Abstract B136: Health related social needs of people with cancer underrepresented in clinical trials: Early experience of the Cancer Research Equity and Advocacy through Engagement Initiative (CREATE) clinical trial patient navigation program
Authors: Collins Ashley Rankin , Morris Hayley N. , Matthews Lauren N. , Buenaventura Gomez Omar N. , Charlot Marjory 
Published: September 2024

Background: Black and African Americans (AA) remain severely underrepresented in therapeutic oncology clinical trials (TOCTs) and have the highest cancer mortality rates compared to all other groups. Racially biased clinical trial offers, poor physician-patient communication, and social determinants of health largely contribute to these racial inequities. The UNC Lineberger CREATE Clinical Trial Patient Navigation (CTPN) program was established to advance racial equity in TOCT participation. The CTPN program entails clinical trial education, facilitating communication between patients and their medical/research team, identifying barriers to clinical trial participation and connecting patients to resources to address those barriers. Here we describe the health-related social needs and referrals made to address those needs. Methods: The CTPN program employed a targeted proactive approach to reach patients with a new cancer diagnosis who self-identified as Black/African American (AA) or were insured by Medicaid. The patient navigator used the electronic medical record (EMR) to review the oncologist's schedule to identify patients meeting the above criteria. Identified patients received a letter in the mail describing the CTPN program and were offered an in-person clinic visit and/or telephone call with the patient navigator. During these encounters, the patient navigator assessed clinical trial barriers including health-related social needs and made referrals to resources to help address these needs. The CTPN program was initially launched in the thoracic oncology clinic but later became available for direct referrals from all oncology groups. Results: In the first 18 months of the CTPN program, there were 292 patient encounters among183 unique patients who received navigation services. Most patients (83%) were identified through the EMR, 79% identify as Black or AA, 64% have Medicaid. Patients had a diagnosis of lung (62%), head and neck (18%), gynecological (9%), and breast (2%) cancers. Clinical trial related barriers and health-related social needs included lack of clinical trial knowledge (68%), housing (9%), transportation (26%), financial support (18%), and family/caregiver support (14%). CTPN program materials were provided to address clinical trial informational needs (78%), and referrals were made to assist with emotional (13%), logistical (20%), and financial (21%) needs. On average, 2 referrals were made per patient encounter. Conclusion: CTPN can engage Black/AA patients with cancer using a proactive EMR approach to identify patients and may help address health-related social needs to facilitate cancer care and potential clinical trial participation. Future work will evaluate the impact of CTPN on enrollment of Black/AAs in therapeutic cancer clinical trials.

Citation Format: Ashley Rankin Collins, Hayley N. Morris, Lauren N. Matthews, Omar N. Buenaventura Gomez, Marjory Charlot. Health related social needs of people with cancer underrepresented in clinical trials: Early experience of the Cancer Research Equity and Advocacy through Engagement Initiative (CREATE) clinical trial patient navigation program [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B136.