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.

Mobile devices including phones offer significant contributions to improve reach and convenience of research participation and data collection. Technological advancements have enabled smartphone devices to track health behaviors such as physical activity and provide convenient feedback as well as survey data. High usage of mobile devices i.e., smartphones among both US born and immigrant Latinos may not similarly translate to mobile technology utility for research participation among Latinos and other ethnic minority populations. Among Latinos, smartphones are primarily used for communication as only 50% use the data application capabilities. The acceptability and application of mobile data harnessing tools can present both opportunities and challenges for engaging this population in research. We report our observations of the challenges Latinas face using mobile technology for data collection. Latina mothers were recruited from school to participate in a behavioral nutrition and physical activity study for cancer and chronic disease reduction. A total of 38 enrolled and 32 participated in the intervention. 63% were Spanish speakers, 59% were foreign-born, 66% had ≤high school education, 91% reported income <$40,000. Participants used a mobile device to perform two tasks: 1) complete a REDCap online survey on a tablet and 2) download and install a fitness tracker mobile application. Latinas rated their confidence in their ability to use mobile technology using a 4- point Likert scale. Participants with little/no confidence requested paper versions of the survey. 88% required individualized research staff assistance to complete the survey and set-up their fitness tracker. Monolingual Spanish-speakers were more likely to report little/no confidence connecting to Wi-Fi (χ2=13.175, p<0.01), downloading an app (χ2=11.277, p=0.01), creating an electronic account (χ2=7.882, p<0.05). Our findings suggest that lower-income, Spanish-speakers require more assistance and ongoing guidance with technology applications and devices for research data collection. In fact, we found that about 20% shared the device (Fitbit) with family members, especially children to facilitate the participants' use of the device. However, this threatened data accuracy. Therefore, studies using mobile technology should account for the added staffing and resources required to conduct studies with this population. Addressing this barrier may require a pre-study session to train research participants on the study's technology applications. Further research is needed to evaluate and improve the applicability of mobile technology for increasing reach and participation, as well as validation of data accuracy for medically underserved and understudied populations. Citation Format: Kimlin T. Ashing, Alejandro Fernandez, Mayra Serrano, Marisela Garcia, Katty Nerio. Challenges and opportunities using mobile technology for data collection in biomedical research: An observational discovery science investigation with Spanish-speaking Latinas [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 5287.

Despite cancer being the leading cause of death across most racial/ethnic groups, Hispanic women have the second highest mortality rate attributed to diabetes (4.7%) according to the Centers for Disease Control and Prevention (CDC). While cancer and diabetes are two distinct diseases, previous studies have demonstrated that diabetic women have a poor chance of breast cancer survival when compared to nondiabetic women. Well-known key drivers of hyperinsulinemia and insulin resistance, such as insulin and AMPK, are also those involved in breast cancer. This link could possibly contribute to the increased mitogenic effects and risk for aggressive breast cancers in Hispanic women. Based on these findings, metformin, a drug standardly used to treat and prevent hyperglycemia, may be a possible alternative (other than tamoxifen) for breast cancer prevention. Eat, Move, Live (EML), a 5-week community-based program, focuses on targeting possible treatments of chronic diseases and risk reduction through attitude and lifestyle modifications. Exercise, nutritional and health awareness classes were implemented to change participants' perspectives regarding chronic diseases and their susceptibility to other morbidities. Questionnaires were given to the participants at baseline and at two follow-ups (5 weeks and 12 weeks) to assess any changes in their attitudes, behaviors, nutrition, lifestyle and beliefs around taking medication for preventative treatments. A total of 56 participants' pretreatment responses were collected via a five-point Likert scale (1-strongly disagree, 5-strongly agree). Demographic data showed that 69% of the respondents were Hispanic women, of whom 46% completed an education level of high school or less. A majority of the responses averaged a “neutral” response to taking medication for management and prevention of diabetes. We infer that their inability to select a stance in their responses may be associated with the lack of knowledge that the community has regarding chronic diseases and risk-prevention methods. Therefore, we anticipate that availability of proper education tools and resources is essential to potentially prevent future morbidities and mortalities. Ultimately, we aim to establish a pilot study that emphasizes the necessity and importance of interventional programs, like EML, to enhance chemoprevention using metformin and improve health outcomes in high-risk breast cancer populations. Citation Format: Mayra Serrano, Angelica Sanchez, Christine Thai, Katty Nerio, Cristal Resto, Marisela Garcia, Tanya A. Chavez, Laura L. Kruper, Veronica C. Jones, Lisa D. Yee, Alan Nuñez, Ellen J. Rippberger, Angela K. Wong, Noé R. Chávez, Karen Herold, Chidimma M.K. Kalu, Jackelyn A. Alva-Ornelas, Jerneja Tomsic, Krista M. Round, Regina Agulto, Margarita Robles, Ombeni M. Idassi, Kendall J. Kennedy, Christopher Sistrunk, Victoria L. Seewaldt. Receptiveness of metformin as a breast cancer prevention drug within the Hispanic community [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 B119.

Racial and ethnic minority groups experience diet-related disparities and as a result tend to have poorer nutrient dense dietary consumption. Dietary intake lacking nutrient dense foods has been associated with higher risk of cancer. Key contributors to diet-related disparities include environmental factors such as perceived barriers toward healthy eating. The Eat, Move, Live (EML) program seeks to increase participants’ knowledge, attitudes, and behaviors regarding nutrition and healthy eating habits. The purpose of this study is to examine the changes in perceived barriers to healthy eating following the completion of a community-based intervention strategy. Participants of the program attended either a 5-week or 12-week series of courses which included: a one-hour interactive nutritional education segment, a 30-minute food preparation followed by a demonstration, and 30-minute physical activity session. Each of the segments sought to address topics aimed at reducing the prevalence of cancer. Health behaviors, beliefs, and demographics were obtained utilizing a self-administered questionnaire. Body measurements and biomarkers were taken at baseline and at follow-up. A total of 93 participants completed the self-administered questionnaire. The population was made up primarily of females (83%); 52% were monolingual English speakers, 33% were monolingual Spanish speakers, 13% were Bilingual (English & Spanish), and 2% specified other. 71% of participants had a household income less than $24,000/year and 30% had less than a high school education. Changes in perceived barriers to healthy eating were examined and there were statistically significant variations among 4 of the 13 reported barriers to healthy eating questions. When asked if it was difficult to eat healthy pre-intervention 39 of the 64 participants marked yes, but post-intervention only 26 of 64 marked yes (p<.002). Pre-intervention 22 of 40 stated that they did not know how to prepare healthy meals and post-intervention only 11 of 40(p<.003).This study demonstrated that a tailored community-based intervention strategy can significantly reduce the perception of barriers to healthy eating, which has been linked to a reduction in cancer. EML was shown to increase participants’ knowledge, attitudes, and behaviors about nutrition and eating habits. Citation Format: Katty Nerio, Cristal Resto, Marisela Garcia, Alejandro Fernandez, Mayra Serrano. Eat, move, live: A community-based intervention strategy aimed at reducing the perceived barriers toward healthy eating through tailored modifications in lifestyle and nutrition [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr D023.

The recruitment of ethnic minorities into clinical trials is a formidable challenge. African-Americans make up 12% of the U.S. population but only 5% of clinical trial participation. There is an even larger disparity in the Latino population. Latinos make up 18% of the U.S. population and only account for 1% of clinical trial participants. Research efforts to address ethnic minority underrepresentation in research is required for broad population scientific applicability and advancement. For example, nearly 1/5 of new drugs reviewed by the FDA showed racial/ethnic differences in drug disposition and response. Therefore, investigating the barriers of minority participation in research is imperative. Currently, there is a wealth of knowledge on barriers to participation from the patient’s or physician’s perspective. However, there is a dearth of information investigating the barriers to minority participation from perspective of research professionals who conduct the recruitment for studies. Clinical research staff at City of Hope were surveyed to gather information about barriers to the recruitment of minority and underrepresented populations into clinical trials. We developed a pilot survey of 52 questions to be answered by clinical research associates, coordinators and nurses. The pilot survey was distributed via a listserv in the Department of Population Sciences. The survey gathered demographics, types of clinical trials offered and barriers to minority enrollment. A total of 27 research staff completed the survey. The average age of the respondents was 31, most (85%) were female, Latino (52%) and single (56%). Fifteen percent of respondents were not willing to participate in research. The majority (78%) reported experience working with patients from minority and underserved populations, although (52%) said they did not currently target the recruitment of racial and ethnic minorities. The majority (52%) also said they do not target the recruitment of women and vast majority (78%) do not currently target the recruitment of sexual and gender minorities. Of those that reporting targeting the recruitment of minorities, most (100%) target Latinos, African Americans (62%), and Asians (54%). Most (52%) reported that recruitment entails extra work for the physician, 48% reported that language is a barrier to enrolling patients into trials and 33% reported insurance disqualification as a barrier. Findings suggest that even though research staff report working with these targeted populations, there are missed opportunities to accrue them to clinical trials. We plan on building upon this pilot by expanding the survey outside of Population Sciences to include all research staff at City of Hope. This will also include the addition of key informant interviews to further explore how the cancer center infrastructure can help facilitate the recruitment of minorities. This will allow us to examine systemic barriers and facilitators to clinical trial recruitment. Citation Format: Mayra Serrano, Alejandro Fernandez, Marisela Garcia, Katty Nerio, Rick Kittles. Defining the current state of minority recruitment into clinical trials: Perspectives of cancer center research staff [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-071.