Johnson, Kim Barbel

Abstract Black/African American populations, globally, bear the greatest prostate cancer (CaP) burden compared to other racial/ethnic groups. Addressing CaP disparities in Black men is complex, requiring a patient-centered, community-centric and comprehensive approach. This study integrates iCCaRE Consortium findings and broader literature to address unmet needs in survivorship care. The iCCaRE Consortium implemented five complementary pilot studies using mixed-methods designs, including feasibility trials, qualitative research, and observational analyses across the United States and sub-Saharan Africa. Descriptive statistics, subgroup analyses, and qualitative thematic analyses were performed across these studies. Collectively, projects addressed multilevel determinants including social, behavioral, and biological drivers of disparities. Project 1 implemented a Virtual Reality Assistant (ViRA) across clinical and community settings, with ongoing evaluation in pragmatic trials. Project 2 showed strong patient preference for home-based cancer care. Project 3 enrolled demonstrated trends toward improved health-related quality of life. Project 4 identified key themes influencing survivorship experiences. Project 5 identified biological mechanisms linking stress, immune modulation, and symptom burden. The iCCaRE pilot projects demonstrate the feasibility and early impact of a consortium-based, transdisciplinary approach to addressing CaP disparities in Black men. These findings highlight the importance of integrating patient-centered interventions, community engagement, and biological insights to inform scalable strategies aimed at improving survivorship outcomes and advancing health equity. The iCCaRE Consortium demonstrates that a transatlantic, patient-centered, and multidisciplinary approach integrating social, clinical, and biological factors can generate scalable strategies to improve survivorship outcomes and advance equity in CaP care for Black men.

Abstract Introduction: The lack of representation of minoritized and marginalized (MaM) populations in Clinical Trials (CTs) has been noted as one of the key factors that contribute to cancer health disparities. The challenges of CT diversity are multifactorial, including barriers at the personal, provider, health systems and protocol levels. Guided by a vision of developing and implementing inclusive CTs that address the priorities identified by our communities, we created a Community Research Registry (CoRR) with three primary aims: 1. Maintaining a CoRR database of participants who may be eligible for participation in future CTs; 2. Using the database, facilitate matching of MaM populations to Clinical Trials; and 3. Facilitating access of MaM populations to CTs. Methodology: The Mayo Clinic CoRR is IRB-approved and was implemented in 2022 through bidirectional engagement of communities, partnership with community leaders to foster community input, dissemination of CT information to high-risk communities, and use of evidence-based education materials for community outreach. Participants are recruited in MaM communities (including clinics, churches, health events) and through effective use of social media. Organized events for recruitment include: 1. CT education; 2. provision of culturally tailored CT educational materials and T-shirts; and 3. data collection from those who consent to be part of the registry. The inclusion criteria for the registry are adults and ability to read and write in English or Spanish. Informed consent is obtained prior to completion of the registry form and participants receive $10 incentive. The data is collected using REDCap, and includes name and contact information of participants, demographic information, chronic disease status and explicit consent to be contacted for future research studies (with option to state type of study). New Unpublished Data: Within 7 months of CoRR implementation, 184 MaM participants signed up with 92% Black (including 10% African immigrants), 7% Hispanic, 69% female, median age of 64 years, 24% rural residents, and most of the participants had high school level education. Over 30% of participants reported medical history of hypertension, high cholesterol, arthritis and/or diabetes. 8% reported cancer. Approved investigators (with appropriate community engagement training) have direct access to de-identified CoRR information though Tableau for the purpose of estimating participants for their study. Tableau has been found to be effective for investigators to explore the database for CT/research match. All requests for participants matching are approved by a CoRR Board that includes community representatives, prior to matching. CoRR CT matching is now in its pilot phase, with Mayo Clinic studies identified for matching. Conclusion: The feasibility of the CT CoRR has been established, and has led to over 20 CoRR Champion organizations, including churches, sororities, fraternities, and the American Legion Post. Citation Format: Folakemi T. Odedina, Floyd Willis, Jennifer Crook, Emelina Asto-Flores, Kim Barbel Johnson, Chad Workman, Mayo Clinic Comprehensive Cancer Center CommunityOutreach and Engagement. Increasing clinical trials diversity through Community Research Registry (CoRR): The Community Champions for clinical trials program [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr LB112.

Abstract BACKGROUND: Despite decades of effort and proposed solutions to increase diversity in clinical trial participation, African Americans remain underrepresented. Race-specific review of clinical trial participation challenges suggests that engagement with African American physicians influence successful recruitment and appropriate enrollment of underrepresented groups in clinical research. Tailoring best-practices for minoritized populations cannot be sustainably facilitated without trusted community-academic partnerships. Engagement with African American community physicians creates capacity for leveraging resources critical to participation of African Americans in decentralized clinical trials (DCT). The Northeast Florida Clinical Trials and Translational Science (NEF-CTaTS) Consortium was formed in 2022 to address cancer health disparities experienced by minoritized, marginalized and underserved communities in NE Florida. AIM:The NEF-CTaTS Consortium convened a Focus Group with 22 African American community physicians who care for minoritized patients to solicit their input in fostering active research, research training, community outreach and engagement, and to address advantages of and barriers to forming a research network of minority physicians to conduct decentralized clinical trials and translational research. METHODS: Practicing community primary care physician members of the Northeast Florida Medical Society, a chapter of the National Medical Association where invited to participate. Physician demographic and practice information was collected from physicians who consented to participate prior to the Focus Group discussion. A Clinical Trial Needs Assessment was completed by each participating physician. The Physician Focus Group discussion was moderated by a skilled African American community physician member of the NEF-CTaTS consortium with extensive experience in conducting clinical trials. The discussion was recorded and transcribed for data analysis. IRB approval was obtained prior to informed consent, data collection and Focus Group Discussion. RESULTS: Qualitative analysis of the raw data is currently ongoing at the time of this submission. Transcribed discussion details and the observational notes identified thematic framework for descriptive statements, indexing, and sifting data. Mapping and interpretation of data is being analyzed for relationships, internal consistency, intensity of comments and specificity of responses. Analysis is scheduled to be complete within 4 weeks of abstract submission. CONCLUSIONS: Efforts to appropriately address disparities in clinical trial participation and DCT participation of African Americans require distinct and deliberate efforts to engage African American physician stakeholders. Addressing issues of trust and the impact of social-determinants of health on minoritized populations can be culturally and appropriately addressed by community-academic partnerships. Citation Format: Floyd Willis, Folakemi Odedina, Kim Barbel Johnson, Rogers Cain, Jennifer Crook. Addressing African American physician engagement in decentralized clinical trial by clinical trials and translation science consortium focus group participation [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B035.