Patel, Manali I.

ImportanceCancer imposes a substantial economic burden on patients that may be worse in patients with higher-stage disease due to the need for more therapy.ObjectiveTo investigate the out-of-pocket costs (OOPCs) attributable to the initial treatment of common cancers among privately insured individuals diagnosed at different stages.Design, Setting, and ParticipantsThis retrospective cohort study used administrative claims data of a large national insurer in the US linked to the Surveillance, Epidemiology, and End Results (SEER) cancer registry to compare OOPCs of individuals diagnosed with breast, colorectal, and lung cancer at different stages with OOPCs of similar individuals without cancer using difference-in-differences methods. Individuals living in the US between 2008 and 2022, aged younger than 65 years, insured through a large national private health insurer, and with 6 or more months of continuous enrollment were included. Data were analyzed from June 2024 through February 2025.ExposureThe presence or absence of an incident cancer diagnosis and disease stage from the SEER registry diagnosed from 2008 to 2019.Main Outcomes and MeasuresThe primary outcome was OOPCs among individuals with breast, colorectal, and lung cancer diagnosed at different disease stages compared with those with no cancer diagnosis.ResultsThe cohort consisted of 46 158 patients (mean [SD] age at diagnosis, 46 [12] years; 30 733 female [66.6%]; 2543 Asian [5.5%], 4114 Black [8.9%], 3590 Hispanic [7.8%], and 31 099 White [67.4%]), including 19 656 patients with cancer and 26 502 patients without cancer in the control group. Among patients with cancer, 14 581 patients had breast cancer, 2842 patients had colorectal cancer, and 2233 patients had lung cancer. An incident cancer diagnosis was associated with a mean increase in OOPCs of $592.53 per month (95% CI, $528.01-$627.04 per month) for the 6 months after the diagnosis. Cost monotonically increased with stage at diagnosis (mean OOPC increase range, $462.01 per month [95% CI, $417.92-$506.11 per month] for stage 0 to $719.97 per month [95% CI, $626.11-$813.83 per month] for stage 4).Conclusions and RelevanceIn this study of individuals with private insurance, patients faced high OOPCs after an incident diagnosis of cancer, with patients with more advanced cancer having the highest OOPCs. Further research is needed to determine the clinical and financial effects of increased OOPCs for patients with cancer.

Serious illness communications are crucial elements of care delivery for patients with cancer. High-quality serious illness communications are composed of open, honest discussions between patients, caregivers, and clinicians regarding patient's communication preferences, expected illness trajectory, prognosis, and risks and benefits of any recommended care. High-quality communication ideally starts at the time of a patients' cancer diagnosis, allows space for and response to patient emotions, elicits patients' values and care preferences, and is iterative and longitudinal. When integrated into cancer care, such communication can result in improved patient experiences with their care, care that matches patients' goals, and reduced care intensity at the end of life. Despite national recommendations for routine integration of these communication into cancer care, a minority of patients with cancer receive such communication. In this chapter, we describe elements of high-quality serious illness communication, patient-, clinician-, institution-, and payer-level barriers, and successful strategies that can routinely integrate such communication into cancer care delivery.

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.

175 Background: In 2009, ASCO confirmed that addressing cancer care disparities is critical for the Society and committed to approaches to eliminate such disparities. Yet, gaps remain in identifying the best approaches to do so. It remains unknown which cancer care providers serve patients from “underserved populations'' (defined as individuals who have historically received inadequate health care and health care services), what unmet needs they experience in their cancer care delivery, and how best to engage and support these providers. The objectives of this study were to explore challenges faced by providers serving underserved patients to inform development of a broader online survey and identify solutions that ASCO can implement to better support these providers. Methods: A multi-phase mixed-methods approach was utilized. Phase 1 involved key informant semi-structured interviews with 12 oncology providers caring for adult patients in the US from April to May 2021. Phase 2 involved survey development based on themes identified in Phase 1. The survey assessed: provider needs; processes for eliciting, documenting, and addressing social and economic needs of patients; and how ASCO could best support these providers. Phase 3 involved email distribution of the online survey in May 2022 to 5800 individuals identified through ASCO’s customer database. Eligibility criteria included providing care for adults with cancer in the US and prior consent to receive ASCO survey communications. Results: Of 477 respondents, the majority were ASCO members (88%), in an academic practice (57%), medical oncologists (77%), non-Hispanic (89%) and/or Caucasian/White (67%) and had > 15 years’ clinical experience (57%). A majority (60%) provided ≥25% of their clinical time providing cancer care to underserved populations and routinely engaged with administration to secure resources (61%) and local community organizations to obtain services (42%) for patients. Most (43-77%) indicated that a social worker/case manager was primarily responsible for addressing patient social needs. The majority reported that identification and dissemination of best practices (55%) and development of a return-on-investment business model (60%) would best help address patient needs. Some respondents expressed a desire to collaborate with ASCO on policy reform (32%) and for ASCO to help build or strengthen partnerships with local initiatives (29%). Conclusions: This is the first US-based survey assessing barriers and solutions to delivering cancer care among underserved populations. The findings from this work provide insights about how ASCO can help equip practices to address the social needs of their patients. Further work will be conducted to develop and implement suggested solutions.

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.

This report presents the American Society of Clinical Oncology’s (ASCO’s) evaluation of the adaptations in care delivery, research operations, and regulatory oversight made in response to the coronavirus pandemic and presents recommendations for moving forward as the pandemic recedes. ASCO organized its recommendations for clinical research around five goals to ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality. The specific goals are: (1) ensure that clinical research is accessible, affordable, and equitable; (2) design more pragmatic and efficient clinical trials; (3) minimize administrative and regulatory burdens on research sites; (4) recruit, retain, and support a well-trained clinical research workforce; and (5) promote appropriate oversight and review of clinical trial conduct and results. Similarly, ASCO also organized its recommendations regarding cancer care delivery around five goals: (1) promote and protect equitable access to high-quality cancer care; (2) support safe delivery of high-quality cancer care; (3) advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care; (4) recognize and address threats to clinician, provider, and patient well-being; and (5) improve patient access to high-quality cancer care via telemedicine. ASCO will work at all levels to advance the recommendations made in this report.