño-Vázquez L;Aguilera M;Sánchez A;Romano M;Rivera-Gómez R;Relyea G;Friedrich P;Caniza MA
• 通讯作者: Caniza MA

Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials.

• DOI: 10.1001/jamanetworkopen.2021.9038
• 发表时间: 2021-05-03
• 期刊: JAMA network open
• 影响因子: 13.8
• 作者: Aristizabal P;Ma AK;Kumar NV;Perdomo BP;Thornburg CD;Martinez ME;Nodora J
• 通讯作者: Nodora J

Improving Pediatric Neuro-Oncology Survival Disparities in the United States-Mexico Border Region: A Cross-Border Initiative Between San Diego, California, and Tijuana, Mexico.

• DOI: 10.1200/go.20.00377
• 发表时间: 2020-11
• 期刊: JCO global oncology
• 影响因子: 4.5
• 作者: Aristizabal P;Burns LP;Kumar NV;Perdomo BP;Rivera-Gomez R;Ornelas MA;Gonda D;Malicki D;Thornburg CD;Roberts W;Levy ML;Crawford JR
• 通讯作者: Crawford JR

Diverse populations and enrollment in pediatric cancer clinical trials: Challenges and opportunities.

• DOI: 10.1002/pbc.28296
• 发表时间: 2020-11
• 期刊: Pediatric blood & cancer
• 影响因子: 3.2
• 作者: Aristizabal P