Friday, May 9, 2025
5/9/2025
Diversifying Acute Leukemia Clinical Trial Enrollment Through Multilevel Intervention - PROJECT SUMMARY/ABSTRACT Race-ethnic disparities in cancer clinical trial enrollment bias research findings, limit generalizability, and reduce equitable access to the novel therapies and high-quality care that trials provide. Acute myeloid and lymphoblastic leukemia are aggressive but curable blood cancers that affect 170,000 persons nationally, and incidence-adjusted trial enrollment of Black and Hispanic adults with these cancers is among the lowest known—up to 85% less than White patients. These leukemias have a distinct care pattern that limits the utility of existing, community-based enrollment diversity interventions: patients require rapid inpatient therapy and up to half are seen at quaternary referral centers, where a significant proportion of disparate enrollment occurs. Modifiable elements of trial design, low provider empowerment, and patient hesitancy behaviors appear to play key roles in perpetuating this disparity. Recent policy and data science innovations now allow cancer registry and electronic health record data integration for enrollment diversity monitoring and intervention development. The goal of this proposal is to leverage these advances, developing three complementary projects that together comprise a multilevel intervention for overcoming barriers to diverse enrollment in acute leukemia. In Aim 1, a preemptive trial protocol review system will be developed to identify acute leukemia trial design elements associated with enrollment disparities using a predictive risk score and community assessment. In Aim 2, an enrollment diversity performance feedback interface for acute leukemia providers will be constructed within the medical record and piloted. In Aim 3, an enrollment peer support mobile application will be developed and piloted for patients with acute leukemia. Completion of these projects will result in a fully developed multilevel intervention that has the potential to sustainably diversify acute leukemia trial enrollment at scale, which will be tested through a large, randomized trial. This work will simultaneously generate replicable methods for monitoring enrollment diversity and disparities intervention assessment across institutions and cancer types. This research will be complemented by training that will cultivate expertise in behavioral intervention development, community-based participatory research, and multilevel health disparity interventions through formal coursework, workshops, seminars, and a strong team of mentors and collaborators. The work will take place within a leading cancer center that has a track record of care delivery innovation and early-career investigator success. Together, this research proposal and training plan target the primary investigator’s near-term objective of becoming an independent investigator characterizing blood cancer care delivery inequities and developing interventions to improve access, quality, and outcomes for marginalized groups. By creating a multilevel intervention that has the potential to improve the safety, efficacy, quality, generalizability, and community engagement of clinical research for diverse participants, this proposal also aligns with primary investigator’s long-term career goal of ensuring equity in blood cancer care delivery.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).