Cancer Clinical Trial Enrollment Research Articles

The global burden of gynecologic oncology disease as reflected in clinical trials: An analysis of over 2,000 clinical trials (427)

Objectives: Worldwide, cervical cancer is the most common gynecologic cancer and a leading cause of death, yet there are relatively few randomized data relative to disease burden. Our objective was to analyze characteristics of randomized trials listed at ClinicalTrials. gov focused on cervical cancer. Methods: We included all studies listed at ClinicalTrials.gov registered between October 2007-March 2020 and manually reviewed for relevance to gynecologic oncology and cervical cancer. Patient and trial characteristics were analyzed. Results: A total of 223,690 trials were collected 2,152 of which were categorized as “gynecologic oncology” (0.9%). Of these, 350 (16.3%) trials investigated cervical cancer and enrolled a total of 332,309 patients, which accounted for 48.3% of all gynecologic oncology enrolled patients. Cervical cancer trials were more likely to enroll larger numbers of patients: 3.4% of cervical cancer trials (n=12) enrolled more than 1,000 patients compared to 2.0% for overall trials, 7.4% (n=26) versus 4.7% for 501-1,000 patients, and 28.9% (n=101) versus 25.5% (n=548) for 101-500 patients (p=0.03). Cervical cancer trials were more likely to draw patients only from low-income countries (27.7% vs 10.4%, p<0.001) and more likely to be single-center trials (58.3% vs 48.7%, p<0.001). Most cervical cancer trials (76.6%) focused on therapeutics (n=268) compared to 4.6% on screening (n=16), 8.0% imaging (n=28) and 7.1% supportive care (n=25). For therapeutics trials, those focusing on cervical cancer were less likely to investigate targeted therapeutics compared to overall gynecologic oncology trials, (28.3% of cervical trials compared to 57.3% overall) and chemotherapy (9.7% vs 17.7%), and more likely to focus on radiation (11.7% vs 3.6%), chemoradiation (11.7% vs 3.1%) and surgery (9.4% vs 6.0%, p<0.001). Cervical cancer trials were also less likely to have completed enrollment compared to gynecologic oncology trials overall (23.4% vs 31.4%, p<0.001). Conclusions: Cervical cancer clinical trial enrollment involves mostly large, single-institution studies from low-income countries that frequently have not achieved enrollment completion. Further attention is needed to develop pathways to ensure trial completion and balanced therapeutic foci for cervical cancer, especially in low- income countries. Objectives: Worldwide, cervical cancer is the most common gynecologic cancer and a leading cause of death, yet there are relatively few randomized data relative to disease burden. Our objective was to analyze characteristics of randomized trials listed at ClinicalTrials. gov focused on cervical cancer. Methods: We included all studies listed at ClinicalTrials.gov registered between October 2007-March 2020 and manually reviewed for relevance to gynecologic oncology and cervical cancer. Patient and trial characteristics were analyzed. Results: A total of 223,690 trials were collected 2,152 of which were categorized as “gynecologic oncology” (0.9%). Of these, 350 (16.3%) trials investigated cervical cancer and enrolled a total of 332,309 patients, which accounted for 48.3% of all gynecologic oncology enrolled patients. Cervical cancer trials were more likely to enroll larger numbers of patients: 3.4% of cervical cancer trials (n=12) enrolled more than 1,000 patients compared to 2.0% for overall trials, 7.4% (n=26) versus 4.7% for 501-1,000 patients, and 28.9% (n=101) versus 25.5% (n=548) for 101-500 patients (p=0.03). Cervical cancer trials were more likely to draw patients only from low-income countries (27.7% vs 10.4%, p<0.001) and more likely to be single-center trials (58.3% vs 48.7%, p<0.001). Most cervical cancer trials (76.6%) focused on therapeutics (n=268) compared to 4.6% on screening (n=16), 8.0% imaging (n=28) and 7.1% supportive care (n=25). For therapeutics trials, those focusing on cervical cancer were less likely to investigate targeted therapeutics compared to overall gynecologic oncology trials, (28.3% of cervical trials compared to 57.3% overall) and chemotherapy (9.7% vs 17.7%), and more likely to focus on radiation (11.7% vs 3.6%), chemoradiation (11.7% vs 3.1%) and surgery (9.4% vs 6.0%, p<0.001). Cervical cancer trials were also less likely to have completed enrollment compared to gynecologic oncology trials overall (23.4% vs 31.4%, p<0.001). Conclusions: Cervical cancer clinical trial enrollment involves mostly large, single-institution studies from low-income countries that frequently have not achieved enrollment completion. Further attention is needed to develop pathways to ensure trial completion and balanced therapeutic foci for cervical cancer, especially in low- income countries.

Barriers and facilitators to genomic testing uptake and cancer clinical trial enrollment in historically underrepresented patient populations - Clinician and research staff perceptions

Barriers and facilitators to genomic testing uptake and cancer clinical trial enrollment in historically underrepresented patient populations - Clinician and research staff perceptions

Barriers and facilitators to cancer clinical trial enrollment and participation among rural populations: a scoping review protocol.

The objective of this scoping review is to identify barriers and facilitators related to cancer clinical trial enrollment and participation among rural populations. Advancing the effectiveness of cancer treatment and increasing early detection of cancer relies on enrollment and participation of individuals in cancer clinical trials. Lack of enrollment and participation in trials is a concern, and there is evidence that individuals living in rural areas are unlikely to participate in such trials. Information on barriers to, and facilitators of, enrollment and participation in cancer clinical trials is needed for the development of evidence-based interventions to increase the enrollment and participation of rural populations. The review will consider studies on adults aged 18 years or older living in rural areas. Studies that report on barriers and facilitators to enrollment and participation in cancer clinical trials, including both cancer therapeutic and cancer early detection trials, will be included in the review. The review will consider quantitative, qualitative, and text and opinion papers for inclusion. The search strategy will aim to locate published primary studies, reviews, and opinion papers, the latter including those by professional oncology organizations. The databases to be searched include MEDLINE, CINAHL, Embase, Web of Science, and Cochrane Library. Gray literature databases will also be searched. Two independent reviewers will retrieve full-text studies and extract data. The results will be presented in diagrammatic format with a narrative summary.

AACR Cancer Disparities Progress Report 2022.

AACR Cancer Disparities Progress Report 2022.

A Scoping Review of Strategies to Increase Black Enrollment and Retention in Cancer Clinical Trials.

To address health disparities faced by Black patients with cancer, it is critical that researchers conducting cancer clinical trials (CCTs) equitably recruit and retain Black participants, develop strategies toward this aim, and document associated outcomes. This narrative scoping literature review, as part of a larger study, aimed to identify, describe, and categorize strategies and interventions intended to improve the recruitment and retention of Black participants with breast, lung, prostate, colorectal, or multiple myeloma cancer into CCTs. We conducted comprehensive searches in PubMed, Embase, Cochrane Library, PsycInfo, CINAHL, Scopus, and Web of Science with three main concepts: Black persons, neoplasms, and clinical trial recruitment. The search resulted in 1,506 articles, of which 15 met inclusion criteria. Five main categories of recruitment and retention strategies and interventions were identified based on their specific population focus and type of approach: (1) participant identification, (2) provider awareness/resources, (3) focused research staff interventions, (4) patient and community-focused awareness strategies, and (5) participant-directed resources. Thirteen studies had recruitment acceptance rates of over 30%. Eight studies with acceptance rates of ≥ 50% reported implementing ≥ 5 strategies, with an average use of seven strategies across multiple categories. Five studies with acceptance rates ≥ 50% implemented strategies in ≥ 3 categories. Four studies reported retention rates ≥ 74%. Three studies with reported retention rates ≥ 74% used strategies in ≥ 3 categories, and all included strategies aimed at meeting participant needs beyond the study. Our results show that many efforts that aim to increase the recruitment and retention of Black participants into CCTs have great potential, but the most promising strategies use a multiprong approach.

PACCT: An intervention to improve communication quality and clinical trial invitations for Black and White men with prostate cancer.

e24137 Background: Cancer clinical trial enrollment rates are low, with Black individuals especially underrepresented. We tested Partnering Around Cancer Clinical Trials (PACCT), a multi-level intervention designed to improve patient-physician communication and increase trial invitations among Black and White men with prostate cancer. This study reports only on PACCT Phase 1, the patient-focused intervention, because data collection for PACCT Phase 2, the physician-focused intervention, was halted by the COVID-19 pandemic. Methods: Black and White men with prostate cancer and their physicians were invited to participate. Patients were tracked &lt;two years for trial eligibility, with eligible patients randomized to usual care or intervention. Intervention patients received a brochure that included text promoting patient-physician partnerships and a trial-focused Question Prompt List to encourage them to participate actively in clinic visits, such as by asking questions or stating concerns. Patient-physician visits with eligible patients were video-recorded. After the visits, communication (i.e., patient active participation and physician patient-centered communication) was assessed via patient self-report and observer ratings of video-recordings. Medical chart abstractions determined trial invitations. Univariable logistic mixed-effects models nesting patients within physicians tested intervention effects by race on communication and trial invitation. Results: Among 199 participants (91 Black; 108 White), 22% (n = 44; 20 Black, 24 White) became eligible for a trial and received the intervention (n = 19) or usual care (n = 25). Regarding communication, Black intervention patients reported participating more actively than those in usual care (difference = 0.41, 95% CI -0.27-1.08), while White intervention patients reported participating less actively than those in usual care (difference = -0.34, 95% CI -0.72-0.05). No differences in observer ratings of active participation or self-report or observer ratings of physician communication were found. Regarding trial invitations, findings were nonsignificant, but showed more intervention patients (74%) than usual care patients (60%) received invitations (logOR = 1.97, 95% CI -0.30 to 4.24), with Black intervention patients having higher odds of receiving invitations (80%) than White intervention patients (67%) (logOR = 3.84, 95% CI -0.92 to 8.59 vs. logOR = -0.14, 95% CI -4.61 to 4.50). Conclusions: Few patients (22%, n = 44) became eligible for a trial during PACCT Phase 1. Despite this small sample, the PACCT intervention showed promise in increasing active participation among Black patients and in increasing clinical trial invitations for both Black and White patients. Future research should test this intervention in a larger sample and in combination with the physician-focused intervention. Clinical trial information: NCT02906241.

A mixed-methods study of minority patients treated on a cancer clinical trial at a tertiary referral center.

e18543 Background: Representation of minority patients (pts) in cancer clinical trials (CCTs) is low and contributes to health disparities. Our study sought to understand the beliefs and motivations of minority patients and to identify barriers and facilitators of CCT enrollment. Methods: 270 minority pts treated on CCT were identified from the medical record from 2018-2021. Of the 138 of pts alive, 13 (9.4%) consented. Semi-structured qualitative interviews were conducted exploring motivations, barriers, and facilitators to CCT participation. Surveys collected demographics and explored beliefs towards cancer and factors that influenced participation. Results: Of the 13 participants, 9 were female (69%), 4 Hispanic (30%), 3 Black (23%), 3 multiple races (23%), 2 Asian (15%), 2 Native American (15%), and 1 Native Hawaiian (8%). Two pts had a high school education (15%), 7 ≥ 4-year college (54%), 4 ≥ 2-year college (30%). Eight pts were married, 3 divorced, 1 widowed, and 1 single. Employment status was: employed (4 pts, 30%), unemployed (1 pt, 8%), disabled (5 pts, 38%), retired (3 pts, 23%). All pts were insured. Median household was 3 people (range 1 to &gt; 5); 3 pts had dependents. 9 pts had their own vehicle; 4 used public or subsidized transport. 2 pts had trouble finding transportation. Income was: 3 pts &lt; 25K, 4 pts 25-35K, 1 pts 35-50 K, 1 pts 50-75K, and 4 pts &gt; 75K. 4 pts received emotional support from religion. All pts had heard of CCTs and 6 (46%) had known other CT participants. Direct communication from healthcare provider was the most common way of hearing about CCT. 9 pts (69%) had trust or strong trust in experimental therapy/CCT; 4 pts (30%) were neutral. 8 pts (61%) believed standard therapy was needed to cure cancer. 5 pts (38%) believed God would decide if they die from cancer. 7 pts (54%) believed that worry makes cancer worse. Key themes about patients’ motivation to participate: chance for cure, staying positive, giving back to others, having representation in research, and advancing science. Key themes about facilitators to participation: supportive family, cost coverage for treatment, and limited treatment options. Key themes on participation: minimizing logistical barriers, decentralizing CCTs, increasing awareness via patient narratives, diversifying research staff, minimizing cost, and being clear on purpose and benefit of CCT. Factors from survey that influenced participation are summarized in Table. Conclusions: Understanding minority pts experience through in-depth interviews is valuable and may help with recruitment.[Table: see text]

A mixed-methods study of healthcare provider perspectives on the barriers to enrollment of minority patients on cancer clinical trials.

e18544 Background: Underrepresented minority (URM) patients continue to make up a small percentage of patients treated on cancer clinical trials (CCTs), thus perpetuating health care disparities. Research indicates that engagement of healthcare staff is critical for successful recruitment. Our study sought to better define barriers to minority recruitment to CCT from the research staff perspective. Methods: Semi-structured qualitative interviews were conducted of key stakeholders for CCT enrollment, including clinical research coordinators (CRCs), principal investigators (PIs), and treating clinicians. Questions for the healthcare team explored their experiences caring for URM patients with specific inquiry into the barriers of enrollment/retention and the processes or resources required to better meet patient needs. Results: All hematology and oncology staff at Mayo Clinic Cancer Center were invited to participate via email. Of the 28 who consented, 13 were male (46%), 15 female (54%), and 21% non-white (3 Asian, 2 Hispanic, 1 Black). Of the 19 PIs, 9 were Professors (47%), 5 Associate professors (26%), and 5 Assistant professors (26%). The additional 9 interviewees were CRCs. Select themes with representative quotes and proposed actions can be seen in Table. Conclusions: Recommendations for CCT accrual include accelerating efforts to address workforce diversity gaps, engaging in community outreach, optimization of CCT participation through collaborative care, incentivizing trial participation, and creating flexibility in eligibility criteria.[Table: see text]

Evaluating patient risk factors associated with low rates of breast cancer clinical trial accrual.

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

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

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

HSR22-126: Key Factors Associated With Breast Cancer Clinical Trial Enrollment in Underrepresented Minority Groups

HSR22-126: Key Factors Associated With Breast Cancer Clinical Trial Enrollment in Underrepresented Minority Groups

Shared barriers and facilitators to enrollment of adolescents and young adults on cancer clinical trials

Adolescent and young adult (AYA) enrollment in cancer clinical trials (CCT) is suboptimal. Few studies have explored site level barriers and facilitators to AYA enrollment on CCTs and the efficacy of interventions to enhance enrollment. A cross sectional survey was developed by the COG AYA Oncology Discipline Committee Responsible Investigator (RI) Network to identify perceived barriers and facilitators to enrollment, as well as opportunities to improve enrollment. Associations of barriers and facilitators to enrollment with program demographics were assessed. The survey was sent to all AYA RI Network members (n = 143) and quantitative and thematic analyses were conducted. The overall response rate was 42% (n = 60/143). Participants represented diverse institutions based on size, presence or absence of dedicated AYA programs, and proximity and relationship between pediatric and medical oncology practices within the institution. The most frequently cited barriers to enrolling AYAs in CCTs were administrative logistical issues (45%), disparate enrollment practices (42%) and communication issues (27%) between pediatric and medical oncology and perceived limited trial availability (27%). The most frequently reported facilitators to enrollment included having strong communication between pediatric and medical oncology (48%), having a supportive research infrastructure (35%) and the presence of AYA champions (33%). Many barriers and facilitators were similar across institutions and AYA program types. Shared barriers and facilitators to AYA CCT enrollment exist across the landscape of cancer care settings. Interventions aimed at increasing coordination between pediatric and medical oncology clinical trials offices and providers have high potential to improve site-level AYA enrollment.

Comparing Barriers and Facilitators to Adolescent and Young Adult Clinical Trial Enrollment Across High- and Low-Enrolling Community-Based Clinics.

Adolescent and young adult (AYA) patients with cancer are underrepresented on cancer clinical trials (CCTs), and most AYAs are treated in the community setting. Past research has focused on individual academic institutions, but factors impacting enrollment vary across institutions. Therefore, we examined the patterns of barriers and facilitators between high- and low-AYA enrolling community-based clinics to identify targets for intervention. We conducted 34 semi-structured interviews with stakeholders employed used at National Cancer Institute Community Oncology Research Program (NCORP) affiliate sites ("clinics"). Stakeholders (eg, clinical research associates, patient advocates) were recruited from high- and low-AYA enrolling clinics. We conducted a content analysis and calculated the percentage of stakeholders from each clinic type that reported the barrier or facilitator. A 10% gap between high- and low-enrollers was considered the threshold for differences. Both high- and low-enrollers highlighted insufficient resources as a barrier and the presence of a patient eligibility screening process as a facilitator to AYA enrollment. High-enrolling clinics reported physician gatekeeping as a barrier and the improvement of departmental collaboration as a facilitator. Low-enrollers reported AYAs' uncertainty regarding the CCT process as a barrier and the need for increased physician endorsement of CCTs as a facilitator. High-enrolling clinics reported more barriers downstream in the enrollment process, such as physician gatekeeping. In contrast, low-enrolling clinics struggled with the earlier steps in the CCT enrollment process, such as identifying eligible trials. These findings highlight the need for multi-level, tailored interventions rather than a "one-size-fits-all" approach to improve AYA enrollment in the community setting.

Association between Prior Malignancy Exclusion Criteria and Age Disparities in Cancer Clinical Trials.

Simple SummaryRecent studies have shown that the incidence of age disparities in cancer clinical trials may be increasing over time. Excluding patients with prior malignancies is one such eligibility criterion through which elderly may inadvertently be excluded from clinical trial participation. While strict enrollment criteria may improve internal validity of studies, they can also negatively impact generalizability of results. As such, we sought to characterize the incidence of prior malignancy exclusion criteria in phase III cancer clinical trials and assess if this eligibility criterion may directly contribute to age disparities. These data support efforts to modernize eligibility criteria and inform best practices regarding acceptable versus unacceptable exclusionary timeframes for prior malignancy exclusion criteria. Prior malignancy exclusion criteria (PMEC) are often utilized in cancer clinical trials; however, the incidence of PMEC and the association of PMEC with trial participant age disparities remain poorly understood. This study aimed to identify age disparities in oncologic randomized clinical trials as a result of PMEC. Using a comprehensive collection of modern phase III cancer clinical trials obtained via ClinicalTrials.gov, we assessed the incidence and covariates associated with trials excluding patients with prior cancers within 5+ years from registration (PMEC-5). Using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database, we further sought to determine the correlation between PMEC-5 and age disparities. PMEC-5 were used in 41% of all trials, with higher PMEC-5 utilization among industry-supported trials as well as trials evaluating a targeted therapy. Comparing trial patient median ages with population-matched median ages by disease site and time-period, we assessed the association between PMEC-5 and age disparities among trial participants. PMEC-5 were independently associated with heightened age disparities, which further worsened with longer exclusionary timeframes. Together, PMEC likely contribute to age disparities, suggesting that eligibility criteria modernization through narrower PMEC timeframes may work toward reducing such disparities in cancer clinical trial enrollment.

Abstract PR-09: Eligibility criteria perpetuate disparities in enrollment and participation in pancreatic cancer clinical trials

Abstract Introduction: Clinical trials determine efficacy and safety of cancer therapeutics and set the standard of care. Inequitable representation of participants leaves gaps in our knowledge, limits opportunities to investigational therapeutics and subsequently perpetuates disparities in survivorship. Clinical trial eligibility criteria have been postulated to differentially impact certain racial/ethnic groups which have higher prevalence of infectious and chronic diseases. We aimed to determine the impact of eligibility criteria on disparities in pancreatic cancer clinical trial candidacy. Methods: Common eligibility criteria for Phase 2 and 3 pancreatic cancer trials listed in clinicaltrials.gov were compiled for simulation of a clinical trial screening process. Patients with pancreatic ductal adenocarcinoma who sought care at VCU Massey Cancer Center (Richmond, VA) from 2010-2019 were included. Clinical variables pertaining to eligibility criteria were obtained from billing codes and discrete values in the medical record. Inclusion/exclusion criteria were applied to determine overall eligibility and for individual criterion. Chi-squared tests were utilized to identify statistically significant differences in patient eligibility between racial groups. Results: A total of 676 patients with pancreatic cancer were identified, with Black (42%) and White (52%) patients comprising the majority of the patient population. Black patients were significantly more likely than White patients to be deemed ineligible based on Creatinine (6.08% vs 2.27%, p = 0.036), HIV (3.136% vs 0.286%, p = 0.01), Hepatitis B (1.742% vs 0%, p = 0.043), and Hepatitis C (9.06 vs 3.43%, p = 0.005). Black patients were also more likely to be ineligible based on Albumin (12.45% vs 7.47%, p = 0.076), history of coronary stenting in the past 6 months (1.39% vs 0%, p = 0.087), and uncontrolled diabetes (8.96% vs 6.07%, p = 0.244), although differences in these criteria did not achieve statistical significance at 5% level. History of prior cancer treatment was the only variable that excluded less Black patients than White patients (9.06% vs 14.0%, p = 0.072) and was attributable to more White patients initiating neoadjuvant chemotherapy for their pancreatic cancer prior to seeking care at VCU. After applying all criteria, Black patients were more likely to be ineligible for participation compared to White patients (42.0% vs 33.3%, p = 0.039). Conclusion: Standard pancreatic cancer clinical trial eligibility criteria differentially exclude Black patients from participating in clinical trials. These criteria perpetuate racial disparities, limit generalizability to real world clinical scenarios, and are often not medically justifiable. Alternative eligibility criteria can improve representation of diverse participants, provide more equitable access to investigational therapeutics and reduce disparities in survivorship, without compromising patient safety or study results. Citation Format: Andrea N. Riner, Selamawit Girma, Nevena Skoro, Tamas S. Gal, Kelly M. Herremans, Nitai Mukhopadhyay, Vignesh Vudatha, Shreya Raman, Thomas George, Jose G. Trevino. Eligibility criteria perpetuate disparities in enrollment and participation in pancreatic cancer clinical trials [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PR-09.

A qualitative study of barriers and facilitators to adolescents and young adults' participation in cancer clinical trials: Oncologist and patient perspectives.

Despite efforts to increase participation of adolescents and young adults (AYAs; 15-39years) in cancer clinical trials (CTs), enrollment remains very low. Even when provided access to CTs, AYAs are less likely to participate than children and older adults. A better understanding of oncologist- and AYA survivor-reported barriers, facilitators, and potential areas for CT enrollment improvement is needed. From December 2019 to August 2020, we conducted 43 semi-structured interviews with oncologists (n=17) and AYA cancer survivors (n=26) who were offered and/or participated in CTs at cancer centers in California and Utah. Thematic analyses were used to interpret the findings. Oncologists identified a lack of available CTs, strict eligibility criteria, lack of awareness of open CTs, and poor communication between pediatric and adult oncologists as major barriers to enrollment. AYA cancer survivors identified financial and psychosocial barriers, and a poor understanding of what a CT means and its potential benefits as barriers to enrollment. Areas for improvement identified by oncologists and AYAs include educational, financial, and psychosocial support to AYAs. Oncologists also emphasized the need to increase CT availability, improve awareness of open CTs, and better communication between both pediatric and adult oncologists and oncologists and AYAs. For AYAs with cancer, a lack of CT eligibility and physician awareness of open CTs likely factor into their lower CT enrollment. Potential strategies to improve AYA enrollment in CTs require comprehensive collaboration between pediatric and adult institutions, as well as educational, psychosocial, and financial support to AYAs.

Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers

IntroductionEquitable and diverse clinical trials participation is essential for practice-changing results to be applicable to all patients. However, patients who identify as minorities, who live in rural areas, and who have low income are typically underrepresented in clinical trials. Increasing clinical trial participation in general and among underrepresented patients in particular is a goal of The Leukemia & Lymphoma Society's (LLS) Clinical Trial Support Center (CTSC), a clinical trial nurse navigation service for patients with blood cancers and their oncologists.The Veterans Health Administration (VA) is a national network of health care facilities. Approximately 3% of cancers in the United States are diagnosed in the VA. The prevalence of certain blood cancers is higher in the VA, in part due to military exposures. Veterans who receive care in the VA are more likely to have lower income, live in rural areas, and have comorbidities than patients who receive care in the private sector. Clinical trial participation among Veterans may be hampered by VA-specific factors (e.g. relatively fewer clinical trial options in the VA, lack of awareness that Veterans may be referred to participate in clinical trials outside of the VA) and patient-specific factors (e.g. income, rurality, comorbidities, and minority status). This study aimed to characterize and overcome barriers to Veteran enrollment in blood cancer clinical trials.MethodsThe LLS CTSC performs clinical trial searches using a database with information from clinicaltrials.gov and other proprietary data. To assess the impact of geography and rurality on the availability of clinical trials, we performed simulated searches for clinical trials in proximity of 13 VA facilities (6 rural, 7 urban), six blood cancers (AML, CLL, DLBCL, FL, MDS, MM), and two disease statuses (new diagnosis, relapsed/refractory). To further evaluate barriers to CTSC referral and clinical trial enrollment among Veterans who receive care in the VA, we collected data about referral patterns of VA hematologist-oncologists and Veterans' treatment choices at four VA facilities between September 2020 through May 2021.ResultsWhen evaluating both 100- and 200-mile radii from the VA facilities in simulated searches, there were significantly more clinical trials available for Veterans who receive care in urban compared to rural areas and on the East or West Coast compared to the Midwest, in aggregate (all cancers) and by disease type or status (p unadj < 0.0001).Forty-eight Veterans with blood cancers at the Durham NC, Salem VA, Sioux Falls SD, and Clarksburg WV VA facilities had consideration of clinical trials as a treatment option by oncology providers over a nine-month period. All Veterans were male, with 33 White/15 African-American, 47 non-Hispanic/1 Hispanic, age 41-93 years (median 71), living 0.2-186 miles from their VA facility (median 33.1), with diverse diseases and stages represented.Of the 48 patients, 14 patients were not asked if they wanted clinical trials information; reasons were need for immediate therapy, co-morbidities, or patient circumstances. Of 34 patients who were asked if they wanted clinical trials information, 14 did not agree to a referral to the CTSC; reasons were preference for immediate therapy, wanting care in the VA, wanting standard therapy, and lack of transportation. Of 20 referred Veterans, two enrolled in clinical trials outside the VA (for CLL and PMF), with investigational therapy provided by the study sponsors.ConclusionsUsing data from simulated and actual patient referrals to the LLS CTSC, we identified patient, provider, and location specific barriers for Veteran referral and enrollment in blood cancer clinical trials. When offered information about clinical trials, the majority of patients agreed to an LLS CTSC referral, suggesting that patients are generally willing to receive education and information about trial participation if given the opportunity. The LLS CTSC nurse navigators can overcome barriers to enrollment by providing education and identifying potential clinical trials within a desired geographic area. In addition to resources provided by the LLS CTSC, opening additional clinical trials in rural areas and within the VA system could help increase Veteran participation in clinical trials for blood cancers. DisclosuresRodgers: MJH Lifesciences: Consultancy. Weiss: AbbVie Inc.: Research Funding; Amgen Inc.: Research Funding; AstraZeneca Pharmaceuticals: Research Funding; Bristol Myers Squibb: Research Funding.

Access Denied: Inequities in Clinical Trial Enrollment for Pancreatic Cancer.

The influence of social determinants of health (SDH) on participation in clinical trials for pancreatic cancer is not well understood. In this study, we describe trends and identify disparities in pancreatic cancer clinical trial enrollment. This is a retrospective study of stage I-IV pancreatic cancer patients in the 2004-2016 National Cancer Database. Cohort was stratified into those enrolled in clinical trials during first course of treatment versus not enrolled. Bivariate analysis and logistic regression were used to understand the relationship between SDH and clinical trial participation. A total of 1127 patients (0.4%) enrolled in clinical trials versus 301,340 (99.6%) did not enroll. Enrollment increased over the study period (p < 0.001), but not for Black patients or patients on Medicaid. The majority enrolled had metastatic disease (65.8%). On multivariate analysis, in addition to year of diagnosis (p < 0.001), stage (p < 0.001), and Charlson score (p < 0.001), increasing age [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.96-0.97], non-white race (OR 0.54, CI 0.44-0.66), living in the South (OR 0.42, CI 0.35-0.51), and Medicaid, lack of insurance, or unknown insurance (0.41, CI 0.31-0.53) were predictors of lack of participation. Conversely, treatment at an academic center (OR 6.36, CI 5.4-7.4) and higher neighborhood education predicted enrollment (OR 2.0, CI 1.55-2.67 for < 7% with no high school degree versus > 21%). Age, race, insurance, and geography are barriers to clinical trial enrollment for pancreatic cancer patients. While overall enrollment increased, Black patients and patients on Medicaid remain underrepresented. After adjusting for cancer-specific factors, SDH are still associated with clinical trial enrollment, suggesting need for targeted interventions.

ASO Author Reflections: Seizing the Momentum to Diversify Cancer Clinical Trial Enrollment.

ASO Author Reflections: Seizing the Momentum to Diversify Cancer Clinical Trial Enrollment.

The role of clinical research nurses in minority recruitment to cancer clinical trials

Clinical trials (CTs) are the established research mechanism designed to examine how new medical therapies are tested for safety and effectiveness. Specifically, non-Hispanic White patients still account for most CT participants and Black patient participation has declined over the past decade. Clinical Research Nurses (CRNs) whose scope of practice includes the recruitment of participants for CTs, have the potential to significantly increase minority patients participation in cancer clinical trials (CCTs). The aim of this phenomenological study was to describe adult oncology CRNs' lived experiences of recruiting minority cancer patients to participate in CTs. A total of 19 nurses participated in semi-structured one-to-one interviews and data analysis was based on Colaizzi's method. The role of CRNs was described as advocates who coordinate care, establish trust, and provide education for CT patients within physician-driven recruitment structures. The CRN's role was also described as self-taught or learn on the go with no formalized recruitment training and lack of robust cultural training. To achieve diverse patient enrollment in CCTs, CRNs and study staff need to receive training on culturally competent clinical research care and the diversity of CRNs and study teams must be increased. Further, meaningful federal and hospital policy change must occur so that minority patients have equitable access to novel cancer therapies and the role of the CRN is delineated from other healthcare staff to optimize research patient care.