Minorities In Cancer Clinical Trials Research Articles

Using an AI trial screening tool to assess language as a barrier for enrollment of underrepresented minorities in cancer clinical trials.

e13586 Background: A major limitation of clinical trials is limited generalizability due to low enrollment of underrepresented minorities (URM). The percentage of patients who are non-English speaking (NES) is higher in URM and language barriers may discourage providers to offer participation in clinical trials. We have developed an artificial intelligence-based system to identify patients eligible for clinical trials, Clinical Trials Patient Matching (CTPM). This platform offers an ideal opportunity to explore bias in enrolling patients on clinical trials (CT). Among patients identified by CTPM as eligible for CT we assessed the impact of NES on trial enrollment. Methods: Individual algorithms were constructed within CTPM to identify patients potentially eligible for two trials open at Yale Cancer Center, DARE (NCT04567420) and EMBER-4 (NCT05514054). Eligibility was confirmed by Clinical Trials Office staff and notification of eligibility was communicated to the treating provider. Retrospectively, we evaluated the impact of NES status on clinical trial enrollment. This analysis occurred between 9/1/2022 and 11/30/2023 and all study-related activities were approved by the Yale IRB. Results: Out of the 13,466 unique patients presenting to the Yale Cancer Center and Smilow Cancer Network breast program within the period of study, 5.1% were NES and 94.9% were English speaking (ES). Of the patients identified by CTPM as eligible for the 2 clinical trials 7.9% were NES and 92.14% were ES. However, out of patients enrolled, only 1.59% were NES and 98.41% were ES. For the DARE trial, enrollment rate was 38.3% for ES vs 0% for NES (p=0.0081). For the EMBER4 trial, enrollment was 13.4% for ES vs 14.3% for NES (p=1.0). The aggregate data for both trials revealed an enrollment rate of 29.4% for ES vs 5.6% for NES (p=0.0285). Conclusions: We found that patients who identify as NES were less likely to be enrolled in cancer clinical trials. CTPM appears to be an effective tool to prospectively identify underrepresented populations in clinical trials and serve as a platform for developing interventions to address disparities in trial participation, including language. [Table: see text]

The imprecise promise of the Precision Medicine Initiative (PMI): Where we got it wrong and how can we fix it?

e15102 Background: Over the last several years, science has taken strides in how we understand and treat cancer. We have learned that each person’s cancer is unique, in part because it is influenced by a patient’s biological characteristics, environmental exposures, lifestyle and epigenetic influence. There is excitement about the potential of PMI to transform healthcare delivery and improve population health. Targeted therapies developed based on specific mutations can result in improved outcomes and reduced toxicities. Limited knowledge of cancer biology and the genomic underpinnings of cancer in racial and ethnic minorities diminishes the potential of PMI. Previous efforts of obtaining biospecimens from institutional or local biobanks presents a challenge of inadequate representation of racial and ethnic diversity. This can result in exacerbation in the therapies efficaciousness. Methods: Numerous research studies have surfaced indicating that PMI has resulted in widening racial and ethnic health care disparities since state-of-the art diagnostic and treatment options are unequally distributed across the entire cancer population. A literature review highlighted the racial inequalities and disparities. Results: A report examining the racial diversity of samples in TCGA found that whites were overrepresented in the U.S. population while Asian and Hispanic patients were underrepresented at a 5 percent frequency. In the BATTLE study, 82 percent of participants were white, and only 6% were African American (AA). The NCI-MATCH trial preliminary numbers show that AAs accounted for about 10 percent of patients. Therefore, it should not be assumed that the response rates or clinical effectiveness of the therapeutics tested in these trials will generalize to all racial and ethnic groups. The underrepresentation of racial and ethnic minorities in cancer clinical trials and prevention research, along with the documented challenges to enrolling these individuals into studies pose a barrier for the implementation of precision medicine in these populations. Collectively, these challenges can slow the pace of medical innovation, decrease the generalizability of research findings, lead to incorrect interpretations, and limit our full understanding of precision medicine. Conclusions: It is imperative we develop solutions to solve for issues identified related to precision medicine testing and treatment development. We have developed a framework to address disparities in PMI through community-based initiatives. A two-step solution could be considered to address this unmet need. Through the development of a registry and biospecimen banking as well as just in time trials that include pharmacogenomics, we can follow the patient journey to identify unique characteristics by race and/or socioeconomic status to begin solving for the disparities across the population.

Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials.

152 Background: Extensive attention has been paid in recent years to the possibility that bias among health care professionals contributes to health disparities. In its 2003 report, Unequal Treatment, the Institute of Medicine concluded that bias against racial minorities may affect communication or care offered. However, the role of bias in the context of recruitment of racial minorities in cancer clinical trials has not been explored. Therefore, we assessed clinical and research personnel’s experiences related to factors influencing recruitment of racial and ethnic minorities for cancer clinical trials. Methods: Ninety-one qualitative interviews were conducted at 5 U.S. cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, referring clinicians and research staff. Data analysis was conducted using a content analysis approach to generate themes from the transcribed interviews. Results: Five prominent themes emerged. 1) Recruitment interactions with potential minority participants were perceived to be challenging. 2) Potential minority participants were not perceived to be ideal study candidates. 3) A combination of clinic level barriers and negative perceptions of minority study participants led to providers withholding clinical trial opportunities from potential minority participants. 4) When clinical trial recruitment practices were tailored to minority patients, addressing research misconceptions to build trust was a common strategy. 5) For some respondents, race was perceived as irrelevant when screening and recruiting potential minority participants for clinical trials. Conclusions: Not only did some respondents view racial and ethnic minorities as less promising participants, some respondents reported withholding trial opportunities to minorities based on these perceptions. Some providers endorsed using tailored recruitment strategies while others eschewed race as a factor in trial recruitment. The presence of bias and stereotyping among clinical and research professionals recruiting for cancer clinical trials, should be considered when designing interventions to increase minority enrollment.

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.

Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

A Review of Barriers to Minorities' Participation in Cancer Clinical Trials: Implications for Future Cancer Research.

To enhance nurses' awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities' participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities' participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses' competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care.

Strategies of persuasion in offers to participate in cancer clinical trials I: Topic placement and topic framing.

Clinical trials are the gold standard in medical research evaluating new treatments in cancer care; however, in the United States, too few patients enroll in trials, especially patients from minority groups. Offering patients the option of a clinical trial is an ethically-charged communicative event for oncologists. One particularly vexed ethical issue is the use of persuasion in trial offers. Based on a corpus of 22 oncology encounters with Caucasian-American (n = 11) and African-American (n = 11) patients, this discourse analysis describes oncologists' use of two persuasive strategies related to the linguistic structure of trial offers: topic placement and topic framing. Findings are presented in total and by patient race, and discussed in terms of whether these strategies may constitute ethical or unethical persuasion, particularly with respect to the ethical issue of undue influence and the social issue of underrepresentation of minorities in cancer clinical trials.

Abstract A71: Clinical trial participation: Differences in distance traveled across different ethnic groups

Abstract Background: Latinos and African Americans make up a significant portion of the U.S. population, and face either high prevalence and/or high morbidity related to cancer compared to Whites but cancer clinical trial participation rates continue to be low. Multiple barriers have been identified including travel distance but little work has assessed differences between ethnic groups. The purpose of this analysis was to examine the distance between participants' home zip codes and the Radiation Therapy Oncology Group (RTOG) site where they participated in a clinical trial and look for differences between types of sites and racial/ethnic identification. Methods: Data was obtained from RTOG, including zip codes of RTOG full and affiliate members and their satellite sites along with Community Clinical Oncology Program (CCOP) members. In addition, patient accrual to all RTOG clinical trials per site over the period of 2006-2009 was collected. Patient data collected included zip code, race, and ethnicity only. Only patients with complete data were included. Racial/ethnic categories included Latino, African American, and other. The other category included 96% Whites and was subsequently labeled Whites. No additional identifiers were collected. Next the distance (direct distance in miles) was calculated between the centroid of the U.S. postal zip codes of all individual patients and the RTOG site address where the patient was accrued. Descriptive statistics were calculated for distance traveled for the different types of sites and the three ethnic categories (African American, Latino and White). Results: Of the total sample size of 6168 patients, 80% had complete information and were included in the analysis. 4072 were treated at full/affiliate site and 841 at a CCOP site. Of those patients who participated in a full or affiliate site, 11% were African American and 4.1% were Latino with the remainder being White. Similarly of those who participated at a CCOP site, 11.4% were African American and were 4.5% Latino. Concerning distance traveled to different types of sites, travel to full/affiliate membership sites was greatest for Whites (median 13.4 miles) and least for African Americans (median 5.75 miles). Whites and Latinos traveled a significant greater distance to a Full/Affiliate sites compared to a community sites (p<0.0001 and p=.01 respectively) whereas African American's travel distance to Full/Affiliate or community sites was not significantly different (p=0.60). Per post hoc analysis, White patients traveled significant longer than African American or Latinos patients to community sites (p<0.0001, p=0.001, respectively). For full/affiliate sites (non-community), African Americans traveled a significantly shorter distance when compared to Latinos or Whites (p<0.0001 for both). Conclusion: Distance traveled to participate in clinical trials is an area which requires consideration especially in radiation treatment trials. Different racial/ethnic groups experience different travel burden sometimes based on where they live. For urban dwellers, factors such as public and private transportation options including access to private car, bus and rail routes, bus and rail stops, transfers, walk times and wait times are important to consider in addition to distance. For rural residents, distance traveled and economic factors, such as gas prices are important. With a greater understanding of travel burden for clinical trial participants, we can alter outreach efforts to include more minorities in cancer clinical trials to help improve treatment outcomes. (This study was supported by the Pennsylvania Commonwealth Universal Research Enhancement (C.U.R.E.) Program ME-02-149, RTOG U10 CA21661 and CCOP U10 CA37422 grants from the NCI.) Citation Format: Katherine A. Yeager, Jesse Bruner, Stephanie L. Pugh, Deborah Watkins Bruner. Clinical trial participation: Differences in distance traveled across different ethnic groups. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A71. doi:10.1158/1538-7755.DISP13-A71

The Development of a Minority Recruitment Plan for Cancer Clinical Trials.

Cancer does not occur in all ethnic and racial groups at similar rates. In addition, responses to treatment also vary in certain ethnic and racial groups. For Hispanics, the overall cancer incidence is generally lower yet for some specific tumor types, the incidence rates are higher compared to other populations. Although disparities are recognized for treatment outcomes and prevention methodologies for Hispanics and other minority populations, specific recruiting and reporting of minorities remains a challenge. In order to circumvent this problem, the Cancer Therapy and Research Center (CTRC) has developed a new minority recruitment plan for all cancer related clinical trials at this Institute. The overall goal of this initiative is to increase the accrual of minorities in cancer clinical trials by implementing several key interventions. The Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center at San Antonio established the Clinical Trials Accrual Task Force to develop and monitor interventions designed to increase accrual to cancer clinical trials, specifically the accrual of minorities with a focus on the Hispanic population that makes up 68% of the CTRC's catchment area. A Minority Accrual Plan (MAP) was implemented in March 2013 as part of the process for initiating and conducting cancer-related clinical trials at the CTRC. The Minority Accrual Plan focuses on Hispanic enrollment due to the characteristics of the South Texas population served by the CTRC but could be easily adapted to other populations. The CTRC has designed a process to prospectively address the challenge of deliberately enrolling minority subjects and accurately accounting for the results by implementing a Minority Accrual Plan for every cancer-related clinical trial at CTRC.

Psychosocial Barriers Contributing to the Under-Representation of Racial/Ethnic Minorities in Cancer Clinical Trials

ABSTRACT Various psychosocial barriers currently prevent proportional representation of racial and ethnic minority groups in oncology clinical trials. These barriers can be conceptualized into a Social Ecological Model framework, with particular emphasis on the socio-cultural dimension. The barriers to participation can be summarized into six levels of influence: intrapersonal, interpersonal, environmental, socio-cultural, community, and institutional. Given social workers' multi-systemic approach to assessing and intervening in problems, their positioning at micro-, meso-, and macro-levels of practice, education, policy, and research are appropriate and critical to promoting clinical trial participation.

Physician Perspectives on Increasing Minorities in Cancer Clinical Trials: An Eastern Cooperative Oncology Group (ECOG) Initiative

PURPOSE: This paper describes the ECOG-NMA Minority Accrual Initiative to assure minority participation in cancer clinical trials. METHODS: Focus groups were held to identify physician-reported barriers to the enrollment of minority patients in Cleveland, OH, Indianapolis, IN, Santa Clara County, CA, and Philadelphia, PA. Community physicians affiliated with the National Medical Association (NMA), and Eastern Cooperative Oncology Group (ECOG) investigators participated in the focus groups. A four-step process consisting of focus group workshops were conducted to (i) identify barriers, (ii) develop potential solutions to the barriers, (iii) define solutions to barriers involving specific clinical trials, and (iv) implement the solutions. RESULTS: Focus group participants identified physician lack of information, patient fears and suspicion, the fear of losing patients, and distrust of the health care system as the major barriers to enrollment of African Americans. We found significant differences between community physicians and cancer program physicians in several areas. Community physicians emphasized personal contacts to address the lack of information and to overcome patient fears and suspicions, while the cancer program physicians emphasized printed materials. There was no difference by region in the barriers identified in the focus group workshops; however, the proposed solutions to overcoming the barriers were specific to each site. CONCLUSION: The four-step process developed by the ECOG and the NMA used the focus group methodology to identify and overcome barriers to participation of African Americans in cancer clinical trials. Outreach efforts to educate patients, their families, and community physicians about cancer clinical trials should be directed at overcoming patient suspicions and providing practical information to physicians about specific trials and how to enroll patients.