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Active NON-SBIR/STTR RPGS NIH (US)

Closing the Adolescent and Young Adult Clinical Trial Enrollment Gap with an AYA (Alert, Young Adult Navigation and Alliance) Clinical Tool

$1.67M USD

Funder NATIONAL CANCER INSTITUTE
Recipient Organization Johns Hopkins University
Country United States
Start Date Aug 20, 2024
End Date Jul 31, 2029
Duration 1,806 days
Number of Grantees 1
Roles Principal Investigator
Data Source NIH (US)
Grant ID 10947726
Grant Description

Project Summary More than 80,000 adolescents and young adults (AYAs, ages 15- 39-years) are diagnosed annually with cancer in the United States, but relatively few enroll on cancer clinical trials (CCTs). Limited AYA participation on CCTs hinders the ability to further improve AYA cancer care and outcomes. Initiatives to increase AYA CCT

enrollment is urgently needed. This proposal identifies several areas for improvement that are immediately addressable and shareable within the Sidney Kimmel Comprehensive Cancer Center (SKCCC), other medical centers, and NCI consortium groups. The approach will significantly improve AYA clinical trial participation at

SKCCC by further developing and implementing a clinical trial tool we abbreviate AYA: Alert, Young Adult Navigation, Alliance, initially within the hematologic malignancies (HM)/pediatric BMT program and then beyond. These interventions will cross fertilize collaboration at three levels: 1) Patient; 2) Multi-disciplinary

Provider and 3) Center/Systems. The solutions proposed will improve AYA access to and enrollment on CCTs, strengthen the clinical research enterprise, and address cancer disparities – all NCI priorities. This proposal will utilize a new multi-faceted alert system that includes an electronic medical record (EMR) alert to identify AYA

patients and the potential clinical trials for which they are eligible. Weekly clinical trial research meetings will

alert the multi-disciplinary team to the AYA clinical trial priority list. Patient alerts via our EMR directly linked to the patient’s mobile device will highlight CCT enrollment and upcoming appointments. Automating the identification of trial eligible AYA patients, providing timely information to the study team and physicians, and

keeping AYA patients engaged through EMR directed mobile phone messaging will optimize enrollment and compliance. A dedicated clinical research nurse young adult navigator will interact early with AYA patients, help with AYA CCT enrollment, and bridge the knowledge and workflow gap between our adult and pediatric

consortium trials. A cohort of prior AYA CCT participant survivor navigators will serve as spokespeople on our AYA website and on social media. An AYA psychosocial navigator will round out the partnership to improve AYA support. Lastly, a multi-faceted education campaign will be launched to improve alliances. NCI-

consortium enrollment issues will be highlighted at joint HM/pediatric BMT clinical research meetings. We will create cross-network enrollment FAQ documents. Using digital communication, we will provide information to AYAs about CCTs to supplement discussions with providers. We will extend the ongoing projects initiated by

the Diversity and Inclusion in Clinical Research Program at SKCCC to include an AYA patient focus to optimize the enrollment of underserved minorities. Best practices identified from this project will be readily transferrable to the entire SKCCC enterprise and other academic medical centers. As a nationally recognized BMT expert

with a strong commitment to NCI-funded clinical trials and extensive knowledge in clinical research operations, Dr. Symons is poised to lead these efforts and successfully enhance AYA accruals.

All Grantees

Johns Hopkins University

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