Minority Accrual Research Articles

Overcoming racial and ethnic disparities in clinical trial enrollment real world evidence from an NCI-Designated Cancer Center in a minority majority county.

e13708 Background: Significant racial and ethnic disparities continue to persist in clinical trial enrollment. Specifically, Asian and Hispanic individuals are severely underrepresented compared to their census estimates and make up as little as 1% and 6% respectively of all clinical trial enrollments [PMID: 35875251]. This limits the generalizability of clinical trials and consequently the application of novel therapeutics for diverse populations. This observational study looks at enrollment demographics at the University of California, Irvine (UCI) with an emphasis on minority participation in clinical trials. We hypothesized that minorities would be underrepresented in our enrollment population. Methods: The UCI Chao Family Comprehensive Cancer Center (CFCCC) is located in Orange County (OC), CA, a minority-majority county. Enrollment data from clinical trials was collected from 2015-2023 through the CFCCC clinical research database. Demographics were compared to data provided by the NIH SEER reports in both OC and United States. Results: Between 2015-2023, 2315 individuals across 3 UCI Health facilities were enrolled. Demographics were as follows: White, Asian, Black, American Indian/Alaska Native, mixed/unknown race (66.4%/20.1%/2.4%/0.7%/0.7%/ 9.3%). Non-Hispanic vs Hispanic ethnicity (77.8%/20.6%). Female vs Male sex (47.6%/52.3%). Age <70 vs >70 years (78.6%/21.4%). Low Income/Health Professional Shortage Areas (HPSA) vs non-Low Income/HPSA (44.9%/55.0%). Study Phase: Phase I/II (39.2%), Phase II (28.0%), Phase III (29.3%), Phase II/III (3.0%), and Phase IV (0.3%). Study sponsor: Industry (61.2%), Investigator initiated (23.5), Cooperative group (14.9%), other (0.3%). Most notably, the Asian enrollment (20.1%) and Hispanic enrollment (20.6%) exceeded demographic representation of Asians (15.6%) and Hispanics (17.3%) in OC. Conclusions: Our results demonstrate that accrual of minorities is feasible across all types of clinical trials. These findings suggest that minorities are not inherently less likely to enroll in clinical trials. A clinical trial portfolio mirroring the catchment area might improve accrual of minorities. Enrollment based on race/ethnicity and trial phase/sponsor will be presented at the meeting.

Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302).

11019 Background: Studies show that <10% of patients with cancer participate in clinical trials. Pragmatica – Lung (SWOG S2302) utilizes a pragmatic approach for a registrational (FDA) trial that allows less data collection and broader eligibility, thus decreasing barriers to diverse enrollment. S2302 aims to improve overall and diverse accrual by using a novel trial design and multilevel community engagement. Methods: S2302 is a real-world randomized phase III registrational study comparing pembrolizumab + ramucirumab vs investigator-chosen standard therapy in 2nd line advanced/metastatic NSCLC. A multi-stakeholder recruitment plan was developed to improve diverse accrual (with initial focus on recruiting Black patients). The plan was vetted through SWOG communications and SWOG Lung Committee’s Working Group, DEI champion, patient advocate, and community engagement subcommittee. The DEI champion identified sites in the Southeast with high minority accrual in prior trials and completed directed informational visits. An external firm created culturally and linguistically appropriate patient education material, engaged sites with historically high accrual of Black and/or LatinX patients, leveraged advocacy partners to improve community awareness, and monitored enrollment by site. A monthly accrual report with demographic summaries (including age, sex, race, ethnicity) and site enrollment information is generated from SWOG Statistics and Data Management Center to monitor accrual rate and diversity. Results: From March through December 2023 (Table), the study accrued 37% of its goal and is enrolling above its target rate of 25 pts/mo averaging 36/mo over the last 5 months. Of enrolled pts, 58% are male, 13% are Black, and 3% are LatinX; from 59 academic, 67 community (13% rural), and 2 VA sites. Comparatively, LungMAP S1800A (the phase II precursor to S2302) accrued 7% Black and 1.5% LatinX pts with an average accrual of 9.2 pts/mo. Through November, the external firm contacted 24 site PIs (63% community-based), whose sites had collectively enrolled 16 pts, for a normalized pre-call rate of 0.1340 pts/mo. After contact and through November, these sites enrolled 23 pts, a rate of 0.3835 pts/mo – a 186% increase. Conclusions: The intentional, multi-pronged recruitment plan has exceeded historical overall, Black, and LatinX patient accrual rates. The data highlight novel approaches to trial design, recruitment strategies, and increased internal and external collaboration resulting in improved diversity of clinical trial enrollment and may be a potential toolkit for future trials. Support: NIH/NCI grants U10CA180888 and U10CA180819; and in part by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Eli Lilly and Company. Clinical trial information: NCT05633602 . [Table: see text]

Impact of Clinical Trial Design on Recruitment of Racial and Ethnic Minorities.

Knowledge related to how oncology treatment trial design influences enrollment of racial and ethnic minorities is limited. Rigorous identification of clinical trial design parameters that associate favorably with minority accrual provides educational opportunities for individuals interested in designing more representative treatment trials. We identified oncology trials with a minimum of 10 patients at an NCI-Designated Comprehensive Cancer Center from 2010 to 2021. We defined a study endpoint of racial and ethnic minority accrual greater than zero. Multivariable logistic regression was used to determine whether co-variables predicted our study endpoint. P-values of less than 0.05 were considered significant. A total of 352 cancer trials met eligibility criteria. These studies enrolled a total of 7981 patients with a total of 926 racial and ethnic minorities leading to a median enrollment of 10%. Trials open in community sites (yes versus no) were more likely to have a minority patient (OR, 2.21; 95% CI, 1.02-4.96) as well as pilot/phase I studies compared to phase II/III (OR, 3.19; 95% CI, 1.34-8.26). Trials incorporating immunotherapy (yes versus no) were less likely to have a minority patient (OR, 0.47; 95% CI, 0.23-0.94). Trials open in community sites as well as early phase treatment studies were more likely to accrue minority patients. However, studies including immunotherapy were less likely to accrue racial and ethnic minorities. Knowledge gained from our analysis may help individuals design oncology treatment trials that are representative of more diverse populations.

Abstract 1006: Revitalizing the accrual of women and minorities: Unique drivers of therapeutic clinical trial enrollment for underrepresented patients with diffuse glioma

Abstract Introduction: Despite the enactment of the 1993 NIH Revitalization Act to improve accrual of women and minorities in clinical trials, these groups remain underrepresented. This study aims to uncover drivers of therapeutic clinical trial enrollment that are unique to women and minority patients with low- and high-grade glioma. Methods: Adult glioma patients who received care from the UCSF Brain Tumor Center between 1997-2017 were identified in a prospective registry. Dividing the cohort into subgroups by gender and NIH-designated minority status, factors associated with therapeutic clinical trial enrollment on univariate logistic regression (p<0.2) were selected for multivariate logistic regression. Results: There were 351 trial participants (41% women, 12% minority) and 627 non-trial participants (44% women, 17% minority). Among women only, seizure at presentation (OR 2.10, p=0.008) was associated with increased odds of trial enrollment. In contrast, among men only, higher median household income (OR 1.09 per $10,000 increase, p=0.006), higher WHO tumor grade (OR 1.89, p=0.045), and occupational status according to the International Standard Classification of Occupations [professionals (e.g., physicians) vs managers (e.g., supervisory positions), OR 2.87, p=0.043] were associated with increased odds of trial enrollment. Among both women and men, lack of insurance (women: OR 0.49, p=0.02; men: OR 0.55, p=0.031) and no treatment with chemotherapy (women: OR 0.18, p=0.001; men: OR 0.34, p=0.002) were associated with decreased odds of clinical trial enrollment, whereas higher KPS (women: 90 vs <80, OR 3.16, p=0.003; men: 90 vs <80, OR 3.15, p=0.002) was associated with increased odds of trial enrollment. Among NIH-designated minority patients, older age (OR 0.66 per 10-year increase, p=0.033) and non-English preferred language (OR: 0.30, p=0.035) were associated with decreased odds of trial enrollment on univariate analysis, but not on multivariate analysis. Among non-minority patients, lack of insurance (OR 0.58, p=0.008) and no chemotherapy treatment (OR 0.25, p<0.001) were associated with decreased odds of trial enrollment, whereas seizure at presentation (OR 1.80, p=0.001), higher neighborhood household income (OR 1.07 per $10,000 increase, p=0.004), higher WHO grade (4 vs 2-3, OR 1.86, p=0.015), higher KPS (90 vs <80, OR 3.21, p<0.0001), and lower extent of tumor resection (80-89% vs 100%, OR 2.16, p=0.047) were associated with increased odds of trial enrollment. Conclusion: Drivers of trial enrollment differed for women and minority patients with glioma. Non-English-speaking minority patients may face additional barriers to trial enrollment requiring targeted interventions. Our findings can revitalize and tailor efforts to recruit women and minority patients to therapeutic clinical trials in neuro-oncology. Citation Format: Mulki Mehari, Gayathri Warrier, Sheantel Reihl, Abraham Dada, Aymen Kabir, Mikias Negussie, Cesar Nava Gonzales, Ugonma Chukwueke, Alyx Porter, Shawn Hervey-Jumper. Revitalizing the accrual of women and minorities: Unique drivers of therapeutic clinical trial enrollment for underrepresented patients with diffuse glioma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1006.

Abstract A001: Tracking the Relationship between Accrual and Comorbidities in Clinical TRrial Enrollment (TRACE)

Abstract Background: Clinical trial accrual disparities are pervasive and multifactorial. Prior research shows differential racial enrollment patterns of cancer patients due to comorbidity-based exclusion criteria (CEC). Uterine cancer (UC) has one of the largest racial disparities in incidence and mortality, yet the impact of CEC on accrual of racial minorities into UC trials is unknown. Objective/Hypothesis: To 1) characterize the presenting comorbidity profile of UC patients, by race and 2) use real-world data to quantify expected effects of common CEC on UC trial accrual. We hypothesize that racial minorities with UC have more comorbidities resulting in higher exclusion from trials than Whites. Method: In this observational, cross-sectional study, we used the Vizient ® Clinical Data Base [permission of Vizient Inc. (all rights reserved)] with 8.5 million inpatient and 130 million outpatient encounter level claims annually. We identified individuals ≥18yo with a UC diagnosis, 2002–2021. Demographic variables and comorbidity diagnoses were identified by ICD9/10 codes and used to construct Charlson, Elixhauser, and National Cancer Institute (NCI) comorbidity indices (CI). Individual comorbidity-based and summary theoretical ineligibility rates were calculated, by race, based on a modified set of CEC (Riner et al, JCO 2022). Ineligibility rates were compared between groups and differences assessed with logistic regression using STATA v.18. Result: We identified 384,093 UC patients. 73% were White, 14% Black, 11% unknown race, and 3% Asian. The majority (61%) were of non-Hispanic ethnicity. On average, Blacks had more comorbidities than Whites, Asians, or those of unknown race [1.3 (SD 2), 0.7 (SD 1.6), 0.6 (SD 1.3), 0.9 (SD 1.6), respectively]. For NCI CI, Blacks had the highest CI score (0.8, SD 1.4) while Asians the lowest (0.4, SD 0.9). Whites and those of unknown race had similar scores (0.5, SD 1.1) (all p-values < 0.001). Individual comorbidity prevalence varied significantly by race. Blacks (12%) with UC were more likely to have renal failure compared to Whites (5%). Asians (14%) and Whites (15%) had similar rates of diabetes while Blacks had the highest (24%). Hypertension was higher in Blacks (50%), followed by Whites (33%) then Asians (28%). In simulation analyses, odds of trial exclusion based on comorbidity status were two times higher in Blacks compared to Whites (OR 2.09, 95% CI 2.05-2.13). Those of unknown race had slightly higher odds (OR 1.04, 95% CI 1.02-1.07) and Asians lower odds (OR 0.89, 95% CI 0.86-0.93) of being ineligible relative to Whites. Conclusion: For UC patients, comorbidity prevalence and CI scores varied by race. This results in significant differences in trial eligibility at baseline before any patient engagement. Quantifying the distribution of comorbidities is critical because it allows us to anticipate, statistically, how the accrual of minorities may be hampered by individual CEC. This in turn can support equity efforts of targeted oversampling and strategic site selection to ensure diverse participants. Citation Format: Ann Oluloro, Mindy Pike, Adrienne Moore, Tiffany Luu, Soledad Jorge, Kemi M. Doll. Tracking the Relationship between Accrual and Comorbidities in Clinical TRrial Enrollment (TRACE) [abstract]. In: Proceedings of the AACR Special Conference on Endometrial Cancer: Transforming Care through Science; 2023 Nov 16-18; Boston, Massachusetts. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(5_Suppl):Abstract nr A001.

A Mixed-Method Approach to Explore Successful Recruitment and Treatment of Minority Patients on Therapeutic Cancer Clinical Trials at a Tertiary Referral Center Using Photo-Elicitation Interviews.

Under-represented minority patients (URM) enroll in cancer clinical trials (CCT) at low rates. To gain insight into barriers and facilitators to CCT enrollment, we conducted a mixed method study of URM patients who were successfully treated on a therapeutic CCT from 2018-2021 at all institutional sites. A retrospective chart review of 270 minority patients was conducted to identify patient demographics and characteristics. All living URM patients were requested to participate in a survey and qualitative interview using a photo elicitation technique. Most patients who participated in a CCT were patients with solid tumors, metastatic disease, and did not live in a rural area. Survey data showed that the two most significant drivers of CCT enrollment were potential of benefit to self and to others (altruism). Direct recommendation from a healthcare provider to participate in CCT was critical. URM patients enrolled on a CCT experience a significant burden of symptoms and financial distress. Key themes identified from the interviews that motivated patients to participate included chance for cure, staying positive, altruism and advancement of science, and having diverse representation in research. Patient-level facilitators to participation included social support, cost coverage, and limited treatment options. Sytematic facilitators identified included minimizing logistical barriers, decentralizing cancer clinical trials, increasing awareness via patient narratives, diversifying research staff, minimizing cost, and being clear on puropose and benefit of the trial. Success stories of minority recruitment can provide useful information to enhance minority accrual. Photo elicitation interviews provide rich narratives of patient experience.

Absolute neutrophil count (ANC) cutoff in cancer clinical trials: Implications for minority accrual in the United States (US).

101 Background: In the US, minority patients are underrepresented in cancer clinical trials. This is due to multiple factors, including socioeconomic barriers, limited medical insurance coverage and restrictive clinical trial eligibility, e.g., ANC cutoff. For the latter, conservative ANC cutoff disadvantages Black patients. Two-in-three Black individuals have a Duffy-null phenotype, that is associated with lower ANC with 5% prevalence of ANC <1,500 cells/µl. To improve Black patient accrual to cancer clinical trials, lowering the ANC cutoff was proposed as a potential solution over a decade ago. Its implementation is not known. This study evaluates the ANC cutoff values as part of the eligibility criteria for cancer clinical trials. Methods: We accessed the Clinicaltrials.gov website on 5/25/2023 and obtained the ANC cutoff of cancer clinical trials conducted in the US. We included adult therapeutic trials in the phases of recruiting, not yet recruiting, enrolling by invitation, and active-not yet recruiting. Trials with drug interventions were selected. Those focusing on surgical, behavioral, nutritional and radiotherapeutic interventions were excluded. All ANC cutoff values were converted to “cells/µl” for analysis. Results: A total of 911 trials were evaluated, and 470 met the eligibility criteria. Of the 470 trials, 366 (78%) involved solid malignancies, and 104 (22%) involved hematologic malignancies. Hematologic trials have significantly lower ANC cutoffs compared to solid tumor trials with median ANC cutoff of 1,000 (range, 250-2000) vs. 1,500 (range 250-3,000); p=<0.001. In all, 323 trials (68.7%) required patients to have ANC >1,500, and 116 trials (24.6%), primarily hematologic, required patients to have ANC >1,000. For myeloma and prostate cancer, two cancers with higher incidence among Blacks, 12.9% and 86.4% of the trials require ANC >1,500, respectively. All genitourinary, breast, head & neck, sarcoma, lung, skin, and neuroendocrine tumor trials excluded patients with ANC <1,000. Conclusions: Most hematologic malignancy trials have a more liberal ANC cutoff allowing patients with ANC <1,500 to participate. However, solid tumor trials remain more conservative, with 4 in 5 trials requiring an ANC cutoff of >1,500. A strict ANC cutoff remains a barrier to minority accrual.[Table: see text]

Cancer survivors mentoring peers to address disparities in clinical trials: A quality improvement project within the 4th Angel Mentoring Program.

99 Background: As part of a National Cancer Institute designated Cancer Center, our goal for minority accrual to clinical trials (CTs) is 15%, in 2022 was 13.2%, and we currently enroll at 14.1%. To maintain and grow this volume, we created an initiative to draw on our already established survivor-to-patient/caregiver mentoring program called the 4th Angel Mentoring Program (4AMP). Mentors could share their personal experiences in CTs one-on-one to mentees, which could spark interest, education, decision making, and address disparities in CTs enrollment, especially among medically underserved communities. Methods: 4AMP is an innovative, interactive approach to cancer support in which patients and caregivers are matched with trained volunteer peer mentors. Prior to 2022, the program did not directly address CTs. In April 2022, we conducted a survey of mentors to gauge interest in sharing CTs experiences, and the extent to which the current mentor pool had participated in CTs, when, and for which disease areas. Based on mentor support, we began matching along CT interest in June 2022. We publicized the program to mentors, internally on a cancer center-wide message board, in an email blast to the cancer center social work team, as well as emails and word-of-mouth to clinicians and social workers with high referral rates to the program. Results: We emailed the survey to 836 persons, 300 replied for a response rate of 36%. 87 (29%) of mentors that responded to the survey had prior participation in CTs, with 58 (66%) of those experienced mentors agreeing to speak to mentees about CTs. 6 (10%) identified as Black/African-American, 44 (75%) as White, and 8 (14%) did not share their racial identity. One patient identified as Latino/fluent Spanish speaker. The average mentor age was 57 years old. 32 (55%) identified as female and 26 (45%) as male. In response to an open-ended question, participants voiced support for the Program, reiterated interest in mentoring and supported matching along CTs experience. Mentors expressed great interest to speak with patients about their positive CTs experiences because CTs helped them on their cancer journey and they felt that sharing patient testimonials could address racial disparities in CTs. From June 2022 to February 2023, three mentees (2 male, 1 female, none identified racial/ethnic identity) matched with mentors to discuss interest in CTs. Most patient matches made by the program (673 during this period) were not due CT interest; patients can request a mentor at any time in their cancer journey and most do so near the beginning of diagnosis/treatment. Conclusions: 4AMP will continue offering matching along CTs interest and recording mentors with CTs experience. Future projects will address how to better utilize mentor testimonials about CTs, likely outside of mentoring, and how to expand interest in CTs among mentees and newly diagnosed patients.

Increasing Accrual of Racial and Ethnic Minorities in Breast Cancer Clinical Trials by Partnering with Community Hospitals

Clinical trials provide the highest level of evidence in evaluating the safety and efficacy of new radiation approaches for breast cancer. However, there is a significant lack of racial and ethnic diversity among participants who are enrolled. This discrepancy in research inclusion leads to limitations in applying clinical data, therapeutic indices, technique safety, and toxicity to a diverse patient population. A community-based approach, such as the inclusion of community hospitals in trial enrollment, has been shown to boost participation within these underserved populations. The aim of this study was to evaluate the rate of enrollment of racial and ethnic minorities in breast cancer clinical trials with the inclusion of community hospitals within an NYC hospital system. Trial enrollment of breast cancer patients at 3 hospitals was retrospectively assessed. Patient demographics, including age, race, and ethnicity, were compared by enrollment setting. Eligible trials included prospective, randomized clinical trials assessing breast cancer irradiation. Participating hospitals included an academic hospital in Manhattan (MH), and 2 community hospitals in Brooklyn (BH) and Queens (QH). Collectively, these hospitals have a catchment area of 6.2 million, of which 35.2% are White, 19.7% are Asian, 18.3% are Black/African American (B/AA), and 21.2% are Hispanic/Latino (H/L). There is a wide demographic variety within this catchment area. BH serves neighborhoods with a B/AA population as high as 85% and QH serves neighborhoods with an Asian population as high as 54%. From January to December 2022, 146 patients were enrolled in 4 breast cancer trials opened at MH (59.6%, n = 87), BH (28.8%, n = 42), and QH (11.6%, n = 17). The average age was 63.3 (SD = 12.1). Of all patients enrolled, 52.7% identified as White, 23.2% as B/AA, 13% as Asian, and 8.9% as H/L. Of the patients enrolled at MH, 64.4% identified as White, 12.6% as B/AA, 8% as Asian, and 8% as H/L. At BH, 50% identified as B/AA, 38% as White, 4.7% as Asian, and 11.9% as H/L. At QH, 58.8% identified as Asian, 29.4% as White, and 11.8% as B/AA. B/AA (OR = 4.41, 95% CI, 1.94-10.03; p<.01) and Asian (OR = 2.92, 95% CI, 1.07-7.93; p<.05) patients were more likely to be enrolled at a community hospital when compared to an academic hospital. There was no difference in enrollment rates between campuses for H/L patients (OR = 1.29, 95% CI, 0.41-4.06; p = .66). Enrollment of participants from underrepresented racial and ethnic populations in clinical trials is critical to ensuring health equity. These findings suggest partnerships with community hospitals located in underserved populations can be a strategy to improve diversity among clinical trial participants. As it is well-documented that community hospitals can deliver high quality research with similar trial metrics to larger, academic hospitals, partnerships with community hospitals are a feasible way to reduce disparities in breast cancer research.

Strategies to increase accrual of underrepresented populations in Alliance NCTN trials.

6509 Background: Accrual of underrepresented populations (URPs-racial and ethnic minorities, women, rural populations, and younger and older populations) to clinical trials has been historically low, hampering progress in cancer treatment, symptom intervention and prevention for all. In 2018, the Alliance for Clinical Trials in Oncology (Alliance), as a part of the NCI's National Clinical Trials Network (NCTN) and a Research Base for the NCI Community Oncology Research Program (NCORP) began a multi-pronged strategy to increase accrual of underrepresented minorities by race and ethnicity (URMs) to both treatment and cancer control trials conducted by the Alliance. Methods: Alliance leadership set a goal of 20% accrual for racial and ethnic minorities to all trials in 2018. The Health Disparities Committee (HDC) implemented several strategies over time including leadership promotion/expectation of goals; funding junior investigators and special projects focusing on URPs; working groups for specific populations in HDC; HDC co-chairs to selected protocols; translation services of patient facing materials; opening studies at NCORP Minority Underserved Sites; real time monitoring of accrual demographics, by Alliance and by site; protocols addressing aims for specific populations; closing protocol enrollment to majority populations; and increasing the study sample size to enroll additional minority participants to allow for analyzing intervention effects by subgroups. Results: Accrual data from 117 NCTN and NCORP trials led by Alliance was included from 2014-2022. Over time, accrual of racial and ethnic minorities increased from 13.6% to 25.3% for treatment and 13% to 21.5% for cancer control trials. This results in overall increase from 13.5 % to 23.6% of URMs for all trials, a 74.8% improvement. Conclusions: Intentional approaches to increase URMs has led to an increase in URM accruals to Alliance trials. Future strategies include implementation of the Alliance Patient Questionnaire to prospectively measure the prevalence of specific social determinants of health among patients enrolled to further expand the understanding and address the needs of unique population accrued to Alliance trials. In addition, accrual of women, rural populations, and younger and older adults (65+ years) are now being monitored over time to increase all URP accruals.

Patterns of diversity in cancer clinical trial enrollment at a New York City academic health system, 2018-2022.

e18630 Background: Mitigation of cancer clinical trial (CT) enrollment disparities is increasingly prioritized in healthcare, but disparity metrics are inconsistently published by individual health systems. We aimed to assess health-system-level trends in CT enrollment by race, ethnicity, sex, and treatment location (network vs main hospital) during the COVID-19 pandemic, as well as to evaluate county-level disparities in CT accrual fraction (AF) over a five-year period. Methods: This was a cross-sectional study of the population enrolled on therapeutic cancer CTs in a New York City academic health system (AHS) from 2018-2022. Demographics were descriptively analyzed and compared with most recent public NCI-reported therapeutic trial accrual data. New York County 5-year cancer incidence was estimated for each demographic subgroup using age-adjusted cancer incidence rates from public SEER/NPCR data and US Census data. Primary endpoint was AF, defined as proportion of patients accrued relative to cancer incidence. Results: Of 2,533 patients enrolled on CTs over the 5-year period, 51% were White, 18% Black, 17% Hispanic, 9.8% Asian, 0.08% American Indian/AK Native, 0% Pacific Islander, and 3.9% Multiple/unknown race; 47% were female. Minority accrual proportion was higher than that of NCI accrual data (45% vs 25%, p =&lt; 0.001). Annual enrollment fell from maximum 571 patients in 2019 to 457 in 2020, then increased to 499 by 2022. Meanwhile, the proportion of minority enrollment increased to a peak of 49.2% in 2020 and fell to 45% in 2022. Female enrollment of 49% in 2018 decreased to 42% in 2021, increasing sharply to 51% in 2022. On multivariate analysis, Black and Asian patients were more likely to be enrolled after the start of the pandemic than White patients (ORs 1.3, 95% CI 1.1-1.6; 1.4, 1.03-1.8). Black, Asian, and female patients were more likely to be enrolled at network hospital locations than White or male patients, respectively (ORs 1.9, 95% CI 1.3-2.7; 2, 1.2-3.1; 14, 8.6-21). Relative to county-level estimated cancer incidence, Black patients had a higher AF than White patients (0.96% vs 0.77%, OR 1.3, 95% CI 1.1-1.4), while Hispanic patients had a lower AF (0.55%, OR 0.72, 95% CI 0.64-0.8). Women had a lower AF than men (0.66% vs 0.74%, OR 0.9, 95% CI 0.83-0.97). Conclusions: Minority accrual at this AHS was higher than nationally reported. Despite decreased total accrual numbers in 2020 due to the COVID-19 pandemic, high accrual diversity was maintained. County-level AF disparities among women and Hispanic patients suggest opportunities for improvement in community outreach, and greater diversity of clinical trial enrollees at network hospitals may reflect successful outreach to the communities they serve.

Abstract P6-09-03: Examining recollections of Black women with breast cancer who participated in clinical trials: A grounded practical theory study of patient-provider communication

Abstract Introduction: The presence of strong barriers to research participation for Black and Brown women is indisputable. However, existing evidence clearly supports the possibility of equal levels of participation among members of minoritized populations in past breast cancer clinical trials, demonstrating that while these participation barriers do undoubtedly exist, they are not always insurmountable. A main implication of this current study is that researchers should take greater strides to remove the onus of recruitment responsibility from racialized population members, and instead leave it with the providers, investigators, and health care teams who hold enough power to make change. Purpose: This project takes a grounded practical theory (GPT) approach to engage with Black women who have been diagnosed with breast cancer and have participated in a breast cancer clinical trial and explores their recollections of conversations with their providers. GPT focuses on reconstructing particular communication practices, highlighting both the important procedural role of communication in practice and its ability to present intricate complications that echo society’s norms and values. The aim of this work is to investigate and analyze those patient-provider conversations to try to illuminate how providers can better engage these women in ways that will positively influence their perceptions of breast cancer clinical trial participation. Methods: The current study was part of a larger project examining the recruitment of Black women to breast cancer clinical trials. Fourteen women (N=14) from six different states in the U.S., all of whom self-identified as Black, Black American, or African American, agreed to be interviewed as part of a larger study. All participants had participated or were currently participating in a breast cancer clinical trial. The interviews yielded a wealth of interesting and potentially important additional data about Black female breast cancer patients and their communication experiences with their providers. Employing grounded practical theory as a framework helped increase insight into the patient-provider communication needs of Black women who have participated in a breast cancer clinical trial. Results: Findings were summarized into four categories: 1) the participants held differing perspectives and personal impressions toward their providers; 2) the women reflect on their individual breast cancer journeys through richly described incidences, describing searching for, and finding trials on their own, or being guided by healthcare providers who suggested a clinical trial for them; 3) each participant’s shared details of their unique communication relationship with medical and research providers; and 4) the cultural aspects of participants’ patient-provider communication, focusing primarily on their expressions of faith. These findings have important implications for health communication scholars, healthcare providers, and breast cancer clinical trial research principal investigators and team members. Conclusion: As opposed to the conclusion that one may draw from most published explanations of poor minority accrual to clinical trials, which appear to put the blame on the minoritized population members themselves, the current work outlines the actions and non-actions of many providers, and suggests that adjusting to approaches that demonstrate more encouragement and acceptance of their patients might result in better clinical trial participation outcomes from these group members. Citation Format: Precious Okoruwa, Katherine E. Ridley-Merriweather. Examining recollections of Black women with breast cancer who participated in clinical trials: A grounded practical theory study of patient-provider communication [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-09-03.

A Comprehensive Analysis of Institutional and Nationwide Datasets Identifies Key Parameters that Influence Racial Minority Enrollment onto Clinical Trials

<h3>Purpose/Objective(s)</h3> Minority accrual to clinical cancer treatment trials remains consistently low across the United States. We hypothesize that specific aspects of clinical cancer trials associate favorably with minority accrual, and may guide future clinical trial design. <h3>Materials/Methods</h3> We identified cancer treatment trials with a minimum of 10 patients at a multi-institutional NCI designated cancer center from 2010-2022. We also analyzed the National Cancer Database (NCDB) from 2004 to 2018 to assess co-variables that influence minority accrual across the United States. Racial minorities were defined as any non-white individual for both our institutional and NCDB cohorts. Our study endpoint was the probability of enrolling a minority patient on a clinical cancer treatment trial. Separate univariable and multivariable logistic regression were used to determine whether co-variables from either our institutional dataset or the NCDB associated with the study endpoint. P-values of less than 0.05 were considered statistically significant. All analysis was performed in R (R Foundation for Statistical Computing, version 4.0.2). <h3>Results</h3> We identified a total of 352 cancer treatment trials from our multi-institutional cohort. These trials enrolled a total of 7,981 patients, and a total of 969 minorities (12%). Clinical trials treating breast and genitourinary malignancies had a favorable association with accruing a minority patient when compared to other solid tumors (OR 1.32 95% CI 1.04-1.66 and OR 1.33, 95% CI 1.02-1.71). Phase II clinical trials had a less favorable association with accruing a minority patient (OR 0.75, 95% CI 0.62 – 0.91) when compared to early phase trials (pilot + phase I + phase I/II). Analysis of the NCDB identified 19,139 minorities enrolled on institutional or double-blinded clinical trials. Minorities enrolled on clinical trials were more likely to be female versus male (OR 1.22, 95% CI 1.09-1.37), un-insured versus private insurance or Medicare (OR 2.22, 95% CI 1.67 – 2.94 and OR 1.96, 95% CI 1.43 – 2.63), live within 30 miles of their hospital (OR 2.33, 95% CI 2.08 – 2.63), receive treatment at academic versus community facilities (OR 1.75, 95% CI 1.52-2.04), and be treated with surgery (OR 1.59, 95% CI 1.41 – 1.79). Minority patients enrolled on clinical trials were more likely to have breast and genitourinary cancers (OR 1.54, 95% CI 1.31 – 1.81 and OR 1.35, 95% CI 1.14 – 1.61). <h3>Conclusion</h3> Twelve percent of patients that enrolled on clinical trials in our institutional cohort were minorities, which is comparable to current minority representation in NCI trials. Our analysis found that minority patients enrolled on early phase clinical trials, breast and genitourinary treatment trials, tended to be female, un-insured, live within 30 miles of a facility, and receive surgical treatment. This analysis demonstrates that minority patients favorably associate with specific aspects of cancer treatment trials that should be addressed in future clinical trial design.

Interventions to increase racial and ethnic minority accrual into cancer clinical trials: A systematic review.

Racial and ethnic minorities (REMs) continue to be underrepresented in clinical trials despite the 1993 National Institutes of Health's Revitalization Act mandating the representation of women and underrepresented minority groups in clinical trials. Although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates are disproportionately low at 4% to 6% and 3% to 6%, respectively. A systematic review exploring interventions aimed at improving cancer clinical trial (CCT) enrollment for REMs was conducted. A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies since 1993. Inclusion criteria included peer-reviewed, US-based studies with interventions aimed to recruit underrepresented minority adult patients into cancer clinical trials. REM groups were defined as Black, Hispanic, Asian, American Indian, and Native Hawaiian/other Pacific Islander. The systematic search identified 3123 studies, of which nine met inclusion criteria. Interventions included patient navigation/coaching (n= 4), a clinical trial educational video (n= 2), institutional research infrastructure changes (n= 1), a relationship building and social marketing recruitment model (n= 1), and cultural competency training for providers (n= 1). A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos and an institutional research infrastructure change. This systematic review illustrates several potential mechanisms by which to increase CCT recruitment for patients of REM backgrounds in various clinical settings. More randomized controlled trials are needed to further explore the benefits of these interventions for REMs.

Identifying and overcoming barriers to participation of minority populations in clinical trials: Lessons learned from the VanDAAM study.

Participation in cancer research trials by minority populations is imperative in reducing disparities in clinical outcomes. Even with increased awareness of the importance of minority patient inclusion in clinical research to improve cancer care and survival, significant barriers persist in accruing and retaining minority patients into clinical trials. This study sought to identify and address barriers to minority accrual to a minimal risk clinical research study in real-time.

Overcoming racial disparities in cancer clinical trial enrollment of Asians and Native Hawaiians

BackgroundAsians and Native Hawaiians are two of the fastest growing minority populations in the United States, however these racial minority groups are severely underrepresented in clinical trials. This study looks at cancer clinical trial accrual among Asians and Native Hawaiians in a community-based network with a mission of increasing minority accrual to studies. MethodsThe University of Hawaii Cancer Center (UHCC) network enrolls patients to treatment and non-treatment cancer studies. Enrollment on studies opened between 2009 and 2013 were obtained from UHCC's clinical trial management system. Incidence of cancer by race was acquired from the Hawaii Tumor Registry. Enrollment fractions were compared for the most common races in the state: White, Asian (specifically Chinese, Filipino, Japanese), and Native Hawaiian. ResultsWhites comprised the largest proportion of cancer patients and participants in trials. Asians and Native Hawaiians were enrolled into cancer clinical trials at the same or higher enrollment fraction compared to Whites. Chinese, Japanese, and Native Hawaiian patients participated in treatment trials significantly more often than Whites (p < 0.05). Similarly, Chinese and Native Hawaiians enrolled in non-treatment trials at a significantly higher rate compared to Whites (p < 0.05). ConclusionsThe UHCC network has instituted many strategies to increase minority accrual that have likely led to Asian and Native Hawaiian patients participating in studies at least as often as White patients. The strategies implemented at UHCC may benefit similar communities with a high number of minority cancer patients.

Abstract PR-05: Worsening disparities of racial minority participation in phase 1 early drug development trials in the United States, 2001-2018

Abstract Purpose: The National Institute of Health has advocated for broad representation of racial and ethnic groups in drug development trials after the introduction of the Revitalization Act in 1993. However, no studies to date have specifically examined demographic disparities among participants in Phase 1 drug development trials. Herein we sought to assess the distribution of and changes in enrollment of racial and ethnic minorities in United States Phase 1 early drug trials for metastatic cancer treatment from 2001 to 2018. Patients and Methods: We queried the ClinicalTrials.gov website to identify completed Phase 1 drug trials in the U.S. from 2001 to 2018 with published results and participants &amp;gt; 18 years of age with metastatic cancer. We reviewed publications from each study to identify racial and ethnic compositions of participants. We compared the proportions of each racial/ethnic group of trial participants to those of corresponding annual incidence data from Surveillance, Epidemiology, and End Results (SEER); for each racial/ethnic group, the difference between trial and SEER proportions was examined using a two-sample test for equality of proportions with continuity correction. Results: We identified a cohort of 236 trials; 72% were industry-sponsored, 19% focused on metastatic breast cancer, 14.8% focused on metastatic colorectal cancer, and 28.3% were basket trials targeting specific genetic pathways with mixed histologies. Of the 9,273 total participants, 81.5% were White, 5.7% Black, 9.4% Asian/Pacific Islander (API), 0.26% American Indian/Alaska Native, and 4.4% Hispanic/Latinx. Comparing the racial/ethnic distributions of trial participants to the corresponding SEER data revealed an excess of White and API representation (1.2% (p&amp;lt;0.005) and 2.3% (p&amp;lt;0.001), respectively), and a 6.2% deficit of Black participants (p&amp;lt;0.001). White patients were overrepresented in clinical trials beginning in 2001-2011 (+4.5% p&amp;lt;0.001)), but not in trials beginning in 2012-2018 (-0.05% p&amp;gt;0.05)). Underrepresentation in trial enrollment worsened in this time period for Black patients (-4.2% to -7.4%, respectively) and Hispanic/Latinx patients (-0.07% to -3.5%). API patients shifted from underrepresentation in 2001-2011 (-2.5%) to overrepresentation in 2012-2018 (+5.52%). Disparities in Black patient enrollment in trials conducted at academic institutions worsened from -4.36% in 2001-2011 to -7.64% in 2012-2018 (p&amp;lt;0.0001). Conclusions: There are persistent and worsening disparities in accrual of racial and ethnic minorities in phase 1 drug trials. These include decreases in enrollment of Black and Hispanic/Latinx patients in clinical trials overall, and in enrollment of Black and AI/AN patients in trials conducted at academic institutions. These findings may represent widening inequalities in access to trial sites, as well as potential systemic biases. Current efforts to diversify clinical trials should expand their reach from phases 2 and 3 to include phase 1, in order to improve equity in access to new treatments at every stage. Citation Format: Hayley M. Dunlop, Evelyn Fitzpatrick, Kevin Kurti, Stephanie Deeb, Erin Gillespie, Fumiko L. Chino, Laura Dover, Cherry Estilo, C. Jillian Tsai. Worsening disparities of racial minority participation in phase 1 early drug development trials in the United States, 2001-2018 [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 PR-05.

From community to validated measure: Development and validation of the patient-informed cancer communication scale (PICCS).

159 Background: Assessing patient-centered communication (PCC) is critical to improving quality patient-centered cancer care. While shown to be reliable and valid, most PCC measures were created by researchers, likely neglecting concerns of patients, families, and community members. PCC measures should be driven, in part, by the patient population of interest, especially given disparities in clinical communication. Our objective was to develop and validate a patient-informed PCC scale to assess cancer treatment discussions. Methods: As part of a larger study on communication and minority accrual to trials, we convened a panel of black and white cancer survivors, caregivers, and advocates. Panel members (n = 11) included 5 black and 3 white men and 1 black and 2 white women. Among them were 6 survivors and 5 caregivers. Panel members met regularly over six months to observe and discuss video-recorded treatment discussions between black and white men with prostate cancer and their physicians. Through an iterative process of generating and refining a list of physician communication behaviors they considered to be critical to PCC in a diverse patient population, they produced a list of 22 items, titled Patient-Informed Cancer Communication Scale (PICCS). We then applied the list as an observational scale to a set of video-recorded treatment discussions (n = 61) from the larger study. Trained raters applied the list and had acceptable inter-rater reliability. We used findings to determine constructs using scale development and factor analysis, then validated the scale through correlation with established scales. Results: We evaluated each item for content validity and feasibility. We divided some items that were assessing multiple attributes. The result was a 28-item scale. Using Classical Test Theory, we reduced the scale to 22 items. Using factor analysis, we identified five factors, including: 1. Treatment options (10 items a =.92); 2. Clinical relationship (6-items a =.92); 3. Prognosis and goals of treatment (2-items a =.79); 4. Explanations (2-items a =.43); and 5. Context (1-item). To validate, we correlated factors with two validated scales, one measuring physician PCC and the other patient active participation. Factor 1 was positively correlated with patient active participation ( r=.46; p=.003); Factor 2 with PCC ( r=.54, p. &lt;.001); Factor 3 with patient active participation ( r=.48; p=.002); and Factor 5 with PCC ( r=.47, p=.002). The full PICCS scale was positively correlated with patient active participation ( r=.37, p=.02). PICCS Factor 4 was not correlated to the scales. Conclusions: This community-engaged research produced a reliable and valid patient-informed scale to assess PCC during cancer clinical interactions. Next steps include translating the findings by using PICCS to train physicians to communicate effectively in a diverse patient population.

Disparities and Access to Care: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner.

Amy Pierre, MSN, ANP-BC, of Flatiron Health and Memorial Sloan Kettering Cancer Center, considers takeaways from a program targeting minority accrual to oncology trials and a study evaluating minority representation in precision oncology trials.

Abstract IA18: North Carolina Central University and Duke Cancer Institute's collaborative cancer research and education program: Connecting cancer disparities translational research, clinical trials operations, and community engagement

Abstract Three interrelated contributors to cancer disparities include the lack of diversity among investigators contributing to cancer research, the deficiency of minority participation in clinical trials and bio-banking, and the need to advance community engagement as a vital component of the translational research spectrum. The North Carolina Central University and Duke Cancer Institute's Cancer Disparities Translational Research Partnership (NCCU-DCI CDTRP) (P20 PACHE), through its Cancer Research and Education Program (C-REP), provides a Translational Immersion Experience (TIE) that spans the full translational research spectrum, for traditionally under-represented PhD students, postdoctoral fellows, and early-stage investigators. The goals of TIE are to (1) provide cancer disparities research training with an emphasis on translational laboratory science including high-throughput screening/drug discovery, (2) equip trainees with unique training and education in the operational infrastructure that supports clinical research and trials, (3) highlight strategies to increase diverse participation in clinical trials and bio banking, and (4) learn and apply principles of community engagement through community-based programs and outreach. Using multimodal training techniques, the TIE program provides training and education in real-life settings that expose trainees to the full translational research spectrum across two diseases that disproportionality affect African Americans at significantly higher rates, prostate cancer and inflammatory breast cancer. The overarching goal is to bolster our trainees' experiences and training to contribute to innovative technologies and discoveries and provide access to training that spans beyond the traditional curriculum in areas of high need in translational cancer disparities research such as minority accrual and clinical trials operations. The program includes evidence-based workshops in healthy mentor-mentee relationships, building and sustaining resilience, and sharpening grantwriting skills coupled with ongoing external evaluation to provide real-time feedback on the program. We present the preliminary evaluation data based on the first cohort of the C-REP TIE program. Citation Format: Kevin P. Williams, Nadine J. Barrett, Carla E. Oldham, Holly Hough, Artis Woodard, Jennifer Freedman, Gayathri R. Devi, Steven R. Patierno. North Carolina Central University and Duke Cancer Institute's collaborative cancer research and education program: Connecting cancer disparities translational research, clinical trials operations, and community engagement [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 IA18.