Boehmer, Leigh

Abstract Introduction: Triple-negative breast cancer (TNBC) presents unique challenges due to its aggressive nature and limited treatment options. Black women are disproportionately affected by TNBC, experiencing higher incidence rates and poorer outcomes compared to other racial/ethnic groups. This study aims to evaluate disparities in access to quality cancer care for Black women with TNBC from the perspective of oncology healthcare providers. Methods: From December 2022 to February 2023, the Association of Community Cancer Centers conducted a survey of 84 multidisciplinary care team members who provided care to Black patients with TNBC. The online survey captured quantitative and qualitative data on challenges related to accessing timely TNBC diagnosis and treatment services, care coordination for work-up and biomarker testing, confidence in TNBC treatment, clinical trial enrollment, supportive care services, and related referrals. Additionally, a follow-up focus group was conducted in May 2023 to further interpret select survey data, with a focus on shared decision-making, patient-provider communication, and ways to support cancer programs in improving screening, biomarker testing, and care coordination for individuals with TNBC. Results: Respondents reported several barriers to accessing timely diagnosis and treatment services for Black women with TNBC, including challenges in coordinating care for work-up and biomarker testing, providers' confidence in providing guideline-concordant comprehensive cancer care services for this patient population, enrolling patients in clinical trials, and making referrals for supportive care services. The survey revealed that community cancer programs treated an average of 21-50 patients with TNBC annually, with 31% of them being Black. Perceived patient-level factors contributing to challenges in accessing TNBC diagnosis and treatment included geographic distance to care facilities (14%), health literacy (18%), and insurance-related factors (21%). Practice-level barriers included limited accessibility of practice location (19%), capacity to accommodate new patients (27%), and insurance-related factors (34%). Additional findings highlighted slightly lower provider confidence in areas such as tobacco cessation (only 54% very confident), breast reconstruction (59% very confident), fertility counseling (52% very confident), and coordinating care across a fragmented healthcare system (52% very confident). Respondents identified the most commonly offered comprehensive cancer care services as palliative care (82%), nutrition support (77%), telemedicine (68%), psychological counseling (68%), and financial advocacy (68%). Less commonly offered services include recreational therapy (21%), legal aid (17%), and childcare (16%). Conclusion: This study highlighted the barriers faced by providers in delivering quality cancer care to Black women with TNBC. The findings underscore the importance of addressing challenges related to timely diagnosis and treatment services, care coordination, confidence in treatment options, clinical trial enrollment, and referrals for supportive care services. Insights from the focus group discussions further highlight the need for shared decision-making, improved patient-provider communication, and identification of opportunities to support cancer programs in addressing the specific needs of Black women with TNBC. To advance equity in cancer care, targeted interventions should focus on enhancing provider education, improving care coordination systems, and promoting cultural sensitivity. Efforts should also be made to overcome barriers related to limited accessibility of practice location, and insurance-related factors. By addressing these gaps, providers can play a crucial role in reducing disparities and improving outcomes for Black women with TNBC. Citation Format: Doreen Effange, Niharika Dixit, Ruth O'Regan, Ogori Kalu, Ryann Norcereto, Richard Simonds, Elizabeth Valencia, LaToya Bolds-Johnson, Aubrey Van Kirk Villalobos, Christie Mangir, Elana Plotkin, Karen Tacka, Leigh Boehmer. Evaluating Disparities in Access to Quality Cancer Care for Black Women with Triple Negative Breast Cancer in the US: A Provider Perspective [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-06-10.

This commentary is a call to action for a concerted commitment and effort to transform clinical trials and enable people with cancer to participate in clinical trials closer to home. Three key strategies are identified to address major barriers: confront challenges with the interpretation of US Food and Drug Administration Form 1572 requirements (Statement of Investigator); broaden acceptance of local laboratories and imaging centers; and invest in the creation of effective, sustainable partnerships between research centers and local providers.

Background: For patients with chronic lymphocytic leukemia (CLL)-the most common form of leukemia in older adults-equitable access to care is particularly challenging, as the disease is often diagnosed in community cancer centers encumbered by regional disparities. Therefore, identifying and understanding regional barriers to care is essential. In 2020, the Association of Community Cancer Centers (ACCC) developed a heat map detailing the incidence rate of CLL diagnoses across the country (Fig.1), overlayed with the locations of CLL “expert” providers, revealing the areas in the US most in need of additional CLL clinical expertise (Fig. 2). In 2022, these incidence rates were stratified by race, ethnicity, and metropolitan statistical area to identify disparities Building on these maps, ACCC set out to identify specific regional challenges to appropriate, equitable care for patients with CLL. Methods: As part of an independent education program, ACCC initiated conversations with providers about the regional barriers that patients with CLL face. Through 4 webinars in February 2023, participants from 4 regions-Northeast (New York and Maine), Northwest (Montana and Idaho), Midwest (Wisconsin, Illinois, and Iowa), and Southwest (Texas)-shared insights on challenges and exchanged ideas on strategies to improve care for patients with CLL. In addition, ACCC interviewed 3 regionally diverse cancer programs (from the US Northwest, South, and Southwest regions) that are effectively overcoming regional challenges to reach their patient populations and provide equitable care. These interviews highlighted barriers and challenges, showcased effective outreach campaigns, and explored how the outreach improved the patient journey. Findings: The following themes emerged as key challenges and potential solutions throughout all regions studied: (1) Comprehensive Diagnostic Work-up Before Treatment Initiation: A key component in caring for patients with CLL is identifying certain disease related criteria prior to formulating a treatment plan. This includes determining the disease burden, disease-related symptoms, and if the patient meets certain active disease criteria (eg, Binet Stage C or Rai Stage III or IV). Further, by utilizing genetic testing, such as the TP53 gene mutation and IGHV mutation tests, physicians can estimate time to treatment and choice of specific novel targeted therapies. (2) Understanding Patient Population Needs: Cancer programs must understand the needs of their unique patient populations to effectively address them. For example, in the Northwest, as mountainous passes can make travel dangerous at times, one local program utilizes near-campus housing/hotel space for patients for the duration of their intensive treatment. In the Southwest, addressing health insurance coverage, low health literacy, language barriers, patient-provider mistrust, and culturally competent care for undocumented individuals presents challenges to equitable care delivery. Therefore, cancer programs in this region have implemented protocols to utilize community and social services to help support these patients. (3) Developing Community Partnerships: As the median age of diagnosis with CLL is approximately 70 years old, barriers such as transportation availability, caregiver support and financial constraints could be magnified. Building trust, particularly among vulnerable communities, also presents a significant challenge. By partnering with community outreach organizations, programs can help address these issues through community resources such as ride share programs, transportation vouchers, and financial assistance programs. (4) Provider Education and Learning: Because many patients are diagnosed in community cancer programs and smaller practices where physicians do not often have experience with CLL, nationally available provider education on new developments in testing and treatments is key. Conclusions: ACCC identified regional challenges and solutions to appropriate and equitable care for patients with CLL, including the importance of comprehensive diagnostic work-up before treating, understanding the regional needs of patient populations (particularly underserved populations), building community partnerships, and engaging in targeted provider education.

Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) and helped identify specific strategies (63%) to increase EDI in trials. Although most sites (65%) were able to provide some data on the number of patients that consented, only two sites were able to provide all requested trial screening, offering, and enrollment data by race and ethnicity. Documenting and evaluating such data are critical steps toward improving EDI and are key to identifying and addressing disparities more broadly. ASCO and Association of Community Cancer Centers will partner with sites to better understand their processes and the feasibility of collecting screening, offering, and enrollment data in systematic and automated ways.

307 Background: In the US, more than 12,000 people die from ovarian cancer annually. Although new treatments have recently become available, ovarian cancer care delivery remains suboptimal. The Association of Community Cancer Centers (ACCC) developed a series of initiatives to improve the quality of care for patients with ovarian cancer. In Phase I, ACCC evaluated the needs of cancer programs, conducted 3 quality improvement (QI) workshops, and developed expert-driven Quality of Care recommendations to aid cancer programs in self-assessment and quality improvement. In Phase II, ACCC invited programs to self-assess their level of care using the Quality of Care recommendations. Methods: In 2022, ACCC surveyed 7 ovarian cancer programs across the US. Developed by a multidisciplinary expert steering committee, the 26-question survey assessed the patient populations served, services provided, diagnostic evaluations performed, access to molecular testing, and a self-assessment of quality care delivery and interest in conducting QI projects related to self-identified needs. The survey was administered in Qualtrics and summarized using descriptive statistics. Results: Surveys were completed by 1 community, 2 comprehensive community, 2 hospital-associated, 1 academic comprehensive, and 1 NCI-designated comprehensive cancer programs. The median annual ovarian cases was 40 [range: 2 to 68]. The 7 programs serve diverse racial/ethnic distribution of patients with ovarian cancer ranging from 55% Black to 60% Asian and 30% Pacific Islander. Five programs have a multidisciplinary team for ovarian cancer. All 5 multidisciplinary teams included gynecologic oncology and pathology; 3 teams also included medical oncology and or radiology colleague(s). Sites assessed their level of care for 7 domains of quality care from 1 (lowest) to 5 (highest). The average score was 4.0 for Care Coordination and Patient Education, Treatment Planning, and Disease Surveillance. Diagnosis and Initial Management scored on average 3.8, Equity in Care 3.25, Prevention and Screening 3.25, and Quality of Life 3.2. Sites ranked areas of interest for future QI projects (1 = area of most interest, 7 = area of least interest). The highest ranked domains were Care Coordination and Patient Education as well as Diagnosis and Initial management (average rankings 2.8). These were followed by Quality of Life (average 3.0), Prevention and Screening (Average 3.8), Treatment Planning (Average 4.4), Equity in Care (Average 5.0), and Disease Surveillance (Average 6.2). Conclusions: This assessment will be used to identify 4 additional sites for Phase II QI workshops. Findings from these projects will be combined, summarized, and disseminated to inform future education opportunities and QI initiatives. This initiative aims to help organize and standardize the care of patients with ovarian cancer and improve patient care coordination.

52 Background: When combination medical therapy incorporates both IV and oral anti-cancer agents, patients may experience compound side effects and face challenges with treatment adherence. To assess how community cancer programs may improve care coordination for patients receiving combination IV/oral systemic therapy, the Association of Community Cancer Centers (ACCC) conducted a mixed-methods study that involved healthcare professionals (HCPs), patients and caregivers. Methods: The study followed a sequential quantitative-qualitative design to answer questions around the barriers or challenges associated with combination IV/oral systemic therapy. The quantitative phase included an online survey of HCPs (by ACCC) and a survey of patients and caregivers (by Edge Research, in collaboration with several patient advocacy organizations). In the quantitative phase, the survey results were contextualized through two HCP focus groups and individual HCP interviews. Results: Comparing and contrasting the patient survey (n = 113) and HCP survey (n = 157) results revealed insights around the following themes: Top Challenges: Patients felt their top challenges were side effects (57.5%); inconvenience going to medical appointments (37.2%); and financial burden (36.3%). HCPs perceived top challenges as cost of care to the patient (24.0%); coordination and delivery of oral agents (22.1%); and health insurance coverage (21.9%). In focus groups, HCPs explained how they were investing significant staffing resources to prevent and mitigate financial toxicity, especially for patients receiving oral therapies. Methods of Communication: 35.4% of patients “highly preferred” using email to communicate with HCPs about their combination regimens. However, HCPs felt that email was one of the least effective methods of communicating with patients. In focus groups, HCPs agreed that email is convenient when communicating about non-urgent matters. However, they were concerned that some patients may use email to communicate about urgent issues. Treatment-related AEs: When patients experienced treatment-related AEs, 30.1% said their clinicians tried a dose modification or hold. HCPs had mixed perceptions regarding the effectiveness of dose holidays. Those who felt this was highly effective included: advanced practice providers (42.9%), nurses (28.1%); oncologists (16.7%); and pharmacists (16.7%). Conclusions: This study identifies opportunities to improve care coordination for patients receiving combination IV/oral systemic anti-cancer regimens. These findings may inform the creation and dissemination of effective practices and quality improvement projects. These results may also help cancer programs tailor resources and incorporate proactive steps to address some of the key challenges patients may face.

6530 Background: Only a small fraction of patients with cancer participate in treatment trials. Patients identifying as members of racial and ethnic minority groups are consistently underrepresented in these trials. A recent systematic review reported that patients, regardless of race and ethnicity, are willing to enroll in trials if asked to participate by their treating clinician. Prospective and longitudinal data and metrics at the site- and clinician-level are necessary to understand whether patients are equitably considered for clinical trials. Methods: ASCO and Association of Community Cancer Centers (ACCC) developed a self-assessment for trial sites to record and gauge the number of patients across races and ethnicities screened, offered, and enrolled into clinical trials. Research sites, from across the US, were recruited through an open call to apply to participate in the ASCO-ACCC Pilot Project. There were 65 sites assigned to this pilot study, which tested the feasibility and utility of the site assessment. Sites were asked to enter 2019 and 2020 aggregate data for each step along the clinical trial enrollment continuum by select races and ethnicities (Black, Hispanic/Latinx, White) and overall. Results: 62 of 65 sites completed the study and represented a range of settings and practice types (61% academic, 26% hospital/health system, 13% independent). Only 2 sites (3%) were able to provide the data requested at each enrollment step in the assessment (table). Sites that collected the data did not do so routinely (table) and most had to compile data through multiple sources and/or manual extraction (40-100% across enrollment steps). Sites with missing data reported they did not collect data at all (36-64% across enrollment steps), did not collect data in a systematic way (0-29% across enrollment steps), or stated it would be too burdensome to manually review charts to extract data (12-29% across enrollment steps). Conclusions: Data collection and routine evaluation of participation metrics, by race and ethnicity, are necessary to assess and monitor equity and diversity in clinical trials. Most sites in this study did not collect, or routinely collect, data for screening, offering, and consenting patients to clinical trials. Without these data, sites are unable to evaluate and monitor whether their patients have equitable access to clinical trials or establish strategies to address any inequities. ASCO and ACCC will continue to partner with sites to better understand their processes and the feasibility of collecting such data in a systematic and automated way, such as through electronic health record systems. [Table: see text]

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

256 Background: Ovarian cancer is the leading cause of gynecologic cancer mortality in the US. Given the high burden of disease and complexities in the provision of quality care, a multidisciplinary team approach is critical to optimal care delivery. In 2019, the Association of Community Cancer Centers (ACCC) launched a multiphase, stakeholder-driven initiative to improve care for this patient population. Results of a national survey of cancer programs to identify the needs of patients are reported here. Methods: A 20 question survey was developed by an expert steering committee including gynecologic oncologists, pathologists, genetic counselors, a nurse navigator, and cancer center administrators. The instrument was designed to collect data about cancer programs, key ovarian cancer patient needs, and barriers to and opportunities for improving ovarian cancer care. The online survey was open for participation for 4 weeks using the Qualtrics platform and distributed via email to ACCC and Society of Gynecologic Oncology members. Results: We received 26 total responses from Comprehensive Community (26%), NCI-Designed Comprehensive (22%), Academic Comprehensive (22%), and Integrated Network (13%) Cancer Programs. Annual ovarian cancer cases ranged from 22 to 190 (median: 50.5). 85% of programs has a multidisciplinary team for ovarian cancer and 61% were part of a referral network. On average, programs has 1.5 phase II and 2 phase III clinical trials currently available for ovarian cancer (all programs had at least 1 trial available). Palliative care and comprehensive symptom management was integrated into the first appointment (15%), integrated at the time of recurrence (4%), and most frequently, available by consult (81%). We assessed genetic testing practices at each program. Aggregated across programs, 79% of patients received germline multipanel testing, 71% germline BRCA only, 50% somatic multigene, and 51% somatic BRCA only. The frequency of consultations included: genetic counseling (75%), nurse navigation (75%), social work (50%), dietetics (40%), financial counseling (25%). Genetic evaluations were typically ordered by Gynecologic Oncology (88%), genetic counseling (4%), or both (8%). When asked what topic they would choose for a quality improvement project, genetic testing and counseling was the most frequent choice (46%), followed by clinical trials enrollment and availability (23%), multidisciplinary team care (19%), education on best practices (15%), palliative care (15%), and ancillary services (15%). Conclusions: Multidisciplinary care for ovarian cancer was common across a range of cancer programs but integration of palliative care, social work, dietetics, and financial counseling could be improved. Expanding clinical trials and genetic testing and counseling were the most frequently identified opportunities to improve ovarian cancer care.