Cancer Clinical Trial Enrollment Research Articles

Abstract PO2-03-02: Technology-enabled identification of low-risk breast cancer survivors for personalized survivorship care

Abstract Background. Advancements in cancer medicine have resulted in prolonged survival for the majority of patients. Personalized care pathways which account for clinical needs of this growing population of cancer survivors—and which address oncology workforce shortages—are urgently needed. Rapid identification of low-risk cancer survivors who could be cared for in other settings is a critical element of personalized care. Here we present final algorithm performance on risk-stratification from an ongoing clinical trial evaluating a primary care physician-led cancer survivorship clinic for breast cancer survivors. We captured data on real-time clinical risk stratification of early-stage patients between 6-36 months post-treatment. Methods. With oncology stakeholder input, we developed a screening algorithm to identify low-risk breast cancer survivors from the electronic medical record based on data from pathology, treatment, and utilization records. The algorithm identified patients meeting study eligibility: adult stage 0-IIb breast cancer patients diagnosed with first primary cancer, excluding those with treatments indicative of high-risk or metastatic disease, ongoing ovarian suppression, neoadjuvant therapy, or enrollment in other cancer clinical trials. Next, the treating oncologist was asked to confirm or deny patient eligibility; if denied, we tracked and categorized the reason provided for ineligibility. We describe: 1) characteristics and proportions of patients identified by the algorithm; 2) a breakdown of patients confirmed or denied eligibility; and 3) oncologists’ reasons for ineligibility. Results. The algorithm identified 1186 patients. Of those, 91 were flagged by oncology as not followed (e.g., consult only), and 204 were not categorized. Of the remaining 890 patients, 716 (81%) were categorized as eligible. Mean age was 62 years (SD: 11.4, Table 1). There were significant differences by stage, with a higher proportion of stage 0 in the eligible group (24% vs. 18%) and a lower proportion of stage II (24% vs. 35%). There was also a significant difference by HER2 status, with a greater proportion of HER2+ patients categorized as eligible (21% vs. 16%). There were significant differences by race/ethnicity, with a higher proportion of Asian and Black patients categorized eligible (14% vs. 8%, and 28% vs. 17%, respectively) and fewer Hispanic and White patients categorized eligible (26% vs. 36%, and 30% vs. 37%, respectively). There were not significant differences by ER/PR, surgery, or endocrine therapy. Reasons for ineligibility included: suspicious for recurrence (6%), new primary disease (3%), considered high-risk based on genetic/tumor factors (9%), co-occurring heme/oncology disorder (9%), treatment-related concerns (e.g., patient declined chemotherapy) (7%), complex case/condition (11%), patient preference per conversation with oncologist (32%), other (19%), and lost to follow-up (4%). Conclusions. Leveraging technology to support survivorship in the primary care setting is critical. Our findings demonstrate that consensus-based risk algorithms with oncologist review can effectively perform identification of low-risk patients who may be appropriately transitioned to other settings for survivorship care. These patients may benefit from primary care-led survivorship with a focus on healthy lifestyle, managing comorbid conditions, and psychosocial care. Eligible/Ineligible per oncologist by patient demographics and cancer characteristics Citation Format: Farah Brasfield, Aiyu Chen, Eric Haupt, Lindsay Lyons, Talar Habeshian, Corrine Munoz-Plaza, Ernest Shen, Huong Nguyen, Michael Gould, Alexander Ferreira, Allen Joo, Seyed Monemian, Christy Lai, Yung-Mee Park, Hollis Lee, Steven Steinberg, Patricia Ganz, Erin Hahn. Technology-enabled identification of low-risk breast cancer survivors for personalized survivorship care [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 PO2-03-02.

Abstract PO5-10-06: A Pilot Study for Clinical Research Nurse Navigation at an Urban NCI-Designated Comprehensive Cancer Center

Abstract Background: Breast cancer is now the leading cause of cancer death for non-Hispanic Black women in Georgia with non-Hispanic Black women 40% more likely to die of breast cancer compared to White women. Inadequate representation of patients in clinical trials may contribute to health care inequity, though prior work has also shown disparate outcomes on similar clinical trials at Emory, suggesting differences in tumor biology may also be contributing to the disparity. Improving diversity in trial participation is imperative to better understand these differences, particularly with newer molecularly targeted therapies. We aimed to utilize Clinical Trials Nurse Navigation to increase clinical trial enrollment at an urban NCI-designated comprehensive care center in Atlanta, Georgia. Methods: A prospective pilot study was conducted investigating the role of a Clinical Research Nurse as a dedicated Clinical Trials Nurse Navigator to identify, pre-screen, and refer potential patients to both breast and next generation sequencing (NGS)-driven basket clinical trials at the Winship Cancer Institute at Emory University. The role also included centralizing all molecular data from patients with stage IV breast cancer into a database as a tool to refer patients to NGS-driven clinical trials. This role expands upon the Institute’s current research nursing scope to better meet the needs of our diverse patient population. Our catchment area is 35% non-Hispanic Black or African American. The nurse prescreened patients with stage IV breast cancer from breast oncology clinic templates and the breast NGS database to match them with clinical trials, with a particular emphasis on patients with stage IV triple negative breast cancer. The study began in January 2022 and is currently ongoing. Results: Since study initiation in January 2022, there has been a 27% increase in breast cancer clinical trial enrollment over a 12-month period. Over the last 6 months from January 2023, this has increased even further with 57 patients enrolled onto breast cancer clinical trials compared to a total enrollment of 70 patients onto breast cancer clinical trials in 2022 (Table 1). Of these patients, 11% enrolled in NGS-driven clinical trials in 2022 to present compared to 0% in 2021. Twenty-two (31.4%) non-Hispanic Black women enrolled onto breast cancer clinical trials in 2022 with another 21 (36.8%) non-Hispanic Black women enrolled thus far in 2023 (Table 1). Conclusion: Disparities in clinical trial enrollment may contribute to racial inequities in breast cancer outcomes. Implementation of clinical research nurse navigation has successfully improved clinical trial enrollment and diversity in clinical trial enrollment at our urban cancer center. Through increasing clinical trial prescreening, centralizing an NGS database, and dedicated nurse support to allow patients to navigate onto clinical trials, we achieved a 21% improvement in clinical trial enrollment from 2021 to 2022 and are on track to increase enrollment by 200% by the end of 2023. Clinical trials nurse navigators serve as an essential link between clinical trial patients and their providers, and should strongly be considered a key component of all clinical trials programs. Table 1 Breast Working Group Patient Enrollment by Race and Ethnicity, 2019-2023 Citation Format: Lizzie Huckaby, Maisey Ratcliffe, Madison Canning, Demetria Smith-Graziani, Kevin Kalinsky, Manali Bhave. A Pilot Study for Clinical Research Nurse Navigation at an Urban NCI-Designated Comprehensive Cancer Center [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 PO5-10-06.

Barriers to Clinical Trial Implementation Among Community Care Centers

While an overwhelming majority of patients diagnosed with cancer express willingness to participate in clinical trials, only a fraction will enroll onto a research protocol. To identify critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment. This survey study included designated site contacts at oncology practices with teams who were highly involved with the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute (ACORI) clinical trials activities, all American Society of Clinical Oncology (ASCO)-ACCC collaboration pilot sites, and/or sites providing care to at least 25% African American and Hispanic residents. To determine participation trends among health care practices in oncology-focused research, identify barriers to clinical trial implementation and operation, and establish unmet needs for cancer clinics interested in trial participation, a 34-question survey was designed. Survey questions were defined within 3 categories: cancer center demographic characteristics, clinical trial characteristics, and referral practices. The survey was distributed through email and was open from June 20 through October 5, 2022. Participation in and barriers to conducting oncology trials in different community oncology settings. The survey was distributed to 100 cancer centers, with completion by 58 centers (58%) across 25 states. Fifty-two centers (88%) reported that they conduct therapeutic clinical trials, of which 33 (63%) were from urban settings, 11 (21%) were from suburban settings, and 8 (15%) were from rural settings. Only 25% of rural practices (2 of 8) offered phase 1 trials, compared with 67% of urban practices (22 of 33) (P = .01). Respondents noted challenges in conducting research, including patient recruitment (27 respondents [52%]), limited staffing (27 [52%]), and nonrelevant trials for their patient population (25 [48%]). Among sites not offering therapeutic trials, barriers to research conduct included limited infrastructure, funding, and staffing. Most centers (46 of 58 [79%]) referred patients to outside centers for clinical trial enrollment, particularly in the context of late-stage disease and/or disease progression. Only 17 of these sites (37%) had established protocols for patient follow-up subsequent to outside referral. In this national survey study of barriers to clinical trial implementation, most sites offered therapeutic trials, but there were significant disparities in trial availability across care settings. Furthermore, fundamental deficiencies in trial support infrastructure limited research activity, including within programs currently conducting research as well as at sites interested in future clinical research opportunities. These results identify crucial unmet needs for oncology clinics to effectively offer clinical trials to patients seeking care.

Disparities in clinical trial enrollment at a Canadian comprehensive cancer center: A 15-year retrospective study.

Disparities in clinical trials (CTs) enrollment perpetuate inequities in treatment access and outcomes, but there is a paucity of Canadian data. The objective of this study was to examine disparities in cancer CT enrollment at a large Canadian comprehensive cancer center. Retrospective study of CT enrollment among new patient consultations from 2006 to 2019, with follow-up to 2021 (N=154,880), with the primary outcome of enrollment as a binary variable. Factors associated with CT enrollment were evaluated using multivariable Bayesian hierarchical logistic regression with random effects for most responsible physician (MRP) and geography, adjusted for patient characteristics (sex, age, language, geography, and primary care provider [PCP]), area-level marginalization (residential instability, material deprivation, dependency, and ethnic concentration), disease (cancer site and stage), and MRP (department, sex, language, and training). A sensitivity analysis of the cumulative incidence of enrollment was conducted to account for differences in disease type and follow-up length. CT enrollment was 11.2% overall, with a 15-year cumulative incidence of 18%. Lower odds of enrollment were observed in patients who were female (adjusted odds ratio [AOR], 0.82; 95% confidence interval [CI], 0.78-0.86), ≥65 years (AOR vs.<40, 0.61; 95% CI, 0.56-0.66), non-English speakers (0.72; 95% CI, 0.67-0.77), living ≥250 km away (AOR vs.<15 km, 0.71; 95% CI, 0.62-0.80), and without a PCP. Disease characteristics accounted for the largest proportion of observed variation (20.8%), with significantly greater odds of enrollment in patients with genitourinary cancers and late-stage disease. Significant sociodemographic disparities were observed, suggesting the need for targeted strategies to increase diversity in access to cancer CTs in Canada.

Race/ethnic associations with comprehensive cancer center access and clinical trial enrollment for acute leukemia.

Clinical trial participation at Comprehensive Cancer Centers (CCC) is inequitable for minoritized race/ethnic groups with acute leukemia. CCCs care for a high proportion of adults with acute leukemia. It is unclear if participation inequities are due to CCC access, post-access enrollment, or both. We conducted a retrospective cohort study of adults with acute leukemia (2010-2019) residing within Massachusetts, the designated catchment area of the Dana-Farber/Harvard Cancer Center (DF/HCC). Individuals were categorized as non-Hispanic Asian (NHA), Black (NHB), White (NHW), Hispanic White (HW), or Other. Decomposition analyses assessed covariate contributions to disparities in (1) access to DF/HCC care and (2) post-access enrollment. Of 3698 individuals with acute leukemia, 85.9% were NHW, 4.5% HW, 4.3% NHB, 3.7% NHA, and 1.3% Other. Access was lower for HW (age- and sex-adjusted OR 0.64 95%CI 0.45,0.90) and reduced post-access enrollment for HW (aOR 0.54 95%CI 0.34,0.86) and NHB (aOR 0.60 95%CI 0.39,0.92) compared to NHW. Payor and socioeconomic status (SES) accounted for 25.2% and 21.2% of the +1.1% absolute difference in HW access. Marital status and SES accounted for 8.0% and 7.0% of the -8.8% absolute disparity in HW enrollment; 76.4% of the disparity was unexplained. SES and marital status accounted for 8.2% and 7.1% of the -9.1% absolute disparity in NHB enrollment; 73.0% of the disparity was unexplained. A substantial proportion of race/ethnic inequities in acute leukemia trial enrollment at CCCs are from post-access enrollment, the majority of which was not explained by sociodemographic factors.

Abstract 4824: Multi-level intervention to increase minority cancer patient enrollment to clinical treatment trials- Study design considerations and baseline characteristics from the ACTWONDER2S Study

Abstract Introduction: Black/African American (AA) and Hispanic cancer patients are underrepresented in cancer clinical trials (CCTs). Disparities stem from multiple factors, thus, comprehensive, multi-level interventions (MLI) are needed. Presented here is a conceptual framework for selecting the appropriate study design for MLIs using ACTWONDER2S, a multi-level intervention (MLI) aimed to increase Black/AA and Hispanic patient participation into CCTs, as an illustrative example. Baseline characteristics of the ACTWONDER2S target populations are also provided. Methods: ACTWONDER2S integrates community health educator and digital tools into an MLI targeting community residents and physicians in the Moffitt Cancer Center (MCC) catchment area, as well as MCC patients, physicians and CCT coordinators. A literature review of the relative strengths and weakness of 5 candidate designs for MLIs was conducted, and a cluster stratified randomized design was selected. Geospatial analytics were used to identify clusters of census tracts (“priority zones”) with high Black/AA and Hispanic populations for intervention deployment. Baseline characteristics of the priority zones were described using US Census data and other sources. Results: 14 priority zones were identified, which were matched on population characteristics and randomized into intervention (n=7) and control (n=7) zones. There were no statistically significant differences between the intervention and control priority zones in total population size (paired t-test p-value=0.63), proportions of Black/AA (p=0.133) and Hispanic populations p=0.17), and distance (in miles) from MCC (p=0.64). Approximately 35.8% and 16.5% of the intervention priority zones were Hispanic or Black/AA, respectively. Average distance to MCC, cancer cases, referral and CCT enrollment rates were also similar between groups. Conclusion: Decision frameworks for MLI study design selection are lacking. The framework provided here for ACTWONDER2S can be applied to other studies seeking to evaluate MLIs. Furthermore, the randomization of the priority zones produced optimal target populations for testing the efficacy of the MIL within ACTWONDER2S. Citation Format: Dana E. Rollison, Rossybelle P. Amorrortu, Lindsay N. Fuzzell, Melany A. Garcia, Elliott S. Tapia-Kwan, Yayi Zhao, Steven A. Eschrich, Bob R. Gore, Brian S. Mittman, Nathanael B. Stanley, Susan T. Vadaparampil. Multi-level intervention to increase minority cancer patient enrollment to clinical treatment trials- Study design considerations and baseline characteristics from the ACTWONDER2S Study [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 4824.

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.

Abstract PR01: Implementation of a real-time AI-guided navigation service for pancreas cancer

Abstract Patient navigation aims to overcome access barriers and optimize care delivery, but navigators cannot identify pre-diagnosed patients using traditional methods, hindering navigation efficacy. We observed care gaps among patients identified at our institution with suspected pancreatic cancer during January 2023: among 67 patients with new pancreas cancer, only 36% underwent biopsy with 22 days between radiology and biopsy; and 30% were seen by an outpatient oncologist with 32 days between radiology and visit. We sought to improve patient care outcomes through daily prospective AI-guided identification and navigation of patients with radiographic findings suspicious for pancreas cancer. In June 2023, we implemented an AI-guided daily workflow using the following steps: 1) at 24-hour intervals, an NLP model reviewed abdominal imaging reports and flagged reports containing language suspicious for pancreatic cancer; 2) a trained coordinator and GI oncologist validated reports with new masses and sent such reports to a GI navigator, and 3) the navigator facilitated appointments for proper follow-up, including GI services, the multi-disciplinary tumor board, and clinical trial coordinator. During June 2023, the model identified 69 patients with suspicion for new pancreas cancer. 19% were immediately eligible for navigation and scheduled for follow-up within our institution with an average of 8 days between report and navigation - 77% saw an outpatient oncologist with an average of 17.5 days between report and visit, 69% underwent biopsy with an average of 4.5 days between report and biopsy, and 54% were seen at multidisciplinary pancreatic cancer tumor board (pcTB) with an average of 16 days between report and pcTB. Furthermore, of these, we were able to enroll 4 patients to clinical trials and 5 accruals to biospecimen studies during this one-month period. 2 of these accruals were to the P-1000 study, which has been open at our institution for the last 2 years with a 0.5 per month accrual rate. Of the 81% who were not immediately eligible for navigation, 23% were already established with an oncologist in our system, 23% sought care elsewhere, 23% were not eligible for or did not desire further workup, and 30% were still undergoing in-patient workup. We show that an AI-guided workflow can transform referral patterns of pre-diagnosed pancreatic cancer patients, creating a new access stream for navigators to intervene much earlier in a patient’s continuum of cancer care with resultant improvement in healthcare delivery, evidenced by an average of 4.5 days between imaging and biopsy and 17.5 days between imaging and outpatient oncology visit, compared to our traditional cancer care approach with averages of 22 and 32 days, respectively. Furthermore, we have rapidly accelerated pancreas cancer clinical trial enrollment and biospecimen accrual at our institution since implementation of this workflow with 4 patients enrolled and 5 biospecimen accruals in a month alone. We are now working to expand this innovative framework across additional cancer types. Citation Format: Kristen M. John, Joseph Tenner, Yuddy Franco, Rolando Croocks, Melissa Perez, Tara McEvoy, Tiffany Zavadsky, Kristen Beyer, Rita Mercieca, Sandeep Nadella, Anthony Carvino, Matthew Barish, Daniel A. King. Implementation of a real-time AI-guided navigation service for pancreas cancer [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Pancreatic Cancer; 2023 Sep 27-30; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(2 Suppl):Abstract nr PR01.

Population-Based Data Linkage Describing Patterns of Cancer Clinical Trial Enrollment Among Children and Adolescents.

Database linkage between cancer registries and clinical trial consortia has the potential to elucidate referral patterns of children and adolescents with newly diagnosed cancer, including enrollment into cancer clinical trials. This study's primary objective was to assess the feasibility of this linkage approach. Patients younger than 20 years diagnosed with incident cancer during 2012-2017 in the Kentucky Cancer Registry (KCR) were linked with patients enrolled in a Children's Oncology Group (COG) study. Matched patients between databases were described by sex, age, race and ethnicity, geographical location when diagnosed, and cancer type. Logistic regression modeling identified factors associated with COG study enrollment. Timeliness of patient identification by KCR was reported through the Centers for Disease Control and Prevention's Early Case Capture (ECC) program. Of 1,357 patients reported to KCR, 47% were determined by matching to be enrolled in a COG study. Patients had greater odds of enrollment if they were age 0-4 years (v 15-19 years), reported from a COG-affiliated institution, and had renal cancer, neuroblastoma, or leukemia. Patients had lower odds of enrollment if Hispanic (v non-Hispanic White) or had epithelial (eg, thyroid, melanoma) cancer. Most (59%) patients were reported to KCR within 10 days of pathologic diagnosis. Linkage of clinical trial data with cancer registries is a feasible approach for tracking patient referral and clinical trial enrollment patterns. Adolescents had lower enrollment compared with younger age groups, independent of cancer type. Population-based early case capture could guide interventions designed to increase cancer clinical trial enrollment.

Effects of socioeconomic status on enrollment in clinical trials for cancer: A systematic review.

To achieve equitable access to cancer clinical trials (CCTs), patients must overcome structural, clinical, and attitudinal barriers to trial enrollment. The goal of this systematic review was to study the relationship between socioeconomic status (SES), assessed either by direct or proxy measures, and CCT enrollment. The review team and medical librarian developed search strategies for each database to identify studies for this systematic review, which was conducted according to PRISMA guidelines. Inclusion criteria were as follows: studies published in relevant scientific journals between January 2000 and July 2022, primary sources, English literature, and studies conducted in the US. Sixteen studies fulfilled the inclusion criteria and were reviewed. The risk of bias assessment was conducted independently by two reviewers using the Newcastle Ottawa scale. The initial search yielded 4070 citations, and 16 studies were included in our review. Four of the studies included used patient reported annual income as a measure of SES, while the remaining 12 studies used patient zip code as a proxy measurement of SES. Consistent with our hypothesis, 13 studies showed a positive association between high SES (patient-reported or proxy measurement) and CCT enrollment. Two studies showed a negative association, and one study showed no relationship. The existing literature suggests that low SES is associated with lower participation in CCT. The small number of studies identified on this topic highlights the need for additional research on SES and other barriers to CCT participation.

Disparities in Lung Cancer Clinical Trial Discussion and Enrollment at a Safety Net Hospital

Background In the United States, less than 5% of all adult cancer patients enroll in clinical trials. Few studies explore participation in cancer clinical trials at safety net hospitals, which disproportionately care for minoritized, low-income, uninsured, and underinsured populations. Our study aims to investigate disparities in clinical trial discussions and enrollment among lung cancer patients at Boston Medical Center, the largest safety net hospital in New England. Methods We included 1121 patients diagnosed with lung cancer between January 2015 and December 2020. Electronic Medical Records (EMR) were queried, and patients were categorized into three groups: (1) clinical trial discussed and the patient enrolled, (2) clinical trial discussed but the patient not enrolled, and (3) clinical trial not discussed. Sociodemographic variables such as age, gender, race, ethnicity, city, primary language, median household income, medical insurance type, and education level were also collected. Chi-squared, t test, and multivariate regression analysis was done using SPSS version 26.0. Results Of the 1121 patients, clinical trials were discussed in 141 patients (12.6%), of which 22 (15.6%) were enrolled. Clinical trial discussions were conducted more with younger patients (68.19 vs 71.37, p = .001), but on multivariate analysis there was no significant difference (OR = 1.023; 95% CI 0.998-1.048; p = .068). There was no significant difference in clinical trial discussion or enrollment between the other sociodemographic factors. Conclusion Additional study of barriers to cancer clinical trial discussion and enrollment at safety net institutions can serve as a prerequisite to ameliorating racial disparities observed on a national scale.

Abstract IA028: Achieving health equity: Inclusive participation in clinical trials

Abstract Minority participation in clinical trials is imperative to develop new prevention, detection, and treatment modalities for cancer because study samples must be representative to generalize findings to the disease population. As of 2020, low-SES populations, which have minority race/ethnicity prevalence, saw significantly greater risk from cancer mortality than their White, higher-income counterparts. This population has higher mortality from breast cancer (+10%), prostate cancer (+16%), colorectal cancer (+17%), and liver cancer (+26).1-2 Myriad drivers of health inequities3 act as barriers to clinical trial participation.1 Patient barriers include sociocultural and physical environment factors, while physician’ barriers include perceived loss of control, uncertainty, and lack of time to discuss research options.1 For example, 87% of patients surveyed in 2020 reported never having been invited to participate in a clinical trial with 41% not knowing anything about clinical trials; 9% had been asked, with &amp;lt;5% participating. Disparities were evident by minority race, low education level and income, and rurality.1,4 Retention and compliance barriers included participants’ loss of interest in the study, not having been assigned to a desired treatment, older age, low education, unemployment, and logistical barriers, such as transportation and child-care.4-5 Incorporating patient navigation programs into clinical trials helps correct for misinformation and builds trust between researchers and community members.5-7 The Increasing Minority Participation in Clinical Trials (IMPaCT) study (2007-2014, N=272), trained lay patient navigators (PNs) to guide patients through the eligibility process to enroll in cancer clinical trials at UAB. PNs also provided tailored support, including assistance with transportation and lodging, appointment reminder calls, social service referrals as appropriate, and linking patients with peer support. African American participation in therapeutic cancer clinical trials increased from 9% to 16%.4,6 UAB has had similar success with other patient navigation and health coaching studies, confirming PN benefits.8-10 An often overlooked barrier is researcher or physician implicit bias and the role bias plays in study design, particularly with regard to participant recruitment.11 Although everyone has biases, acknowledging how those biases affect our judgement and behaviors can be uncomfortable to process.12 When we address bias directly and take purposeful actions to mitigate implicit bias, patients benefit, enrollment increases among the populations most at risk, and results become generalizable.13-14 With the increasing amount of readily-available population-level data on incidence and mortality from various types of cancer registries, likely barriers to participation, including both patient-and researcher-centered, can be identified early in a study’s development and addressed during plan development. Finally, incorporating patient navigation into recruitment plans will enhance enrollment in cancer clinical trials. Citation Format: Mona N. Fouad. Achieving health equity: Inclusive participation in clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr IA028.

Abstract A128: A novel approach to understanding disparities in cancer clinical trial enrollment

Abstract Background: Cancer patients who participate in clinical trials have access to novel therapies, increased monitoring, and potentially improved survival. However, this access is not universal. Striking disparities in clinical trial enrollment have been linked to race, sex, and geography. However, studies on this topic are limited due to a lack of patient-specific socioeconomic data. Methods: This analysis used a novel linkage of administrative patient data from University Hospitals Seidman Cancer Center (Cleveland, Ohio) linked to the LexisNexis Socioeconomic Health Attributes, a robust dataset containing 442 patient-specific attributes gathered from public records regarding income, education, housing stability, property ownership and value, social support, and many others. We included cancer patients aged 18-75 years at the time of the latest cancer diagnosis (before trial enrollment if patient was enrolled) during 2007-2022. Because of the substantial differences in the demographic and clinical characteristics between the trial and non-trial patients, we applied the propensity score matching technique to one-to-one match all trial patients to non-trial patients by age, sex, race/ethnicity, cancer type, and year of the latest cancer diagnosis. Next, we applied the classification and regression tree (CART) machine learning algorithm to identify “phenotypes”, or combinations of patient socioeconomic characteristics that predict their trial enrollment status. We additionally performed the random forest algorithm to determine whether our CART model captured the most important variables in predicting trial enrollment. Results: We identified 28,671 cancer patients with a mean and median age of 60 and 62 years. Of those, 2,479 patients were enrolled in trials, and a corresponding 2,479 non-trial patients were matched. We identified 9 phenotypes of trial enrollment from the results of CART. The percentage of patients enrolled in trials ranges from 30% to 80%. Patients belonging to the highest-enrollment phenotype were identified by their estimated annual income exceeding $50,000, higher fraud-risk level, and age under 61 years. Patients falling into the lowest-enrollment phenotype were characterized by an estimated annual income below $30,000, an estimated home value below $243,000, and no college attendance. Variables identified by CART were also among the top-ranked variables in the random forest regarding their variable. Other important variables identified by random forest include, whether the patient ever registered to vote, risk of not being motivated to manage one's own health, and business records. Conclusion: Compared to community-level data, the use of patient-specific socioeconomic data provides a more granular understanding of clinical trial disparities. The use of machine learning methods of CART and random forest offers a promising avenue for future disparities research. This novel approach will deepen our understanding of cancer disparities and improve our ability to intervene and improve care for our most vulnerable patients. Citation Format: Weichuan Dong, Jamie Shoag, Tamila Kindwall-Keller, Ali Kara, John Shanahan, Debora Bruno, Johnie Rose, Siran Koroukian, Richard Hoehn. A novel approach to understanding disparities in cancer clinical trial enrollment [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A128.

Abstract A054: Leveraging the power of Hope Leaders for enhancing diversity in clinical trials via a bi-directional cancer health information model

Abstract Introduction: Despite increasing recognition of the need for diversity in clinical trials, participation from racial and ethnic minorities, particularly from low socioeconomic communities, remains dismally low. This underrepresentation hinders the generalizability of trial results and perpetuates health disparities. Low socioeconomic environments, characterized by economic instability, restricted healthcare access, food scarcity, and deficient educational resources, exacerbate these challenges. Residents of such communities often lean on "Hope Leaders" - trusted community figures - as a strategy to navigate through these adversities. Recognizing the pivotal role of these Hope Leaders, we advocate for a community-centered bi-directional cancer health information flow model, which positions these Leaders at the core of community engagement endeavors. This model fosters a bi-directional health information exchange that synergizes Hope Leaders with the scientific community, thereby promoting improved health equity within clinical intervention research. The implementation of this model commences with a pre-engagement phase, a respectful approach where we familiarize ourselves with the community and its dynamics, without imposing any specific demands or expectations. Approach: The University of Illinois Cancer Center has had 6 community engagement specialists that have engaged with community members through numerous pre-engagement events that encompass activities ranging from mental health, cancer prevention, survivorship events, education, health fairs and community meetings. Based on these insights, we established a dedicated working group to identify hope leaders and to create targeted engagement strategies for specific areas of our catchment region through the bi-directional cancer health information flow model. These strategies are tailored to address the unique challenges and barriers these communities face regarding enrollment in cancer clinical trials. Additionally, the community-driven health communication model was implemented to identify Hope Leaders and engage them with cancer researchers as a part of our phase I activities for this model. Conclusion: This innovative approach aims to leverage the unique position of Hope Leaders in underserved communities to amplify community voices, improve engagement, and ultimately, increase minority representation in cancer clinical trials. The model provides a promising strategy to address the persistent disparity in clinical trial participation, facilitating more equitable and inclusive research outcomes. Citation Format: Joseph Dufraine, Yamile Molina, Jeanette Gonzalez, Maria Olivero, Theresa Mobley, Saria Lofton, Dedra Reis. Leveraging the power of Hope Leaders for enhancing diversity in clinical trials via a bi-directional cancer health information model [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A054.

National enrollment of lung cancer clinical trials is disproportionate based on race and health care access

Despite declining lung cancer mortality in the United States, survival differences remain among racial and ethnic minorities in addition to those with limited health care access. Improvements in lung cancer treatment can be obtained through clinical trials, yet there are disparities in clinical trial enrollment of other cancer types. This study aims to evaluate disparities in lung cancer clinical trial enrollment to inform future enrollment initiatives. We analyzed patients with non-small cell lung cancer from the National Cancer Database (2004-2018), categorizing them as enrolled or not enrolled in clinical trials based on "rx_summ_other" data element. Clinical, demographic, and institutional factors associated with trial enrollment were assessed using bivariate and multivariate analysis, adjusting for institutional-level clustering. A total of 1924 (0.12%) patients with lung cancer were enrolled in clinical trials. Enrolled patients were predominantly non-Hispanic White (82%), with greater socioeconomic status, treated at academic programs (67%), and had private insurance (42%) or Medicare (44%). They also traveled further for treatment compared with unenrolled patients (56 vs 27 miles, P<.001). After adjusting for demographic and clinical factors, lung cancer trial enrollment was significantly less likely among Black (odds ratio, 0.55; 95% confidence interval, 0.5-0.7, P<.001) and Hispanic (0.66; 95% confidence interval, 0.5-0.9, P=.01) patients. Patients with Medicaid or uninsured, in the lowest socioeconomic status group, and those treated at community-based cancer programs were the least likely to enroll. Enrollment in lung cancer trials disproportionally excludes minority patients, those in the lowest socioeconomic status, community cancer programs, and the underinsured. These disparities in demographic and access for trial participation show a need for improved enrollment strategies.

Perceptions and Practices of Clinical Trial Enrollment Among Patients with Non-Hodgkin Lymphoma, Caregivers, and Providers

BACKGROUND : Clinical trials are critical to evaluate new therapies in non-Hodgkin lymphoma (NHL) and to enhance patient outcomes; however, accrual to these studies remain low. 1 Multiple patient- and healthcare provider (HCP)-related barriers contribute to the persistently low rates of trial participation. 2 Low enrollment in cancer clinical trials result in delays in the advancement of cancer research, as well as an escalation in the cost of developing and disseminating effective treatments. 2 HCPs play a critical role in advising, motivating, and recruiting patients to clinical trials. We designed a patient-provider tethered educational initiative in collaboration with the Leukemia and Lymphoma Society and BlackDoctors.org that examined real-world experiences and perceptions of clinical trials among HCPs, patients with NHL, and their caregivers. METHODS : Two educational activities were designed: The 1-hour patient/caregiver activity was broadcasted on CancerCoachLive.com in February 2023 and featured a multidisciplinary NHL expert panel of two hematologists/oncologists and a nurse practitioner. This program addressed the value of clinical trials, diverse representation, novel therapies under investigation, and real-world experiences from a patient panel. The complementary 1-hour HCP program was hosted on OMedLive.com in March 2023 and featured the same multidisciplinary NHL expert faculty panel and included pre-recorded patient interviews and an interactive live Q&amp;A. The online programs remain on-demand for one-year post-activity. Attitudes toward clinical trials were assessed in both activities (patient and HCP). Additionally, the HCP survey assessed barriers and challenges managing patients with NHL and intent to modify treatment plans post-program were also assessed. RESULTS : To date, 1,706 HCPs and 2,119 patients with NHL or their caregivers participated in this educational initiative. Of the HCPs, 78% were hematologists/oncologists, 15% practice at an academic medical center, 26% practice at a community hospital, and 65% manage an average of 15 patients with NHL per week. Of the patients/caregivers, 72% identified as White, 17% were Black/African American, 7% were Hispanic, 4% were Native Hawaiian/Pacific Islander, and 67% were ≥65 years old. Most of the participants (89%) in the patient/caregiver activity were ≥55 years old, 67% were &amp;gt;65 years. At the time of the assessment, 31% of patients were receiving watch and wait, 15% were in remission, 15% had recurrent/relapsed disease, and 12% reported having had newly diagnosed NHL. Most patients (93%) indicated that they have not participated in a clinical trial but were open to discussions with their HCPs. Patients and their caregivers expressed a high degree of interest in clinical trials. Specifically, 78% of respondents indicated that they would participate in a clinical trial if they were eligible. There were misalignments in patient-provider perceptions regarding the top patient concerns when considering participation in a clinical trial. Patients or their caregivers cited potential side effects (50%), associated costs of treatment (20%), and transportation/lack of time or resources (20%) as their top concerns related to clinical trial participation. HCPs cited fear of the unknown (34%), potential side effects (27%), and potential associated costs (15%) as their top concerns. Post-activity, 64% of patients or their caregivers indicated that they were confident in discussing clinical trials with their HCP. HCPs reported that the most common barrier to patient enrollment in clinical trials they were motivated to address at their institution post-activity were lack of clinical trials at their institution or geographic region (51%) and patient lack of interest (28%). CONCLUSIONS: These data from large groups of HCPs, patients, and caregivers provided valuable insights into patient, caregiver, and provider perceptions of clinical trials and strong willingness on the part of patients with NHL to participate in trials. Importantly, we found that targeted educational interventions can enable most patients and caregivers to feel confident in discussing clinical trials with their HCP and can motivate HCPs to increase clinical trial opportunities for diverse populations of patients with NHL. Unger JM, et al. Am Soc Clin Oncol Educ Book. 2016; 35:185-198.Ford JG et al. Cancer. 2008; 112:228-242.

Breaking barriers: Effective interventions amplifying minority participation in cancer clinical trials.

201 Background: Cancer-related mortality is disproportionately higher in marginalized populations, necessitating adequate representation in cancer clinical trials. Historically, this goal has been challenging, despite recognition of the importance for clinical practice. Moreover, minority recruitment has decreased in oncology clinical trials published from 2003-2016, indicating an urgent need for effective interventions for this issue. Methods: We conducted a systematic review of interventions focused on increasing minority recruitment/retention in cancer clinical trials between 2012-2023, or on improving attitudes of minority groups towards enrollment. We queried Embase and Scopus databases for articles/abstracts that focused on underrepresented ethnic minority enrollment in cancer clinical trials, in English language, were conducted in the US, Canada, Australia, New Zealand, or Western Europe, and were investigating effectiveness of interventions to improve minority enrollment in adult populations. Results: 261 unique articles/abstracts met our search criteria, with an additional 55 duplicates. 117 were removed for being irrelevant or too old, 31 for being reviews, 85 due to not containing an intervention, 5 for not reporting minority data, and 6 for not adequately comparing the strength of interventions. 17 met all inclusion criteria. Several interventions were identified, including targeted patient education (n=7), assigning patient navigators (n=6), community organization engagement (n=3), nested family/community approaches (n=2), and financial assistance (n=1). Targeted education involved video, audio, or interactive mediums. Most studies involved Black (n=12) and Hispanic (n=5) populations, with a smaller number focusing on Asian/Asian Pacific Islanders (n=2), Arabs (n=1), and Indian/South Asians (n=1). Geographically, these studies were notably concentrated in the American South (n=7). The Midwest and Mid-Atlantic regions contributed equally (n=3 each), and fewer studies were from the Northeast and West (n=2 each). Conclusions: Racial minorities continue to be underrepresented in cancer clinical trials, underscoring the need for concerted efforts to promote healthcare equity and enhance these trials’ generalizability. In our systematic review, targeted education, patient navigators, and active community engagement emerged as efficacious strategies, and were the most frequently utilized to bolster minority enrollment. Future studies should prioritize investigating and implementing these interventions, to ensure diverse, representative, and applicable clinical trial participation.

Assessing oncology patient interest in using telehealth for routine cancer care and clinical trials.

525 Background: Since the onset of COVID-19, oncology practices across the U.S. have integrated telemedicine (TM) and remote patient monitoring (RPM) into cancer care. However, the future role of telehealth in oncology remains unknown. We conducted a survey among a diverse group of oncology patients to assess their access to technology and interest in using TM/RPM as part of routine cancer care and clinical trials. Methods: Between March 27 and June 21, 2023, we administered in person surveys to oncology patients receiving cancer treatment at an academic cancer center in New York City. We collected respondent demographic and clinical data, as well as information about their access to technology and interest in using TM/RPM as part of cancer care. Results: There were 50 respondents with a mean age of 60 (SD 16). 62% identified as female, 22% were Hispanic of any race, 16% were non-Hispanic Black, and 48% were non-Hispanic White. 52% had a yearly income below $70,000 and 40% had less education than a bachelor’s degree. 34% had Medicare, 24% had Medicaid only, and 42% had commercial insurance. Regarding travel, 28% of respondents lived over an hour from the cancer center, and 39% paid &gt;$20 for travel each visit. The majority owned an electronic communication device (93%) and had internet access at home (98%). 80% had internet fast enough for video visits and 86% identified as comfortable using the internet. Prior to the survey, 66% of respondents had participated in a video visit and 59% had participated in a telephone visit with their oncologist. Of these patients, more than 95% were somewhat or very satisfied with their remote visit. If provided with internet, more than half of respondents were willing to participate in video visits (57%) and telephone visits (61%) as part of regular care. Convenience and eliminating travel were the most commonly cited reasons for preferring remote care. Regarding trial participation, 52% had previously enrolled in a cancer clinical trial and 67% reported openness to trial participation. If the risks and benefits of a trial were explained over the phone or in a video visit as opposed to in person, 73% of respondents reported they would be equally or more likely to enroll. If the risks and benefits had already been explained in person, 77% would be willing to sign consent electronically. A large majority (91%) would be equally or more likely to enroll in a clinical trial that reduced travel time by providing the option of remote visits. Similarly, 78% would be willing to use wearable technology and 80% would be willing to use a health app as part of a clinical trial. Conclusions: In this diverse and underprivileged group, patients have access to technology and are willing to use it for both routine cancer care and clinical trial enrollment and participation. In the future, oncology practices should incorporate remote technology into cancer care, including trials, to reduce travel time and enhance convenience.

Provider motivations and barriers to cancer clinical trial screening, referral, and operations: Findings from a survey.

Provider and institutional practices have been shown to have a large impact on cancer clinical trial enrollment. Understanding provider perspectives on screening for trial eligibility is necessary to improve enrollment. A questionnaire about incentives, barriers, process tools, and infrastructure related to opening trials and referring patients to onsite and offsite trials was administered to diverse stakeholders, including professional societies, advocacy organizations, and industry networks. Descriptive statistics were used to summarize findings. Overall, 693 responses were received, primarily from physicians (42.7%) and nurses (35.6%) employed at hospital health systems (43.7%) and academic centers (36.5%). Approximately half (49.2%) screened all patients for onsite clinical trials with screening typically done by manual chart review (81.9%). The greatest incentive reported for offering trials was providing the best treatment options for patients (67.7%). Contracting and paperwork (48.5%) were the greatest barriers to opening more onsite trials. Offsite referrals were rare. Screening for trial eligibility is a largely manual and ad hoc process, with screening and referral to offsite trials occurring infrequently. Administrative and infrastructure barriers commonly prevent sites from opening more onsite trials. These findings suggest that automated trial screening tools built into workflows that screen in a site-agnostic manner could result in more frequent trial eligibility screening, especially for offsite trials. With recent momentum, in part in response to the COVID-19 pandemic, to improve clinical trial efficiencies and broaden access and participant diversity, implementing tools to improve screening and referral processes is timely and essential. There are many factors that contribute to low adult enrollment in cancer clinical trials, but previous research has indicated that provider and institutional barriers are the largest contributors to low cancer clinical trial enrollment. In this survey, we sought to gain insight into cancer clinical trial enrollment practices from the perspective of health care providers such as physicians and nurses. We found that only approximately half of respondents indicated their institution systematically screens their patients for clinical trials and this process is manual and time consuming. Furthermore, we found that providers infrequently search for and refer patients to clinical trials at other sites. Creating better screening methods could improve enrollment in clinical trials.

Consensus recommendations for improving the cancer clinical trial matching environment.

Enrollment in cancer clinical trials cannot occur without first successfully identifying trials for which patients are a match based on their clinical characteristics. A lack of onsite matching trials has been identified as the single largest barrier preventing patients from participating in clinical trials. The site-agnostic cancer clinical trial matching environment is a mix of public and private tools and infrastructure that are not designed to work together to facilitate trial matching in an efficient manner. To identify policy and infrastructure solutions that could enable more effective and more frequent use of third-party site-agnostic matching, the American Cancer Society Cancer Action Network held a summit to examine challenges and propose consensus recommendations that could address those challenges. At this 2019 summit, stakeholders in this field examined these barriers and challenges and made a number of policy and infrastructure recommendations to improve the ability of this environment to work in a more coordinated and efficient manner.