Odedina, Folakemi T.

Abstract Introduction: Underrepresented communities experience a lack in research participation due to multifaceted barriers including historical research mistrust, language barriers, transportation inaccessibility, and other social determinants of health. The disproportionate representation in racial, ethnic, and medically underserved communities furthers the gap in health disparities and treatment outcomes. For this reason, the Mayo Clinic Community Research Registry (CoRR) was developed in 2022 to specifically create a registry of underrepresented communities and connect them to research studies. Methodology: Mayo Clinic CoRR utilizes a community based participatory research (CBPR) approach involving bidirectional engagement with community participants, partnership with community stakeholders and leaders, dissemination of clinical trial information, and use of evidence-based education materials for community outreach. CoRR community partnerships include fraternities, sororities, churches, the American Legion, local physicians, pharmacies, clinics, and health fair events. Through questionnaires, study participants indicate the level of research participation they are comfortable with and are matched to research studies based on their individualized responses. New Unpublished Data: As of early June 2023, CoRR has 270 participants enrolled in the registry with 94% of participants being Black and 6% Hispanic. Average age of the participants is 63 years and includes 63% female and 37 % male. As community input is vital to its development, Mayo Clinic CoRR has partnered with a community advisory board for ongoing discussion of study procedures and recruitment initiatives. This feedback has resulted in over 25 protocol modifications from bidirectional community input and engagement with the study to tailor it to community needs. Revisions include modification of inclusion and exclusion criteria to allow interested, low literacy participants to join, offering written and online platforms for participation in Somali, French, and Creole languages. CoRR adaptations have also implemented a community newsletter to visually provide updated CoRR information, highlight research studies in which CoRR participants have been included, as well as engage CoRR participants regularly. Future developments for CoRR include the establishment of an ad hoc Committee with registry participants to provide another level of safeguarding for enrolled CoRR participants. Conclusion: Responsivity to the needs of the community is vital for the continued development and success of Mayo Clinic CoRR, which has led to a successful ongoing enrollment of underrepresented communities into research studies. By utilizing targeted CBPR, the CoRR demonstrates a proof of concept in recruiting and retaining participants in hard-to-reach demographics with the goal of reducing health disparities in chronic diseases, including cancer. Citation Format: Emelina Asto-Flores, Chelsea Mir, Sandy Goncalves, Giovanna Moreno Garzon, Nuwanthi Heendeniya, Jennifer Crook, Folakemi Odedina. Increasing involvement and accrual in research studies from communities of underrepresented populations through the lens of a community based participatory approach via the Community Research Registry (CoRR) [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A038.

Abstract Despite notable progress in early detection, prevention, and treatment of prostate cancer within the United States, racial disparities are present very early in the patient journey of Black men, starting with the shared decision-making process. The disproportionately higher number of Black men diagnosed with prostate cancer also suggests that Black men must also contend with the management of associated physiological and psychosocial symptoms. The survivorship care plan was designed to communicate critical information that cancer survivors and their health care advocates need as a guidebook for long term post treatment care, and improved survivorship. An associated systematic literature review conducted by our multidisciplinary investigative team revealed there was a severe underutilization of survivorship care plans within cancer survivorship care especially with Black men. The considerable lack of utilization and/or tailoring of survivorship care plans may be a significant contributor to the worsening of health disparities in this population. Co-designing survivorship care plans with key stakeholders, specifically Black survivors and their health care advocates, is imperative to ensure that the plan meets the needs and preferences that Black men have for survivorship care. This presentation will discuss the steps the investigative team used to address the disparities in shared decision-making, and the subsequent underutilization of survivorship care plans. The investigative team utilized semi-structured interviews and focus group methodology to explore how the lived experiences of Black male prostate cancer survivors are incorporated and addressed in the construction and contents of a culturally tailored survivorship care plan (CaP_SCP- Black Men). An evaluability assessment was conducted to determine whether implementation of the newly created survivorship care plan is feasible, appropriate, and addresses the specific needs of the population before full implementation. This presentation will discuss how this combination of approaches allowed the investigative team to understand how survivorship care plans affect the unique complexities of survivorship in Black men, and allows for the feasibility study of the implementation of a culturally relevant survivorship care plan (CaP_SCP- Black Men) in a population that bears the greatest burden nationally and globally. Citation Format: Timethia Bonner, Kimlin Ashing, Folakemi Odedina. The iCCARE Consortium for Prostate Cancer in Black men: Evaluability assessment of the implementation of a care plan for black prostate cancer survivors [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A041.

Abstract Black men are disproportionately affected by prostate cancer (CaP), with limited progress in closing the CaP care and survivorship gaps experienced by Black men compared to other racial/ethnic groups. Unfortunately, there is an uptick in CaP incidence rate in the United States (US) since 2014. As reported by the American Cancer Society, the rising CaP incidence rate indicates a shift towards higher grade and stage during diagnosis. The prostate cancer (CaP) disparities experienced by Black men in the US is a microcosm of the global burden of CaP seen in men of African ancestry. For example, the top ten countries leading CaP mortality in the world are all Black nations in Africa and the Caribbean. The complexity of CaP disparities and the need for a unique approach to better understand and address a complex chronic disease, such as CaP, underscores the need for consortium research that is multilevel, collaborative, translational, and global. Through the Department of Defense funding, we formed an inclusive Cancer Care Research Equity (iCCaRE) for Black Men Consortium to advance health equity and reduce disparities in CaP. Comprising CaP survivors, advocates, scientists, and clinicians, the iCCaRE for Black Men Consortium addresses structural, social and biological determinants of CaP among ethnically diverse Black men globally, including US Black men, West African immigrant men in the US and indigenous West African men. The overall goal of the iCCaRE consortium is to optimize CaP diagnosis experiences, treatment and survivorship based on the Science of Survivorship (SOS). Our central hypothesis is that improving social-determinants of health (SDOH) factors, CaP care and survivorship (CaPCaS)-related factors and mediating biological factors will lead to an improvement in patient-reported outcomes (PROs). This presentation will highlight the structural inequities, societal injustices and biological determinants found to be associated with CaP care and survivorship among Black men. Additionally, we will present the use of Community Living Lab (CoLLab) Health System approach to address inequity in minoritized and marginalized communities. Citation Format: Folakemi Odedina, Roxana Dronca, Kimlin Ashing, Ernest Kaninjing, Solomon Rotimi, Che Ngufor, Arnold Merriweather, iCCaRE Consortium. Science of prostate cancer care and survivorship in black men: Structural, social and biological determinants [abstract]. In: Proceedings of the AACR Special Conference: Advances in Prostate Cancer Research; 2023 Mar 15-18; Denver, Colorado. Philadelphia (PA): AACR; Cancer Res 2023;83(11 Suppl):Abstract nr IA007.

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 BackgroundNigeria has the highest cancer burden in Africa with 124,815 cancer cases and 78,899 cancer deaths in 2020. The limited number of oncology specialists, inaccessibility of essential cancer medicines like chemotherapies, and suboptimal delivery of cancer care lead to poor treatment outcomes. Oncology pharmacy (OP) practitioners are critical oncology professionals in the multidisciplinary team (MDT) for cancer treatment globally. In Nigeria, there is a limited number of OP practitioners providing services like reconstitution of chemotherapy, clinical research, safe use of biosafety cabinets, and monitoring of adverse drug reactions. Although the interest in oncology pharmacy is increasing, the educational needs, available skill sets, and directed training in oncology pharmacy across the nation are unknown. In this study, we examined the educational needs of OP practitioners and worked with the West African College of Pharmacy West African Postgraduate College of Pharmacists (WAPCP), Oncology Pharmacy Practitioners Association of Nigeria (OPPAN), and the International Society of Oncology Pharmacy Practitioners to upgrade the oncology pharmacy practice in Nigeria. MethodA cross-sectional study with a semi-structured questionnaire was done in 2021 with 39 pharmacists working in oncology centers across Nigeria. General descriptive statistics and qualitative analysis was performed. ResultsThere is no board-certified oncology pharmacist in Nigeria. More than 50% of the general pharmacists working in oncology centers are responsible for chemotherapy reconstitution. Understanding chemotherapy reconstitution (automation of chemotherapeutic mixing, use of radiopharmaceuticals, etc), use of biosafety cabinets, knowledge of pharmacology, designing treatment protocols, data management, immunotherapy delivery, and oncology clinical trials were some of the most significant educational needs of the OP practitioners in Nigeria. OP practitioners are lacking in most cancer centers and MDTs. ConclusionThere is an urgent need for a specialty postgraduate training programme in oncology pharmacy in Nigeria. This would help increase oncology clinical trials, improve delivery of cancer medicines, quality of care, and management of toxicities. The West African Postgraduate College of Pharmacists and OPPAN need appropriate training resources to develop an oncology pharmacy curriculum, promote the specialty and collaborate with global institutions for board certifications. Citation Format: Runcie C. Chidebe, Ramatu M. Alabelewe, Darlingtina K. Esiaka, Gloria C. Okwu, Tochukwu C. Orjiakor, Nwamaka Lasebikan, Jacinta Emejulu, Adamu A. Umar, Ndifreke Okwuegbunam, Funsho David, Toyosi Adepoju, Krishna Prasad Sapkota, Candidus C. Nwakasi, Agha A. Agha, Simeon C. Aruah, Katy Graef, Richard Mshelia, Rob Duncombe, Matthew O. Nwaneri, Noel Wannang, Cindy O’Bryant, R. Donald Harvey, Peace C. Babalola, Folakemi T. Odedina. Who reconstitutes my chemotherapy? Examining the educational needs of oncology pharmacy practitioners in Nigeria [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 723.

Abstract Introduction: Black men are disproportionately affected by prostate cancer (CaP) and havebeen found to experience more aggressive forms of cancer. The Minority Prostate Cancer(MiCaP) Research Digest is a dissemination platform with the goal of spreading community-based and culturally relevant ways to provide prostate cancer discoveries, interventions, andclinical trials among Black men. In collecting pretest data, the MiCaP team was also able tocollect data on whether participants had been tested for CaP in the last year. We were also ableto collect data on various social determinant variables to test for association. Methods: Black men living in the United States ages 35 to 70 were recruited for this studythrough community-based methods. Participants were randomly assigned to an interventiongroup that received the MiCaP information material and a control group that watched a generalvideo. Both groups received baseline and follow-up surveys to assess their knowledge relatedto CaP clinical trials, testing, and treatment. Associations of characteristics from the baselinesurvey were evaluated using logistic regression models. Results: A total of 220 responses are included in this dataset. The majority of participants wereborn in the United States (93.06%), single (49.52%), attended/graduated college (35.65%),between 60 and 69 years (25.58%), had full-time employment (52.07%), and had a householdincome between 20,000 and 39,999 (21.66%). Only about 35% had read or heard about clinicaltrials within the last year. Logistic regression found a positive association between the followingvariables and getting tested for prostate cancer in the past year: if participants had heard ofcurrent prostate cancer research or discoveries, if an immediate family member had beendiagnosed with prostate cancer, age, and level of education. No association was found betweeninsurance status, utilization of healthcare, clinical trial participation, or clinical trial knowledge. Conclusion: There is an association between being aware of CaP discoveries, diagnosis of familymembers, education, and age with prostate cancer screening. Future work should be done tofurther explore this association and how to overcome the barriers those determinants mightprovide in screening. These data and future data on this can be used to further community-based interventions delivered in culturally relevant ways with the goal of encouraging positivehealth behaviors to reduce CaP in Black men. Citation Format: Jessica Otero Machuca, Parisa Fathi, Daniel Lee, Kim Walsh-Childers, Folakemi Odedina. Potential predictors of prostate cancer screening: Findings from the MiCaP research digest study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1972.

Abstract BACKGROUND Black populations are disproportionately affected by prostate cancer globally. The leading countries in prostate cancer mortality are found in Africa and the Caribbean. This data is being presented as part of the Prostate Cancer Transatlantic Consortium (CaPTC) Prostate Cancer Familial Cohort Study of African Ancestry study with the purpose of identifying the various factors that influence prostate cancer risk factors. Access to care, a known cancer risk factor, not only affects a person’s ability to receive treatment but to receive accurate health information, preventative care, diagnoses, and more. Researching exactly how different social determinants, such as this one, affect cancer risk factors for specific populations is imperative to reducing their cancer burden. METHODS: This ten-year prospective study started in 2017 and has been conducted in Nigeria, Cameroon, and the United States. Participants have been recruited in clinics and different community settings. Upon consent, participants were asked to complete a validated survey with a unique identifier on epidemiological, behavioral, clinical, and anthropometric variables. They were then asked to provide a saliva sample that was also given a unique identifier. Associations of characteristics from the survey were evaluated using logistic regression models. Others were tested for statistical significance using a Chi-Squared test. RESULTS: A total of 803 responses are included in this dataset. Of these participants, 9.6% were from Cameroon, 82.6% from Nigeria, and 7.3% from the United States. More than half of the participants (54.9%) shared they did not have healthcare coverage. In addition, a chi-squared test showed 10.2% in the United States, 13.9% in Nigeria and 35.1% in Cameroon were unable to see a physician due to cost with a p-value of less than .001 indicating statistical significance. While participants in the United States did not report any cancer diagnoses, logistical regression found a significant inverse relationship between health literacy and increased risk of a cancer diagnosis. CONCLUSION Research shows a relationship between health access factors and cancer risk factors, but little research is done for specific populations. Further research should be done to measure the exact impact access to care has on cancer diagnoses for specific communities. It is very important that health equity researchers assess exactly how these factors affect the specific populations they work with to tailor evidence-based interventions to their needs. Citation Format: Jessica Otero, Emeka Iweala, Ademola Popoola, Paul Jibrin, Mohammed Faruk, Anthonia Sowumi, Omolara Fatiregun, Nkegoum Blaise, Catherine Oladoyinbo, Ifeoma Okoye, Abdulkadir Ayo Salako, Abidemi Omonisi, Iya Eze Bassey, Kayode Adenji, Nggada Haruna Asura, Ernest Kaninjing, Oluwole Kukoyi, Parisa Fathi, Ruth Enuka, Oluwaseyi Toye, Jennifer Crook, Folakemi Odedina. Influence of access to care on cancer diagnoses in the CaPTC Prostate Cancer Familial Cohort Study of African Ancestry in Nigeria, Cameroon, and the United States [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 B072.

Abstract Introduction: According to the American Cancer Society’s Cancer Control Blueprint, one of the reasons for the underrepresentation of minorities in clinical trials (CTs) is lack of engagement and effective recruitment of minoritized populations. This has inadvertently impacted the willingness of minorities to participate in CTs. The Minority Prostate Cancer (MiCaP) Research Digest is a dissemination platform that shares the latest scientific discoveries about prostate cancer (CaP) research, targeting Black men (BM), a population that is historically difficult to enroll in CTs. This study explored the willingness of BM in participating in various CTs. Methods: BM between the ages of 35 and 70 years who reside in the U.S. and have internet access were invited to enroll in the MiCaP study. Participants were randomly assigned to an intervention group exposed to the research digest (video and educational materials about a research study and CT) and a control group. Enrolled participants completed baseline and follow-up surveys with questions focused on willingness to participate in CTs. Descriptive statistics was employed to compare the groups on baseline and follow-up responses. Results: Majority of participants were US-born BM (93.06%), single (49.52%), attended/graduated college (35.65%), between 60 and 69 years (25.58%), had full-time employment (52.07%), had household income between 20,000 and 39,999 (21.66%) and live in urban setting (75.46%). However, only about 35% had read or heard about clinical trials within the last year. Only 14% reported they had been asked to participate in CTs within the last year, and more than 70% indicated that they would participate asked. Participants were asked to state the type of CT activity they would be willing to participate in within the next year. For the intervention group, the percentage of participants willing to participate in CTs increased for almost all activities (except major surgery). There were also slight increases in the Control group with the largest increase in being on a limited or restricted diet (+8.53%). Over 70% of all participants were willing to participate in trials that involved giving blood, doing exercises, being interviewed in person or by phone, completing a survey, being on limited diets and taking pills. Interestingly, undergoing minor surgery had the largest increase relative to CT participation (+6.9%). Participants were also asked to express their perceived behavioral control (BC) by indicating the ease of participating in CTs and finding information about CaP. As expected, the percentage of intervention group participants with high BC (selected very easy or easy) increased from baseline to follow up. Conclusion: With appropriate engagement and culturally responsive educational materials, BM are receptive to participating in a variety of CT activities. It is however important to note that the Black population is ethnically and culturally diverse, and thus the engagement and education should be tailored based on the men’s needs, ethnicity, and cultural views. Citation Format: Parisa Fathi, Kim Walsh-Childers, Folakemi Odedina. Black men's willingness to participate in prostate cancer clinical trials: Demystifying clinical trial activities through the MiCaP Research Digest study [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 B083.

Abstract INTRODUCTION The Prostate Cancer Transatlantic Consortium (CaPTC) has the goal of better understanding the burden of prostate cancer among Black men of West African descent. While prostate cancer disproportionately affects Blacks around the world, little research is done to understand what mental health and social support play a role in prostate cancer risk factors. The purpose of this 10-year longitudinal study is to establish a cohort of U.S.-born Black men, West African-born Black men who reside in the U.S, and West African Black men in Africa who would be prospectively and longitudinally followed to better understand the cause of prostate cancer and how different factors might influence it. METHODS Study staff partnered with community-based organizations, events, and stakeholders to engage with the priority population. Snowball sampling was also used for recruitment. All participants were made aware of the longitudinal nature of the study and that they would be contacted every two years for follow-up. Informed consent was done in community settings electronically and on paper. Once consent was received, participants completed the survey with a unique identifier and filled out a Cohort Contact sheet. They were given the option to complete this on their own or with the help of the study staff. Study Staff would then measure participants’ weight, height, and waistline, to be recorded on the survey form. After this, participant saliva was collected and tracked with the unique identifier. All collected data was stored on RedCap and a Chi-squared test was utilized to identify statistical significance. RESULTS 803 participants are included in this data with 77 in Cameroon, 663 in Nigeria, and 59 in the United States. When asked about emotional support, 13.6% (US) 11.8% (Nigeria), and 14.3% (Cameroon) indicated never or rarely having emotional support. 5.8% of those in the United States, 5.6% of those in Nigeria, and 7.8% of those in Cameroon felt dissatisfied or very dissatisfied with their lives. The p-value for both was found to be <0.001, therefore, suggesting statistical significance. On the other hand, participants described having an average of 6.53 (US), 9.4 (Nigeria), and 8.26% (Cameroon) days where their mental health was not good. However, this was statistically insignificant with a p-value of .95. CONCLUSION Mental health issues have been on the rise since the COVID-19 pandemic. While many people of color have stigmatized needing mental health help, it is important to find ways to overcome this barrier in assessing mental health and social support needs. Future research should continue to ask mental health and social support questions in order to assess their role in prostate cancer risk factors. Citation Format: Jessica Otero, Emeka Iweala, Ademola Popoola, Paul Jibrin, Mohammed Faruk, Anthonia Sowumi, Omolara Fatiregun, Nkegoum Blaise, Catherine Oladoyinbo, Ifeoma Okoye, Abdulkadir Ayo Salako, Abidemi Omonisi, Iya Eze Bassey, Kayode Adenji, Nggada Haruna Asura, Ernest Kaninjing, Oluwole Kukoyi, Parisa Fathi, Ruth Enuka, Oluwaseyi Toye, Jennifer Crook, Folakemi Odedina. Quality of life indicators including mental health factors in CaPTC prostate cancer familial cohort study of men of African Ancestry in Nigeria, Cameroon, and United States [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 B073.