Novel Health Equity Intervention to Improve Pediatric Oncology Outcome Disparities: Targeting Poverty and Psychosocial Stress

Objectives: The objective of this study is to investigate the efficacy of a novel Health Equity Intervention (HEI) for parents of children with high-risk neuroblastoma that provides both concrete and resilience resources to reduce poverty-associated outcome disparities. Specifically, we aim to identify HEI efficacy in improving parent-centered outcomes of anxiety, depression and cognitive function; and explore the impact of the HEI on child-centered outcomes of end-induction disease response, event-free survival and overall survival, and biomarkers of stress. The proposed HEI will be embedded in the upcoming Children’s Oncology Group (COG) chemoimmunotherapy trial for children with high-risk neuroblastoma. Project tasks: Northwestern will participate in the above-named project as a subcontracted site, to support Dr. Miller’s role on the project as a co-investigator with expertise in stress biology and evaluation of biomarkers indicative of stress exposures. For this project, Dr. Miller will be responsible for the interpretation of biomarkers of oxidative stress and inflammation and will collaborate with the MPIs to complete all planned analyses. As a Co-Investigator, Dr. Miller will collaborate with Drs. Bona and Rosenberg to interpret biospecimen data and their associations with the HEI. Our site will contribute fully to the aims outlined in the grant application and summarized above. This includes providing expertise regarding biospecimen analysis and interpretation; participating in cross-site training and regular conference calls; any video-conferencing or in person meetings; analyzing data; and contributing to the dissemination of findings. Throughout the duration of the project (Years 1-5), Gregory Miller, PhD (Co-Investigator) will provide the following: YEARS 1-5: Overall Study Conduct • Work closely with Drs. Bona and Rosenberg to oversee conduct of this multi-center study Task 1: Protocol • Contribute to protocol development within COG and human subjects approval with the Pediatric Central IRB o Participate in preparation and submission of protocol amendments as needed with a focus on proposed biomarkers of stress o Participate in continuing reviews and other regulatory requirements as needed o Finalize preparation of ancillary study Support Guide for dissemination to COG sites with a focus on biosample collection, preparation and shipping Task 2: Participant evaluation • Participate in finalizing processes for biosample measurements at each study visit • Participate in regular conference calls to discuss study recruitment and adherence to biospecimen data collection Task 3: Data analyses and dissemination • Participate in data analysis, analysis of study outcomes, manuscript drafting and revisions and dissemination of study findings