Increase Minority Participation Research Articles

Abstract IA028: Achieving health equity: Inclusive participation in clinical trials

Abstract Minority participation in clinical trials is imperative to develop new prevention, detection, and treatment modalities for cancer because study samples must be representative to generalize findings to the disease population. As of 2020, low-SES populations, which have minority race/ethnicity prevalence, saw significantly greater risk from cancer mortality than their White, higher-income counterparts. This population has higher mortality from breast cancer (+10%), prostate cancer (+16%), colorectal cancer (+17%), and liver cancer (+26).1-2 Myriad drivers of health inequities3 act as barriers to clinical trial participation.1 Patient barriers include sociocultural and physical environment factors, while physician’ barriers include perceived loss of control, uncertainty, and lack of time to discuss research options.1 For example, 87% of patients surveyed in 2020 reported never having been invited to participate in a clinical trial with 41% not knowing anything about clinical trials; 9% had been asked, with <5% participating. Disparities were evident by minority race, low education level and income, and rurality.1,4 Retention and compliance barriers included participants’ loss of interest in the study, not having been assigned to a desired treatment, older age, low education, unemployment, and logistical barriers, such as transportation and child-care.4-5 Incorporating patient navigation programs into clinical trials helps correct for misinformation and builds trust between researchers and community members.5-7 The Increasing Minority Participation in Clinical Trials (IMPaCT) study (2007-2014, N=272), trained lay patient navigators (PNs) to guide patients through the eligibility process to enroll in cancer clinical trials at UAB. PNs also provided tailored support, including assistance with transportation and lodging, appointment reminder calls, social service referrals as appropriate, and linking patients with peer support. African American participation in therapeutic cancer clinical trials increased from 9% to 16%.4,6 UAB has had similar success with other patient navigation and health coaching studies, confirming PN benefits.8-10 An often overlooked barrier is researcher or physician implicit bias and the role bias plays in study design, particularly with regard to participant recruitment.11 Although everyone has biases, acknowledging how those biases affect our judgement and behaviors can be uncomfortable to process.12 When we address bias directly and take purposeful actions to mitigate implicit bias, patients benefit, enrollment increases among the populations most at risk, and results become generalizable.13-14 With the increasing amount of readily-available population-level data on incidence and mortality from various types of cancer registries, likely barriers to participation, including both patient-and researcher-centered, can be identified early in a study’s development and addressed during plan development. Finally, incorporating patient navigation into recruitment plans will enhance enrollment in cancer clinical trials. Citation Format: Mona N. Fouad. Achieving health equity: Inclusive participation in clinical trials [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 IA028.

Abstract IA030: Ensuring diversity in clinical trials

Abstract It is well known that minorities, particularly Blacks, are underrepresented in cancer prevention, early detection, and treatment trials. However the mortality rates for Blacks are significantly higher than other race/ethnic groups. Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. Being able to identify and resolve social determinants of health is essential for clinical trial participation. It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Utilizing embedded community academic sites to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials is warranted. Considerable attention has focused on the need to increase underserved racial and ethnic populations in clinical research, especially in light of the cancer health disparities that disproportionately plague these groups. Clinical trial design and implementation are time-consuming and require a multistep process that is complicated by other factors, including eligibility criteria for clinical trials for underserved racial and ethnic populations, recruitment processes, and patients’ misconceptions or lack of information about clinical trials. Georgetown-Lombardi National Capital Area Minority/Underserved NCORP (NCI Community Oncology Research Program) coupled with the Ralph Lauren Center for Cancer Prevention will reveal strategies and approaches instrumental to our success. These efforts resulted in the development of a strong community capacity–building and clinical research cancer recruitment strategy, and improved engagement of the community in clinical research, thus ensuring diversity in clinical trials. Citation Format: Lucile Adams-Campbell. Ensuring diversity in clinical trials [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 IA030.

Strategies to increase minority participation in clinical trial screening and enrollment in an urban academic public hospital (2237)

Strategies to increase minority participation in clinical trial screening and enrollment in an urban academic public hospital (2237)

Abstract B091: Introduction of Implicit Bias Training to oncology faculty as a means to improve minority participation in cancer clinical trials

Abstract Background: Following George Floyd’s murder in May 2020, conversations about equity and bias became part of our daily national conversation. Simultaneously the COVID-19 outbreak disproportionately affected people of color which further illuminated existing disparities in outcomes. Bias training was introduced in many sectors as a strategy to address inequity. Inclusivity in healthcare is essential to develop evidence-based therapies and treatment plans. Previous studies have demonstrated the consequences when racial and ethnic minorities are excluded from research. (Hamel et al, 2016). Racial and ethnic minorities disproportionately bear adverse outcomes from cancer. Cancer clinical trials would benefit from solutions to promote inclusivity. (Khan et al. 2021) Research Purpose: The purpose of our study was to assess whether Implicit Bias Training can increase minority participation in cancer clinical trials. Methodology: The Office of Diversity, Equity, and Inclusion offered Implicit Bias Training to all clinical oncologists at the Yale Cancer Center (YCC) between May and July 2021. While 109 physicians were eligible to participate, 57 physicians were required by the department to complete this training, and 84% of these physicians completed this opportunity. We analyzed YCC clinical trial enrollment data between two time periods defined as pre-intervention and post-intervention. We selected these periods to investigate not only the efficacy of bias training but specifically bias training as an adjunct to the national conversation during the time of our study. We selected the preintervention period as January 1, 2021, to June 30, 2021. The intervention was designed to be completed by July 1, 2021 therefore the post-intervention period is defined as July 1, 2021 to December 31, 2021. Results/Summary: Our analysis showed an increase of 2.5% in the participation of Black/African American patients. There was a slight (1.5%) decrease in Hispanic patient enrollment during this time. Conclusion: Our analysis suggested that implicit bias training delivered once had only a very modest, if any, improvement in racial minority participation in cancer clinical trials. Our project focused on participation by Black/African American patients. The impediment to Hispanic participation is quite nuanced. Hispanic patients, many of whom are non-English speaking with immigration/insurance issues face additional structural barriers. We think that a different strategy is needed to better serve this patient population. While we had hoped for metrics to demonstrate greater impact from bias training, our next investigation will look at if the intervention is best delivered repeatedly. Future Work: We have not abandoned the strategy of bias training to build trust and increase Black/AA participation. After the intervention, we are interested in whether greater impact is seen over time. We have designed a survey to look at the effects of the intervention after a year. Our next step is to examine whether repeated delivery of this intervention will amplify our results. Citation Format: Renee Taylor, Andrea Silber. Introduction of Implicit Bias Training to oncology faculty as a means to improve minority participation in cancer clinical trials [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 B091.

Abstract B089: Barriers and facilitators to recruiting minorities into clinical trials: Research staff perspectives

Abstract Background: The recruitment of ethnic minorities into clinical trials and cancer research is a formidable challenge. Minorities constitute 42% of the US population, however, they generally don’t reach their proportional representation in clinical trials. Latinos make up only 2.6% and African Americans only 6% of therapeutic cancer clinical trial participants. Additionally, minorities experience higher incidence rates and worse outcomes compared to their non-Hispanic White counterparts. To date, barriers and facilitators for the recruitment of minorities into clinical trials focus mostly on the patient and physician level. This study examined the facilitators and barriers for clinical trial participation among minorities from the perspective of principal investigators/clinicians, study staff, and research support staff at a comprehensive cancer center. Methods: A mixed-methods design combined quantitative and qualitative approaches to evaluate factors that would facilitate recruitment of minorities into research form the perspective of principal investigators/clinicians, study staff, and research support staff. Six focus groups were conducted with 3 different groups (principal investigators/clinicians, study staff, and research support staff) to identify the facilitators and barriers. Participant also completed a short survey. Results: A total of 27 focus groups participants participated across the 6 virtual focus group. Most (83%) were female, heterosexual (92%), single (46%), and Latino (61%). Most (50%) are not asked to provide input during the design of the study protocol and recruitment efforts but would like to (67%). Most (71%) stated that language is barrier to enrolling patient onto clinical trials. Most (75%) stated that patient would benefit from a patient navigator to provide clinical trial navigation. Most (67% stated that not enough funding is allocated to recruitment efforts and most (75%) stated they would benefit from training on how to recruit minorities into clinical trials. Several barriers and facilitators emerged during the focus groups including barriers such as lack of diverse staff, lack of in language consent forms, insurance coverage, and lack of diverse patients. The facilitators identified include racial/ethnic concordance for recruiter and patient, language concordance, in-language materials, sufficient time allotment, and funding for recruitment (e.g., transportation vouchers, flyers). Conclusions: Across all participants groups (Principal investigators/clinicians, study staff, and research support staff) there were many similarities in the perceived barriers and facilitators to recruiting minorities into clinical trials. The main emerging theme was hiring a diverse staff for racial/ethnic and language concordance as well as providing staff training on engaging minorities. This study highlights perceived barriers and facilitators to increase minority participation in cancer clinical trials from the perspective of research staff. Citation Format: Mayra Serrano, Rick Kittles, Leanne Burnham, Kimlin T. Ashing, Dorothy Galloway, Danielle Guardado. Barriers and facilitators to recruiting minorities into clinical trials: Research staff perspectives [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 B089.

The Lived Experience Of Latinx‐Americans And How Researchers Can Build Stronger Partnerships To Improve Research

AbstractBackgroundThe Latinx population is growing in the United States, and yet recruiting participants at representative rates into research for dementia is an ongoing challenge. This group is additionally facing the largest increase in Alzheimer’s Disease and related dementia diagnoses; however, literature indicates their contribution is regularly absent from related research and clinical trials. Representative recruitment to research is critical to ensure the outcomes of research are applicable and generalizable to this large population group. Hearing and understanding the lived experience of individuals from Latinx communities is key to addressing barriers to participation. Literature around increasing minority participation notes approaches of personalization are essential in reaching Latinx groups. This session will assist researchers in tailoring strategies of recruitment and methods of engaging with the latinx population by providing the necessary platform and direct connection to this community.MethodThe panelist, selected by the Biggs Institute research team, will share their lived experience with ADRD diagnosis, care, and/or research participation. As part of the South Texas ADRC, the Biggs Institute selected panelist will provide the perspective of Latinxs living in south Texas and along the border, specifically addressing the unique challenges faced in accessing care and research. They will communicate their connection to research, personal and potential cultural barriers to research involvement, and share what researchers can do to build better partnerships with Latinx communities.ResultThis session will highlight the Latinx perspective related to dementia research and will offer the opportunity for further understanding around the experience of individuals in minoritized communities. Attendees will hear the perspective of the Latinx community to prompt improved methods of inclusion. This session aims to benefit researchers, and those in the field of aging and dementia research, by providing perspectives crucial to the development of strategies to facilitate engagement with a more demographically diverse community.ConclusionThe voice of Latinx individuals is essential to include when discussing research priorities and addressing the challenges to increase diverse research participation. Improving inclusivity in ADRD research will improve relevance of findings, and sharing diverse perspectives is a first step to build meaningful partnerships with the latinx community.

Abstract PO-034: Is clinical trials the answer to cancer: Preliminary results from City of Hope Multi-ethnic Community Engagement Program

Abstract Background: The biomedical community is struggling to develop viable strategies to increase ethnic minority enrollment in studies – a result of both historical and current medical injustices in communities of color. Therefore, we aimed to reach multiethnic community health leaders to determine barriers and facilitators of research participation by providing an educational program that focuses on the importance of ethnic minority participation in research. Methods: We conducted a stakeholder evaluation study as part of a community research engagement education program. An online survey was administered to community ambassadors (N=88) representing multiethnic health organizations from across Southern CA as well as an On-Demand “Community Research Navigator (CRN)” education program; that brought awareness of the importance of clinical trials. Participants were identified and provided the survey link by the leadership of our partners. Participants were asked to rank barriers and facilitators of research participation of their communities from least to greatest and complete the educational component. Results: Respondents were Korean-American (35%), African-American/Black (33%), Filipino-American (18%), and Latino (14%). Respondents were mostly female (88.10%) and 45-55 years old (33.33%). Participants ranked fear of biomedical research, lack of provider invitation; lack of diversity in the researchers doing the research, language, cost/coverage barriers as the top 5 barriers. The top 5 methods endorsed by participants to increase minority research participation were increase knowledge and awareness for patient and family; provide coverage/compensation; increase diversity among researchers, provider and broad media, referrals, and ensure practical facilitators. We found CRN training results showing increases in 28% of respondents feeling prepared to help their community overcome barriers to accessing medical research, 29% feeling prepared to help their community with trust and willingness to participate in medical research; and 26% feeling prepared to navigate their community into trial studies. Conclusions: Findings suggest that barriers to research participation are influenced by multiple factors including structural (health system, lack of minority scientists), societal determinants (discrimination, cost), and social (interpersonal, familial, cultural) and emotional (fear) factors. Therefore, strategies to increase minority participation in biomedical studies must attend to barrier domains. Our community Ambassadors emphasized, that the social component refers to the significant systemic barriers especially the intersection of cost and racism in the medical sector rooted in societal determinants including medical/scientific discrimination. These findings provide a broader contextual conceptualization of barriers to inform novel strategies including CRN to increase community leaders preparedness for greater diversity engagement and participation in biomedical studies as an achievable answer to cancer disparities and cancer, overall. Citation Format: Kimlin Ashing, Marisela Garcia, Sophia Yeung, Alejandro Fernandez. Is clinical trials the answer to cancer: Preliminary results from City of Hope Multi-ethnic Community Engagement Program [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-034.

Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial

While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites).RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8).In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts.TRIAL REGISTRATIONClinicalTrials.govNCT01911208

From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology

From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology

Abstract A089: Addressing both community and institutional barriers increases accrual of minority patients in breast cancer clinical trials

Abstract Background: Clinical trials (CT) allow new treatments to become standard practice. Diversity in CT benefits both participating and future patients, but traditionally underserved ethnic/racial minorities participate in CT at lower rates than Whites. Previous studies have claimed that personal and community barriers prevent participation, but the intersection of community and institutional factors has been understudied. For the past two years, the Oncology Welcomes New Haven into Trials (OWN IT) initiative at the Yale Cancer Center has taken a multitiered approach to breast cancer minority CT accrual. Methods: Focus groups at community centers were held to better understand community perspectives on CT. Ongoing outreach was performed by physicians and community health workers at local events. Institutional barriers were addressed through executive council representation, grand rounds presentations, and didactic lectures with health care providers at multiple federally qualified health centers. Studies with eligibility criteria favorable to minority patients were opened. An anonymous, 5-minute survey was conducted at regular visits with Smilow Breast Center patients to gauge awareness of and access to CT. The survey was performed on iPads with the Qualtrics application in English or Spanish. Survey data were compared to the Yale Cancer Center Clinical Trials Office, Connecticut Tumor Registry, and U.S. Census records. Two-tailed Fisher's exact tests were used for all analysis. Results: In Sept. 2015, only 11% of 98 CT participants were minorities even though minorities accounted for 17% of breast cancer incidence in New Haven County and 16% in Connecticut. By Sept. 2017, 22% of 89 were minorities, p=0.049. Survey results confirmed a reduction in the disparity: 162 patients were asked to take the survey—12 declined, and 150 completed it. The ethnic/racial breakdown of the participants was as follows: 69% White, 10% Black, 9% Hispanic/ Latino, 3% Asian, and 9% unknown; this is in line with both the Connecticut Tumor Registry data and expected incidence based on the 2010 U.S. census. The percentage of patients invited to participate in CT and the percentage of offers declined were as follows: invited 41%, declined 19% (White); 60%, 33% (Black); 29%, 0% (Hispanic/ Latino); 25%, 0% (Asian); and 36%, 0% (unknown). There were no significant differences in invitation or decline rates between White and minority patients or between individual racial/ethnic groups. Black and Hispanic/Latino patients were significantly less likely than White patients to be aware of CT prior to the survey with only 58% confirming prior knowledge compared to 95% of white patients, p &amp;lt;.01. Conclusions: Efforts to increase minority participation in CT through institutional and community engagement were successful. Patient education regarding CT should be increased for minority patients. This approach will be used with other disease types at the Yale Cancer Center. Citation Format: Amelia A. Trant, Lucas Walz, Whitney Allen, Hannah Verma, Mindy Le, Jose DeJesus, Christos Hatzis, Andrea Silber. Addressing both community and institutional barriers increases accrual of minority patients in breast cancer clinical trials [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A089.

The Effect of Discrimination on Likelihood of Participation in a Clinical Trial.

Despite efforts to increase minority enrollment in research, racial disparities still exist, and a belief persists that minorities are inherently less likely to enroll in medical research. This lingering view may impact the manner in which studies are presented to minority patients. This study aimed to assess racial differences in reported discrimination while seeking medical care and likelihood to participate in a medical research study. 844 residents were enrolled via convenience sampling, and asked to complete a survey designed to examine perceived discrimination while seeking healthcare and likelihood to participate (LoP) in a medical research study. Participants who reported worse treatment than other races had lower mean LoP scores (53.7 ± 17.6) than participants who reported being treated the same as (61.1 ± 16.1) or better than (64.0 ± 15.0) other races (p < .001). There were no significant differences in mean LoP score by race/ethnicity. The interaction of race with discrimination had no significant effect on mean LoP (p = 0.8). There was a statistically significant association between race and discrimination (X2 = 11.32, p = 0.023), although the majority of participants reported no discrimination. Patient experiences in the medical arena may have an impact on their willingness to join a medical study. An effective strategy to increase minority participation in research may be to work with investigators and staff on implicit bias with regard to minority patients. Further research should focus on the impact of research staff interactions on an individual's decision-making process.

STRATEGIES TO INCREASE MINORITY PARTICIPATION IN A HEALTHY AGING AND NEIGHBORHOOD STUDY

Adequate minority participation is critical to health disparity research. Conventional direct mails are less effective in minority recruitment. The Healthy Aging and Neighborhood Study developed a multifaceted, community-engaged, culturally and linguistically appropriate method to recruit community-living older adults (≥65y) in Worcester County, Massachusetts. The research team is bilingual, racially and culturally diverse. A direct mail campaign was conducted in a geographically diverse random sample of residents from neighborhoods with high concentrations of minorities, stratified by rurality. To increase minority participation, the mailings included an invitational letter or a flyer with a graphic that portrays diverse racial/ethnic background. We engaged communities by presenting the study at senior and community centers, and faith-based organizations that are frequented by minorities and by posting study information in minority social media groups (e.g., Chinese resident associations). Participants promoted the study to friends while staff promoted through professional or social networks. To recruit non-English speaking minorities, all materials were printed in age-friendly large fonts in Spanish or Chinese, and interviews were conducted using their preferred language. Within 9 months, we enrolled 326 participants, including 216 Whites, 57 Hispanics, 21 Blacks, 31 Asians, and 1 Native American. An additional 38 Asians are on the waiting list. Blacks were more likely to respond to community presentations. Hispanics were most likely to respond to the colorful flyer. Older minorities (>76y) were more likely to respond to presentations (57%) while the younger (<75y) to the mailings (60%). In summary, this multifaceted recruitment approach is effective in minority recruitment.

Barriers to minority recruitment in a multicenter clinical trial (PRO-TECT [AFT-39]): Research staff insights.

145 Background: Rates of minority enrollment in U.S. cancer clinical trials, including supportive care trials, are disproportionately low. Clinical research associates (CRAs) are the linchpin for successful accrual and often help screen and approach patients to discuss research studies. We sought to understand clinic-level factors that influence recruitment of African American patients (AA) in an ongoing U.S. multicenter, cluster- randomized controlled trial (PRO-TECT: Patient-Reported Outcomes to Enhance Cancer Treatment; NCT03249090 AFT-39]). Notably, partway through this trial, a purposeful enrollment strategy was initiated where sites were asked to focus on minority recruitment. Methods: A subset of community oncology practices participating in PRO-TECT was identified with: 1) overall patient populations ≥20% AA; or 2) &lt;20% AA but trial enrollment ≥20% AA. Semi-structured phone interviews were conducted with CRAs at each site to elicit perceived barriers and facilitators in identifying and approaching AA patients for this trial. Results: Among 13 identified community practices out of a potential 50 randomized sites, 3 had populations &lt;20% AA but enrollment &gt;20% AA; 3 had populations ≥20% AA but enrollment &lt;20% AA; and 7 had populations ≥20% AA and enrollment &gt;20% AA. All sites identified participants through review of clinic visit lists with clinicians. Eleven out of 13 sites felt they experienced no barriers to identifying, approaching, or enrolling minority patients. One site CRA felt minority patients are often “too sick to participate”. One CRA felt awkward about the request to purposefully approach minority patients. Conclusions: Site CRAs generally did not perceive barriers to minority recruitment, even when their population demographics were underrepresented in accrual. Results of efforts in this trial to increase minority participation through a purposeful enrollment strategy will be reported elsewhere.

Risk of Cancer Death Among White, Black, and Hispanic Populations in South Florida.

BackgroundThe cancer burden in South Florida, with a population of more than 6 million with a heavily Hispanic and large Afro-Caribbean population, has not been quantified.MethodsWe analyzed 2012–2016 cancer mortality data from South Florida for white, Hispanic, and black populations with disaggregation for Cuban, Puerto Rican, South American, African American, and Afro-Caribbean groups. We calculated cancer site-specific and all-sites combined age-adjusted mortality rates, and we used negative binomial regression to determine mortality rate ratios to compare South Florida’s cancer mortality rates with those of the rest of the nation.ResultsWe analyzed 53,837 cancer deaths. Per 100,000 population, cancer mortality rates in South Florida were similar among white (173 per 100,000) and black (176 per 100,000) men and among white and black women (133 for both), and they were lowest among Hispanic men (151 per 100,000) and women (93 per 100,000). However, compared with their counterparts nationally, Hispanic residents in South Florida had higher cancer mortality rates, largely driven by Cuban residents, and mortality rates among white and black residents, especially male residents, were substantially lower. Liver cancer rates were high among white and Puerto Rican “baby boomers”; lung cancer mortality was low among all groups except Cuban men; cervical cancer was high among white, black, and Puerto Rican women.ConclusionCancer patterns are not monochromatic in all US regions; South Florida is distinctive. Meeting the needs of an aging diverse population presents challenges for all major metropolitan areas. Expanding surveillance, increasing minority participation in clinical trials, and investing in culturally specific community-based health promotion must continue.

This Story Needs to Be Told: Formative Research on Using Animated Storytelling to Address Prospective Minority Clinical Trials Participants’ Need for Comprehensive Knowledge

Background: The Komen Tissue Bank (KTB), a clinical trial that collects women’s healthy breast tissue for use as research study controls, currently stores samples demonstrating a noted paucity of minority specimens. Studies have shown minority groups’ participation in clinical trials is dependent upon the groups’ knowledge about the associated research. This study’s purpose is to conduct formative research on animated storytelling’s effectiveness as a communication tool to address minority groups’ expressed need for knowledge and encourage participation in cancer clinical trials. &#x0D; Methods: I re-coded data previously gathered from a KTB study to evaluate the perceptions of Latinas (n=14) and Asian Americans (n=17) toward breast tissue donation. Extensive review of the current literature yielded data concerning African Americans’ outlooks toward clinical trial participation, and also illustrated the efficacy of using narratives and animation as communication and education tools. &#x0D; Results: The literature review clearly illuminated the importance of storytelling in minority cultures and suggested the success of using narratives as communication tools. We anticipate our findings could be influenced by a) minorities’ lack of, and need for, comprehensive knowledge, b) previously obscured participation barriers, and c) animated storytelling as an effective delivery method. &#x0D; Projected Conclusion and Potential Impact: Using an animated storytelling communication tool may successfully increase knowledge about, and comfort with, participation in a cancer clinical trial. The next phase, an animated video production, will tell the comprehensive story of healthy breast tissue donation. The use of this tool could help increase minority participation in cancer prevention and cancer clinical trials.

Learning and Action in Community Health: Using the Health Belief Model to Assess and Educate African American Community Residents about Participation in Clinical Research

The Learning and Action in Community Health project was implemented to gather preliminary data needed to inform community-engaged educational approaches to increase clinical research participation among racial minorities. The Health Belief Model was the theoretical framework utilized to develop the intervention and assessment tools. An educational session about clinical research and biorepository participation was designed using clinicaltrials.gov information and administered to adult, African American community residents (n = 60) in Atlanta, Georgia. Pre- and post-tests were collected and analyzed to assess changes in participants’ knowledge, perceptions, and willingness to participate in clinical studies and biorepositories. There were statistically significant changes in knowledge about joining a clinical study (p < 0.001) and registry or biorepository (p < 0.001). There was no statistically significant change in willingness to participate in clinical research or biorepositories after the educational session. Focus groups were conducted to gather feedback on the educational session and perceived barriers and benefits to participating in clinical research. Perceived benefits were improving health, receiving incentives, early detection of health issues, and access to care. Perceived barriers included fear, lack of knowledge, historical mistrust of research, and time constraints. Results have implications for subsequent community-engaged approaches to increasing minority participation in clinical research.

Abstract A25: Community research navigators: The bridge to increasing ethnic minority participation in clinical research

Abstract The participation of underserved ethnic minorities in clinical research is critical to achieving progress in cancer control. Ethnic minority patient accrual in clinical trials is a formidable challenge that requires patient trust, commitment, and overcoming of barriers. Racial and ethnic minorities make up about 40% of the United States population, yet are not well represented in research studies. Less than 10% of all patients with cancer enrolled in clinical trials are minorities. Diverse participation may lead to more generalizable results for under-represented groups, more best practices for prevention and treatment to specific minority groups, increase in knowledge and awareness of disparities about cancer, and a more accurate reflection of the United States' increasingly diverse population. Although there is a proliferation of patient navigation programs to increase health care among the underserved, there is little known on its potential effects as a strategy to enhance minority clinical trial and biospecimen accrual. City of Hope has built a functional and sustainable program for addressing health inequity, which includes training a network of community research navigators (CRN) to address gaps in knowledge, medical mistrust, and access, and navigate participation and engagement of under-represented groups in research. The research navigator program draws from the patient navigation and promotora model and is a novel and innovative application to this approach. This approach has utility and applicability to address research participation barriers, including trust and referrals. It promises sustainability and cost effectiveness as trained CRNs can deliver the program. The Community Research Navigator (CRN) project enhances community advocates' capacity by training community health leaders/promotoras as community research navigators (CRN) to widen the dissemination of the clinical trial and research participation enrollment for increased ethnic minority participation in clinical trials and health-related research. CRNs attended a 1-day training on clinical trials and research. The training included educating and encouraging individuals to proactively think about and discuss clinical trial participation with their family, friends, and health care providers; disseminating information about specific research studies, targeting the African and Latino communities; and referring individuals to specific biospecimen, clinical trials, and population studies. In total, we trained and mentored a team of 14 CRNs. Participants were 24-66 years old; most were female (86%), Latino (69%), and single (43%). After participating in the training, participants were more likely to correctly define HIPAA (p=.040) and the types of clinical trials (p=.038). In addition, CRNs were more likely to encourage clinical research participation among their family after the training (p=0.034). Further, we measured confidence in various domains, including: increase in confidence in describing the purpose and process of clinical research (p=0.006); educating minority communities about clinical trials (p=0.045); and providing informational workshops/forums on clinical research (p=0.046). Participants had an increase in overall confidence (p=.033). Our findings demonstrate that the CRN strategy holds promise in increasing minority participation in cancer clinical trials. It is an innovative application of the extensively studied patient navigation approach that warrants research. Future research should focus on the CRN project as a cost-effective tool for enrollment and retention of ethnic minorities in cancer clinical trials and the potential of enhancing clinical trial understanding outcomes among participants. Citation Format: Marisela Garcia, Mayra Serrano, Alejandro Fernandez, Katty Nerio, Kimlin Ashing. Community research navigators: The bridge to increasing ethnic minority participation in clinical research [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A25.

Bridging the Gap: Racial concordance as a strategy to increase African American participation in breast cancer research.

Lack of African American females in breast cancer research has been receiving substantial attention. This study seeks to identify research perceptions and motivating factors needed to increase racial/ethnic minority participation in breast cancer research. A total of 57 African American women (Σ = 47.8 years), from Rhode Island and Texas, completed a questionnaire and focus group. While many participants were not breast cancer survivors, they reported knowledge of their racial group's risk for breast cancer. One major finding that could be seen as both a facilitator and barrier is racial concordance between participant and researcher. Cultural sensitivity and trust building is recommended to increase minority participation.

Apoyo con Cariño: Strategies to Promote Recruiting, Enrolling, and Retaining Latinos in a Cancer Clinical Trial

Background: We present and describe tailored strategies to address known barriers to minority participation in clinical trial research. The strategies used allowed our team to engage communities and successfully recruit, enroll, and retain a diverse underserved population of Latinos with advanced cancer for this clinical trial. Methods: Participants were recruited from 3 urban and 7 rural sites. We identified 4 critical barriers to recruitment for this underserved population: (1) mistrust; (2) language and communication barriers; (3) lack of access to academic cancer center; and (4) inability to participate due to transportation, childcare, or work responsibilities. We developed tailored strategies to engage referring sites and patients to participate in the clinical trial. Results: We identified 318 potentially eligible participants; 34 were found to be ineligible, and 223 consented to participate in the study, representing a 79.0% enrollment rate. All patients (100%) self-identified as Latino, and 47.5% spoke Spanish as their primary language. Patients were socioeconomically disadvantaged: 53.6% had an annual income <$15,000 USD, and 50.2% had less than a high school education. A total of 177 participants completed the 3-month follow-up; 26 died before the 3-month follow interview, and 20 did not complete the follow-up evaluation (9% withdrawal rate). Conclusions: Our community-informed strategies were highly effective for recruiting, enrolling, and retaining an underserved diverse population of Latinos. The barriers we identified and the strategies we used have the potential to inform research to increase minority participation in cancer clinical trials. ClinicalTrials.gov identifier: NCT01695382.

Minority Representation in Migraine Treatment Trials.

Minorities have historically been underrepresented in clinical research trials despite having comparatively poor health indicators. Recognizing the dual inequalities of increased disease burden and decreased research participation, the National Institute of Health (NIH) Revitalization Act of 1993 mandated the inclusion and reporting of women and minorities in NIH-funded research. While progress has been made in the subsequent decades, this underrepresentation of minorities in research trials persists and has been documented in multiple disciplines. However, the extent of adequate representation and reporting of minority inclusion in clinical trials for migraine remains unknown. In this systematic review and study, we review the literature examining the representation of women and minorities in migraine clinical research trials METHODS: First we searched PubMed for pertinent articles examining the inclusion of women and minorities in migraine clinical research trials. Second, we identified controlled-trials for migraine published since 2011 in major neurology, headache, and general medicine journals using the terms "migraine randomized controlled trial." We then reviewed the results manually and excluded pilot studies and those with fewer than 50 participants. We next determined (a) how frequently representation of minorities and women were reported in these major trials; (b) what factors correlated with reporting; and (c) whether women and minority inclusion comprised their ratios in the general population. We identified 128 relevant clinical trials, of which 36 met our inclusion criteria. All 36 trials (100%) reported gender frequency, and 25 of 36 (69.4%) reported ethnicity or race. Among all studies, women and Whites represented 84.2 and 82.9% of participants (mean), respectively. Studies conducted in the United States and funded by a private company were more likely to report race than studies conducted exclusively outside of the U.S. or with a public sponsor. No studies stratified efficacy or safety by ethnicity or gender. Men and non-Whites in the U.S. were statistically underrepresented. Most recent headache studies comply with the NIH mandate to include women and minorities in research trials, particularly U.S.-based and industry-funded studies. Whites are overrepresented compared to both the general population and the population of migraineurs. Future studies should strive to increase minority participation and investigate race-based differences in migraine expression, treatment response, and medication toxicity.