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Background: Patients with higher socioeconomic status (SES) are overrepresented in NCI-sponsored cancer clinical trials (CCT). Inadequate access, social and cultural barriers have been described as reasons for poor accrual of patients with low SES into clinical trials. Racial minorities including African Americans (AA) and Hispanics are underrepresented in CCT and often experience issues related to lack of access. On the other hand, survey studies throughout United States suggest equal willingness for participation in CCT among all racial categories. When access to CCT is not a barrier to enrollment, the rate of CCT participation by Racial and Ethnic minorities with low SES is not well studied. Methods: We performed a retrospective review of the database of new patients screened for breast CCT at Dan L Duncan Comprehensive Cancer Center (DLDCCC). DLDCCC is an ideal venue for studies on clinical trial diversity because it provides cancer care to two very different patient demographics: 1) Smith Clinic is a Harris Health System (HHS) cancer clinic where a majority of the patients are of low SES; half of our patients earn less than $25,000 annually, 60% are uninsured using a county financial assistance program called “Gold Card”, 65% are unable to speak proficient English, and 52% are Hispanic, 25% AA, 9% Caucasian and 5% Asian, 2) Baylor St Luke’s Medical Center (BSLMC) serves predominantly Caucasian patients with >95% of the patients having federal or commercial insurance. Cancer clinical trials are available at both sites, and all patients across the two clinics have equal opportunity for enrollment. The database dates back to 5/2015 and includes 3,084 patients. Using the chi-squared test, we compared the rate of trial availability, trial eligibility and enrollment for breast CCT between two patient populations receiving care at Smith clinic vs. BSLMC. We tabulated the rate of trial participation decline at each clinic per year from 5/2015 to 6/2021. The study had IRB approval from Baylor College of Medicine.Results: Among the 3,084 new-to-practice patients, 1,664 patients were seen at BSLMC and 1,420 were seen at Smith Clinic. Clinical trials were available for 758 (53.4%) patients at Smith clinic and 742 (44.6%) patients at BSLMC, p Citation Format: Maryam Nemati Shafaee, Emily L Podany, Katherine Sanchez, Nicole Higashiyama, Valentina Hoyos, Liz Binu Micheal, Kristen Otte, Anne Pavlick, Julie Nangia, Alphi Kuriakose, Kent C Osborne, Maria Jibaja-Weiss, Matthew J Ellis, Shaun Bulsara, Mothaffar Rimawi. Breast cancer clinical trial participation rate among patients of low socioeconomic status at a comprehensive cancer center [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-14-02.

100 Background: In an ideal world, the populations studied in cancer clinical trials (CCT) would be representative of the patients seen in clinic. Unfortunately, significant disparities exist in trial enrollment. Patients who are white, male, insured, or of high socioeconomic status (SES) are overrepresented in NCI-sponsored CCT. Despite data indicating equal willingness for participation in CCT across all racial groups, lack of access, cultural barriers, and social determinants of health contribute to poor accrual rates among racial and ethnic minority patients. The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) provides equal access to breast CCT at Smith Clinic (SC) within the safety-net Harris Health system and Baylor St. Luke’s Medical Center (BSLMC). The patient populations differ greatly at these two sites, with BSLMC serving > 95% insured, largely Caucasian patients, and SC serving 60% uninsured, mostly low SES patients, with > 80% racial and ethnic minorities. Despite equal access, patients at SC have a significantly higher CCT refusal rate. Methods: We performed a retrospective review of a prospectively maintained database of new patients seen at DLDCCC dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCT. 366 patients were found to be eligible for CCT. Some patients were eligible for multiple CCT, so there were 431 total offers of CCT. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the observed differences in CCT enrollment rates. Results: In the BSLMC cohort, 61% (116/204) of eligible patients enrolled in a CCT, while in the SC cohort only 39% (74/227) of eligible patients elected to enroll in CCT. This difference was significant on univariate but not multivariate analysis. There were significant differences when comparing race and trial type in the overall patient set. On univariate analysis, SC patients, African American (AA) patients, Hispanic/Latino patients, and Spanish speaking patients were significantly more likely to decline CCT participation. However, on multivariate analysis, only the AA patient category was associated with enrollment refusal (odds ratio 0.261, 95% CI 0.116-0.563, p < 0.001). On both univariate and multivariate analyses, patients were significantly more likely to accept biobanking trials (multivariate: odds ratio 12.799, 95% CI 3.777-61.403, p < 0.001). Conclusions: Based on these findings, it is likely an oversimplification to assume that equal access will lead to a complete elimination of CCT disparities. Our AA patients were significantly less likely to agree to participate in clinical trials, challenging the commonly held view that lack of access is a major barrier. We are exploring interventions designed to improve our AA patient population’s views of trial enrollment.

371 Background: The number of female veterans is increasing by more than 18,000 per year, and 700 veterans enrolled in VA healthcare are diagnosed with breast cancer each year. The American Cancer Society recommends screening MRI in women with 20-25% or greater lifetime risk of breast cancer, and primary care physicians and oncologists order breast MRIs regularly. The Michael E. DeBakey Veteran’s Affairs Medical Center (MEDVAMC) performs mammograms and ultrasounds on site, but breast MRI is not currently available. Care in the Community arranges for veterans to obtain these studies at outside facilities. This is a complex process, requiring coordination among multiple departments at the MEDVAMC, outside MRI facilities, and patients. Methods: We created a comprehensive process map for the current breast MRI ordering process to determine areas for improvement. We reviewed all breast MRI orders from 1/2019 to 5/2021 at the MEDVAMC and determined the cancellation rate and the rate of benign (BIRADS 1-2) vs non benign (BIRADS 0, 3-5) screening outcomes. We created a Pareto analysis of cancellation reasons. Our process measures were percentage of placed breast MRI orders that were cancelled and delay from MRI order to MRI performed. Our outcome measures were percentage of order cancellations due to incorrect or incomplete orders and delay from MRI order placement to results uploaded. Results: Of the 434 orders that were placed for breast MRIs, 64% were cancelled. Only 117 of the 167 patients that had MRIs ordered ultimately received one. Of the 104 patients without known malignancy who competed an MRI, 45% had non-benign findings requiring follow-up. Our pareto analysis showed that the top cancellation reason was incorrect orders, usually contrast or side verbiage. In June 2021, the CITC order set for MRI was changed from a free text box to discrete, clickable options for side and contrast. In December 2021, we held educational interventions on how to avoid delay or cancellation. Our p-chart of percentage of cancellations due to incorrect ordering shows an extremely promising decrease, with the last seven consecutive subgroups of 15 patients below the mean. The order cancellation percentage is also decreasing. The average delay pre-intervention from MRI order placement to results uploaded was 67 days. In January 2022, we implemented a breast MRI nurse navigator to help acquire results and expedite scheduling. Post-intervention, the average delay has decreased to 38.5 days. Using XmR and S charts, we have also shown an increase in precision. Conclusions: Providing discrete, clickable options within the MRI order set reduced the number of cancellations due to incorrect verbiage. Early data suggests that the educational intervention improved the cancellation rate. Instituting a nurse navigator decreased both the delay and variability for the time from order placement to results received, which will reduce the delay to follow-up of non-benign findings.

104 Background: Patient education has been shown to improve clinical trial participation. Medically underserved, racial, and ethnic minorities have a lower participation rate in cancer clinical trials (CCT) than patients of high socioeconomic status (SES). Our comprehensive cancer center is notable for providing equal access to breast CCT (BCCT) through a private system (McNair) and a public safety net hospital system, Smith Clinic (SC). Our prior research has shown that SC cancer patients, who are 60% uninsured, predominantly low SES, and >80% racial minorities, are 40% less likely to enroll into BCCT compared to McNair patients who are > 95% insured and largely White. Methods: We developed a 7-minute video with testimonies of our current patients (who are of diverse racial and linguistic backgrounds) about their BCCT experience and testimonies of our research team discussing misconceptions surrounding BCCT and biospecimen collection. The video was designed to be culturally sensitive and used simplified terms in English, Spanish, and Vietnamese. We modified a validated questionnaire by UT Health San Antonio, Institute for Health Promotion Research to assess participants’ attitudes towards CCT participation before and after watching the video. We used a Wilcoxon Signed Rank test to measure the effect of the video on a 5-point Likert scale with 5 indicating “Extremely likely”, 3 “Moderately Likely” and 1 “Not Likely at all”. The primary outcome was a shift in likelihood of participation in a CCT by 1. Other outcomes included assessing the effects of English proficiency, residing in United States (US) for at least 10 years, race, stage of breast cancer diagnosis (high risk vs. early stage vs. metastatic disease) using Chi-squared tests. With 200 survey respondents, the study had 97% power to detect the desired primary outcome. The project was supported by a Pfizer education grant. Results: A total of 200 patients (73 at McNair and 127 at SC) watched the video and completed the surveys. 93 identified as Hispanic, 50 as African American, 14 as Asian, 47 as White, and 7 as other races. The mean pre-intervention score for likelihood of willingness to participate in a CCT was 3.34 (SD 1.45) at McNair and 2.81 (SD 1.28) at SC. The mean post-intervention score was 3.89 (SD 1.28) at McNair and 3.44 (SD 1.22) at SC. While the pre- and post-intervention scores were significantly different across the two sites (p = 0.01 and p = 0.015 respectively), the study did not meet its primary objective. English proficiency, residing in US for at least 10 years, race, and stage of breast cancer diagnosis were not significantly associated with the outcome. Conclusions: Our patient education video did not improve our patients’ willingness to participate in BCCT as much as we had hoped. This suggests that a comprehensive approach is required to improve our community’s engagement and close the disparity gap in BCCT enrollment.

e18547 Background: In an ideal world, the populations studied in cancer clinical trials (CCT) would be representative of the patients seen in clinic. Unfortunately, significant disparities exist in trial enrollment. Patients who are white, male, insured, or of high socioeconomic status (SES) are overrepresented in NCI-sponsored CCT. Despite data indicating equal willingness for participation in CCT across all racial groups, lack of access, cultural barriers, and social determinants of health contribute to poor accrual rates among racial and ethnic minority patients. The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) notably provides equal access to breast CCT at Smith Clinic (SC) within the Harris Health system and Baylor St. Luke’s Medical Center (BSLMC). The patient populations differ greatly at these two sites, with BSLMC serving > 95% insured, largely Caucasian patients, and SC serving 60% uninsured, mostly low SES patients, with > 80% racial and ethnic minorities. Despite equal access, patients at SC have a significantly higher CCT refusal rate. This retrospective cohort study aims to identify predictors of CCT refusal. Methods: We performed a retrospective review of a prospectively maintained database of new patients seen at DLDCCC dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCT. 366 patients were found to be eligible for CCT. Some patients were eligible for multiple CCT, so there were 431 total offers of CCT. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the observed differences in CCT enrollment rates. Results: In the BSLMC cohort, 61% (116/204) of eligible patients enrolled in a CCT, while in the SC cohort only 39% (74/227) of eligible patients elected to enroll in CCT. This difference was significant on univariate but not multivariate analysis. There were significant differences when comparing race and trial type in the overall patient set. On univariate analysis, SC patients, African American (AA) patients, Hispanic/Latino patients, and Spanish speaking patients were significantly more likely to decline CCT participation. However, on multivariate analysis, only the AA patient category was associated with enrollment refusal (odds ratio 0.261, 95% CI 0.116-0.563, p < 0.001). On both univariate and multivariate analyses, patients were significantly more likely to accept biobanking trials (multivariate: odds ratio 12.799, 95% CI 3.777-61.403, p < 0.001). Conclusions: Based on these findings, it is likely an oversimplification to assume that equal access will lead to a complete elimination of CCT disparities. Our AA patients were significantly less likely to agree to participate in clinical trials, challenging the commonly held view that lack of access is a major barrier. We are exploring interventions designed to improve our AA patient population’s views of trial enrollment.

e18532 Background: Patient education has been shown to improve clinical trial participation. Medically underserved, racial, and ethnic minorities have lower participation rate in cancer clinical trials (CCT) than patients of high socioeconomic status (SES). Our comprehensive cancer center is notable for providing equal access to breast CCT through a private system (Baylor McNair) and a public safety net hospital (Harris Health Smith Clinic). Our prior research has shown that breast cancer patients at Smith Clinic (SC) who are 60% uninsured, predominantly of low SES, and 80% racial and ethnic minorities are 40% less likely to enroll compared to McNair patients where patients are > 95% insured and largely Caucasian. Methods: We developed a 7-minute video consisting of current patients’ testimonies of their CCT experience along with the research team discussing misconceptions regarding CCT and biospecimen collection. The video was designed to be culturally sensitive and used simplified terms in English, Spanish, and Vietnamese. We modified a validated questionnaire by UT Health San Antonio, Institute for Health Promotion Research to assess participants attitudes towards CCT participation before and after watching the video. We used a Wilcoxon Signed Rank test for measuring the effect of the video on a 5-point Likert scale with 5 indicating “Extremely likely”, 3 “Moderately Likely” and 1 “Not Likely at all”. The primary outcome was a shift in stated likelihood of participation in a CCT by 1 point. Using Chi-squared test, we assessed whether English proficiency or residing in the United States (US) for more than 10 years affected the results. Patients’ reason for refusing CCT was documented. With 200 survey responders, the study had 97% power to detect the desired primary outcome. The project was supported by a Pfizer education grant. Results: A total of 200 patients (73 at McNair and 127 at SC) watched the video and completed the surveys. The mean pre-intervention score for likelihood of willingness to participate in a CCT was 3.34 (SD 1.45) at McNair and 2.81 (SD 1.28) at SC. The mean post-intervention score was 3.89 (SD 1.28) at McNair and 3.44 (SD 1.22) at SC. While the pre- and post- intervention scores were significantly different across the two sites (p = 0.01 and p = 0.015 respectively), the study did not meet its primary objective. There were also no significant differences in the willingness to participate in CCT with regards to time spent in the US or English proficiency. Most frequent reasons for refusal were concern about extra costs, extra time commitment and the need to discuss the trial with family members. Conclusions: Our in-house developed patient education video did not improve patients’ willingness to participate in CCT as much as we had hoped. This suggests that a comprehensive approach is required to improve our community’s engagement and close the disparity gap in the treatment and outcomes of breast cancer.

e18641 Background: There are two million female veterans across the United States, a number increasing by more than 18,000 per year. 1 in 8 women will be diagnosed with breast cancer in their lifetime, and studies have shown that servicewomen are 40% more likely to get breast cancer than civilians. The American Cancer Society (ACS) recommends screening MRI in women with 20-25% or greater lifetime risk of breast cancer, and both primary care physicians and oncologists are now ordering these more frequently. The Michael E. DeBakey Veteran’s Affairs Medical Center (MEDVAMC) performs screening mammograms and ultrasounds, but breast MRI is not currently available at the facility. Care in the Community arranges for veterans to obtain these studies at outside facilities. This is a complex process, requiring coordination among multiple departments, the outside MRI facility, and the patient. There are a significant number of MRI order cancellations per month, which can lead to delays in diagnosis or treatment. Methods: We created a comprehensive process map for the current breast MRI ordering process to determine areas for improvement. We looked at all breast MRI orders starting in 12/2020 at the MEDVAMC and determined the rate of cancellation and the rate of benign (BIRADS 1-2) vs non benign (BIRADS 0, 3-5) screening outcomes. We created a Pareto analysis to determine the most common cancellation reasons and p-charts of the percent of cancelled MRI orders per month and a run chart of the percent due to incorrect verbiage. Results: Of the 243 orders placed for MRI for 124 patients from 12/2020 to 1/2022, 64.2% were cancelled. Of the 57% of patients (71/124) with complete MRIs, 35.2% had non-benign findings requiring follow up, excluding known malignancies. Our Pareto analysis showed that most cancellations were due to incorrect verbiage in the order. An intervention in 6/2021 changed the MRI order from a free text box to clickable options, followed by an educational intervention in 12/2021. Cancellations due to incorrect verbiage decreased overall after June, however it has not yet reached significance. It is too early to determine if the educational intervention caused a significant change, however the cancellation rate has decreased. Conclusions: Providing discrete, clickable options within the MRI order has reduced the number of cancellations due to incorrect verbiage, though we have not yet reached significance. Early data suggests that the educational intervention has improved the cancellation rate. Fewer cancellations will lead to more timely studies, which will in turn lead to faster follow up of non-benign findings. Further directions include using a nurse navigator to reduce confusion and delays, further simplifying the ordering process, checking patient phone numbers in clinic, and sending patients home with information on the importance of screening MRI to reduce veteran cancellation.