Diversifying Acute Leukemia Clinical Trial Enrollment Through Multilevel Intervention - PROJECT SUMMARY/ABSTRACT Population differences in cancer clinical trial enrollment bias research findings, limit generalizability, and reduce 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 adults with these cancers varies by up to 85% according to demography. These leukemias have a distinct care pattern that limits the utility of existing, community-based enrollment enhancing interventions: patients require rapid inpatient therapy and up to half are seen at quaternary referral centers, where a significant proportion of uneven enrollment occurs. Modifiable elements of trial design, low provider empowerment, and patient hesitancy behaviors appear to play key roles in perpetuating poor enrollment. Recent policy and data science innovations now allow cancer registry and electronic health record data integration for enrollment 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 generalizable 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 barriers through modeling and a community-engaged assessment. In Aim 2, an enrollment generalizability performance feedback interface for acute leukemia providers will be constructed within the medical record and piloted. In Aim 3, an enrollment-focused 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 improve 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 and 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 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 barriers and developing interventions to improve access, quality, and outcomes for all patient groups. By creating a multilevel intervention that has the potential to improve the safety, efficacy, quality, generalizability, and community engagement of clinical research for trial participants, this proposal also aligns with primary investigator’s long-term career goal of improving blood cancer care delivery.
