Odedina, Folakemi T.

Abstract Background: Globally, Black men suffer the greatest prostate cancer (CaP) burden. Blacks are diagnosed more at advanced stages of CaP, greater morbidity and mortality and poorer survivorship outcomes. Blacks are exposed to adverse, discriminatory societal determinants. How these determinants impact the CaP disparities, in particular survivorship and health related quality of life inequities are understudied. Studies examining patient-reported outcomes of Black CaP survivors reveal heightened negative HRQOL sequelae, and depression, family, work and living situation instability due to cancer treatment and societal determinants of health (SDOH). SDOH is used mostly in Public Health to predict population health risk and outcomes, but rarely integrated into HRQOL research and practice. This project is novel by incorporating SDOH into the assessment and relief of HRQOL threats. Despite the Black CaP disparities in survivorship, there remains unacceptable lack of focus and prioritization to provide comprehensive relief. Methods: In response to this noticeable scientific gap, our requisite multidisciplinary investigatory team including Survivor-Advocate Investigators joins forces to achieve the study goal. We are employing community engaged research practice to create a CaP survivorship care plan (SCP) template targeted to Blacks. Our SCP will provide a comprehensive best-practice roadmap to document medical information with treatment history and status, along with relevant resources and health advisories to provide relief for unfavorable sequalae due to cancer and its treatments as well as improve quality of life for CaP survivors. We are building upon the Science of Survivorship, and Contextual Socioecological and the Behavioral Precision Medicine Models with full survivor-advocate partnership to create the SCP. This project to develop a SCP template employs an informative consensus panel to inform the initial SCP. Results: Based on advocate-survivor input and guidance, the SCP will include resources and tools focused on SDOH, treatment adherence, treatment side effects and symptom relief, co-occurring chronic conditions, cardio-protective strategies, and physical, emotional and social wellbeing towards improving in patient outcomes and HRQOL in Black CaP survivors. Data from the Engagement Core and Survivor-Advocate Community Advisory Board, and the preliminary SCP CaP for Black men will be presented at the meeting. Conclusion: Our Consortium builds upon the work of the multidisciplinary PIs, and provide team science approach with robust scientific methods to better understand and address the HRQOL needs of Black CaP survivors. Importantly, this research will make available a patient-centered SCP for CaP survivors, focused on Black men. The iCCaRE Consortium will use this SCP_CaP to inform the development of Artificial Intelligence interventions addressing medical, follow-up care, surveillance, social and emotional support, SDOH and health advisories that will be deployed on popular mobile platforms for greater reach and on-demand use. Citation Format: Kimlin T. Ashing, Folakemi T. Odedina, Cassandra N. Moore, Che Ngufor, Getachew A. Dagne, Fornati Bedell, Diana Londoño, John McCall, Arnold Merriweather, JoAnne S. Oliver, Rotimi Rotimi Oladapo. The iCCARE Consortium for Prostate Cancer in Black men: Creating a survivorship care plan for Black prostate cancer survivors [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 A033.

Abstract Background: Prostate cancer (CaP) is a global disease with the greatest burden among Black men, including sub-Saharan African men. The International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) was established by the Prostate Cancer Clinical Trials Consortium (PCCTC) as a prospective, international cohort of men with advanced cancer. The goal of the study is to establish a population-based CaP registry and recruit patients across academic and community practices globally. The Prostate Cancer Transatlantic Consortium (CaPTC) joined the IRONMAN project in 2020 with active sites in Nigeria. Aim: The overall aims of the IRONMAN cohort are to develop a global picture of advanced CaP and facilitate a better understanding of the disease relative to clinical and molecular disease subtypes, treatment patterns, therapeutic regimens with associated adverse events, patient experiences and predictors of responses and unmet needs in treatment. This report presents the experiences of a low-resourced country, Nigeria, in launching the IRONMAN study. Methods: CaPTC officially launched the IRONMAN study in Nigeria in 2021. Set up included obtaining national ethics approval, training of the multidisciplinary teams from 4 sites and 7 sub-sites, and activation of all sites. Data collection includes baseline and follow-up data from patients. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and patient-reported outcome measures (PROMs). Physician Questionnaires are also collected from all participating sites. PCCTC maintains close monitoring of the study Results: By the 9th month of the study, the Nigerian sites had recruited 54 patients who have been followed up for 3 to 9 months. There were initial challenges with start up facilities and manpower skills. The training programs have developed a multi-disciplinary team of clinical researchers across multiple institutions, now primed to conduct clinical trials. Facilitated by CaPTC, the study has also helped strengthened multi-center national and international collaborations. Additionally, there are now several clinical trials ready sites in Nigeria, facilitated by audit of the research infrastructures across Nigeria. An added benefit is that there is an opportunity to have molecular typing of CaP in Nigeria. Conclusion: The inclusion of low-resourced sites in international studies can significantly help to improve research workforce and research capacity. The CaPTC IRONMAN sites in Nigeria are top recruiting sites for the study, underscoring the benefits of biomedical research investments in Low and Middle Income Countries. The data from Nigeria would help to better understand CaP in Black men globally. Citation Format: Ademola Alabi Popoola, Chidiebere N. Ogo, Omolara Fatiregun, Mohammed Dogo, Solomon O. Rotimi, Folakemi Odedina, Prostate Cancer Transatlantic Consortium CaPTC Investigators. International Registry for Men with Advanced Prostate Cancer (IRONMAN) study: The Nigerian experience [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 A030.

Abstract Introduction: Despite the decline in overall mortality and incidence of cancer in the US population, disparities in cancer care still largely exist within certain groups. The proportion of racial and ethnic minorities recruited to participate in cancer research is persistently lower than the US population. The rapid adoption of electronic health records (EHRs) systems has enabled computational cohort identification and eligibility screening for facilitating cancer research. However, EHR data is known to suffer from data quality issues due to numerous factors, such as care access. Patients with limited care access due to low socioeconomic status would naturally be sparsely represented in EHR data relative to those of higher status. Prospective enrollees may be disqualified due to biased or incomplete EHR data at the screening stage. Methods: To systematically identify data quality variabilities in EHRs, we implemented an information score (i-score) to reflect the density, variability, and irregularity of patients’ data. The pattern can be measured by estimating the variability of the time gaps between observations. For a patient observed n times, the encountered observation times are represented as x(1)…x(n). The relative time interval g for each observed encounter can be defined as g1 = [x(i+1)-x(i)]/[x(n)-x(1)], for I = 1…n - 1. The average amount of information of each observation is then defined as I, between 0 and 1, calculated as: I = 2/n+(n-2)/n[1-sqrt((n-1)Var{gi;i=1…n-1})]. An equality-spaced observation would receive a high i-score. The lower the i-score, the higher the data irregularity. We conducted a case study in a cohort of de novo stage IV breast cancer (DNIV) assembled by a previously validated phenotyping algorithm (Wang AACR 2020). The cohort contains 1,918 DNIV cases between 2004 and 2018 at Mayo Clinic Rochester. We used the i-score to assess patient visits, breast cancer diagnosis codes, and narrative documentation, achieved by the extraction of stage, surgery, de novo, and metastasis information based on the phenotyping definitions. The summary statistics of the i-scores were compared among four racial groups: African American (3%), Asian (1%), Caucasian (87%), and Other (9%). ANOVA F test was used to compare the group differences. Results and Conclusion: The mean i-scores for visit, diagnosis and narrative documentation were 0.712, 0.200, and 0.056 for African American, 0.412, 0.301, and 0.073 for Asian, 0.438, 0.278, and 0.056 for Caucasian, and 0.519, 0.343, and 0.043 for the other category, respectively. The F test indicated significant differences between visit (p<0.001) and diagnosis (p=0.0267) data. No difference was found in narrative documentation (p=0. 8591). In conclusion, there was a substantial i-score variation discovered, especially within the African American group, suggesting a strong need to address EHR quality disparity for cancer research. Citation Format: Sunyang Fu, Liwei Wang, Folakemi T. Odedina, Hongfang Liu. Assessment of EHR data quality variabilities among different racial groups in the cohort of de novo stage IV breast cancer [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 A020.

ImportanceProstate cancer (PCa) is marked by disparities in clinical outcomes by race, ethnicity, and age. Equitable enrollment in clinical trials is fundamental to promoting health equity.ObjectiveTo evaluate disparities in the inclusion of racial and ethnic minority groups and older adults across PCa clinical trials.Data SourcesMEDLINE, Embase, and ClinicalTrials.gov were searched to identify primary trial reports from each database's inception through February 2021. Global incidence in age subgroups and US population-based incidence in racial and ethnic subgroups were acquired from the Global Burden of Disease and Surveillance, Epidemiology, and End Results 21 incidence databases respectively.Study SelectionAll phase 2/3 randomized PCa clinical trials were eligible for age disparity analyses. Trials recruiting exclusively from the US were eligible for primary racial and ethnic disparity analyses.Data Extraction and SynthesisThis study was reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Data were pooled using a random-effects model.Main Outcomes and MeasuresEnrollment incidence ratios (EIRs), trial proportions (TPs) of participants 65 years or older or members of a racial and ethnic subgroup divided by global incidence in the corresponding age group, or US population–based incidence in the corresponding racial and ethnic subgroup, were calculated. Meta-regression was used to explore associations between trial characteristics and EIRs and trends in EIRs during the past 3 decades.ResultsOf 9552 participants among trials reporting race, 954 (10.8%) were African American/Black, 80 (1.5%) were Asian/Pacific Islander, and 8518 (78.5) were White. Of 65 US trials, 45 (69.2%) reported race and only 9 (13.8%) reported data on all 5 US racial categories. Of 286 global trials, 75 (26.2%) reported the enrollment proportion of older adults. Outcomes by race and age were reported in 2 (3.1%) and 41 (15.0%) trials, respectively. Black (EIR, 0.70; 95% CI, 0.59-0.83) and Hispanic (EIR, 0.70; 95% CI, 0.59-0.83) patients were significantly underrepresented in US trials. There was no disparity in older adult representation (TP, 21 143 [71.1%]; EIR, 1.00; 95% CI, 0.95-1.05). The representation of Black patients was lower in larger trials (meta-regression coefficient, −0.06; 95% CI, −0.10 to −0.02; P = .002).Conclusions and RelevanceThe results of this meta-analysis suggest that Black and Hispanic men are underrepresented in trials compared with their share of PCa incidence. The representation of Black patients has consistently remained low during the past 2 decades.

26 Background: The underrepresentation of minority populations in clinical trials negatively impacts cancer and widens inequities. We aimed to quantify the enrollment disparities in prostate cancer (PC) clinical trials over the last three decades. Methods: MEDLINE and Embase were searched to identify primary reports of prostate cancer RCTs (1989-2020). Data for trial characteristics, the proportion of trials reporting race, ethnicity and age, and the proportion of patients by race, ethnicity and age enrolled in trials were summarized using descriptive statistics. Enrollment incidence ratios (EIR), which compare trial enrollment against global estimates of incidence in age-related subgroups (acquired from the Global Burden of Disease database) and U.S. population-based estimates of racial/ethnic subgroups (acquired from the SEER 18 incidence database) were calculated. Individual trial EIRs were pooled using random-effects meta-analyses to account for the substantial heterogeneity between trials. Multivariable meta-regression was used to explore associations between key trial characteristics and EIR. Annual percentage changes (APC) over the last three decades in enrollment disparities were analyzed using the Joinpoint Regression Analysis. Results: 281 trials from 1989 to 2020 with 99,588 patients were included in this analysis. 107 trials reported race (38%), of which only 25 trials (9%) reported data on all 5 U.S. racial categories (Black, White, Asian, Pacific Islander and Native American. 255 (91%) trials reported mean or median but only 71 trials (25%) specifically reported the enrollment proportion of older adults (age > 65 years). Clinical outcomes by race and age were reported in 9 (8%) and 37 (14%) trials, respectively. Results from meta-analyses showed that Black patients (summary EIR: 0.42 [95% CI: 0.35 - 0.51]), Hispanics (summary EIR: 0.50 [95% CI: 0.37 - 0.68]) and older adults (summary EIR: 0.95 [95% CI: 0.91 - 0.99]) were underrepresented in trials relative to their population estimates. Significantly fewer Black participants (EIR for Black patients = 0.42, EIR for White patients = 0.99; p < 0.0001), Hispanic participants (EIR for Hispanics = 0.50, EIR for non-Hispanics = 1.00; p = 0.001) and older adults (EIR for older adults = 0.95, EIR for younger adults = 1.06; p = 0.037) were enrolled. Representation of Black patients decreased significantly from 1989-2019 (APC: -4.25), while Hispanic representation increased significantly from 2000-2020 (APC: 5.89). Meta-regression showed Black patients were particularly underrepresented in larger-size trials (p < 0.0001). Conclusions: Black representation in PC clinical trials is less than 50% of their expected share based on cancer incidence and it has consistently decreased over last three decades, contributing to the disparities experienced by the population.

Abstract Purpose: Smoking rates are higher in rural regions compared to urban regions. Given the mobility within the United States, rural norms around tobacco use may persist even after individuals move to urban areas. Little research is available regarding the difference in smoking history by demographics and rural residence history. The purpose of the study was to examine the influence of age, race, gender, and rural residence history on smoking history. Methods: In a cross-sectional study, we surveyed 1,786 adults using two sampling approaches: representative panels and a community-engaged sample. Participants were asked to complete the Florida Health and Ancestry Study (FHAS) survey through a link or by the phone with a research assistant. The smoking history question asked whether participants had smoked 100 cigarettes in their lifetime (yes/no). The rural residence question asked participants to indicate (yes/no) whether they have lived in a rural or farming community, or on a farm. We examined associations of smoking history with demographic variables using the Chi-square test and logistic regression including as predictors age group (young=18-30, middle age=31-50, old=51+ years), gender, race, and rural living by gender. Results: Participants were mostly White (16% Black, 84% White), female (47% male) and with a mean age around 50 years (mean 47.9±17.5 years, ranged 18 to 91). 36% of the sample reported a history of rural residence, and 51% reported that they had not smoked 100 cigarettes in their lifetime. A larger proportion of males (61%) smoked at least 100 cigarettes compared to females (37%) (p&lt;.001). A significantly larger proportion of White participants (50%) smoked at least 100 cigarettes in their lifetime than Black participants (39%) (p=.001). A larger proportion of participants who had lived in a rural place (53%) had smoked at least 100 cigarettes compared to those who had not lived in a rural place (46%) (p=.005). Difference in mean age for those with or without a history of smoking 100 cigarettes was not statistically significant in this sample (p=.12). Logistic regression analysis revealed that relative to the old age group, the young age group was less likely (p&lt;.001) and the middle age group was more likely (p=.002) to have smoked 100 cigarettes. Males (p&lt;.001) were more likely to have smoked 100 cigarettes than females. Rural residence was associated with smoking among females (p&lt;.001) but not among males (p=.70). Adjusting for other predictors, the association with race was not statistically significant in this sample (p=.06). Conclusion: Findings that the age group 18-30 years is more likely to have avoided becoming smokers is encouraging but must be analyzed more thoroughly relative to possible use of e-cigarettes and other tobacco products. To reduce individuals becoming smokers, we recommend increased cancer control efforts targeted to males in general and to females with a rural residence history. Additional research is planned to examine additional smoking variables and compare them to national data. Citation Format: Tyra Reed, Destiny Gordon, Brenda W. Dyal, Keesha Powell-Roach, Miriam O. Ezenwa, Versie Johnson-Mallard, Janice L. Krieger, Folakemi T. Odedina, Yingwei Yao, Diana J. Wilkie. Demographic factors and rural residence history associated with smoking history [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-012.