Clinical Trial Enrollment Rates Research Articles

Geriatric enrollment patterns in clinical trials at a National Cancer Institute.

e13762 Background: Despite the majority of new cancer diagnoses occurring within the geriatric population, there is a disproportionate rate of clinical trial enrollment within this population. Previous data has estimated enrollment rate to be 18.9% in treatment trials among all adult cancer patients at designated National Cancer Institute Cancer Centers. The objective of this study is to assess geriatric cancer patient clinical trial enrollment rates in a single National Cancer Institute and highlight inequities within cancer care delivery. Methods: We performed a retrospective review of the electronic health record and included patients with cancer ≥ 65 years of age who died at our institution between January 2020 and July 2022. We examined the relationship between cancer type, patient race/ethnic identity, and age and analyzed enrollment in clinical trials. Analyses were conducted using descriptive statistics. Results: Of 117 decedent records analyzed, 11 (9%) were enrolled in treatment clinical trials of which 5 (4.3%) identified as White, 4 (3.4%) Other, and 2 (1.7%) Hispanic. Among the 117 geriatric patient records reviewed, there were 21 Black patients (17.9%) of which 0 (0%) Black patients were enrolled in clinical trials. In comparing enrollment by malignancy type, 5 patients had a hematologic malignancy (leukemia, lymphoma, or multiple myeloma), 3 patients had a genitourinary malignancy, 1 patient had a pancreatic malignancy, 1 patient had an endometrial malignancy, and 1 patient had a breast malignancy. Among all patients analyzed, 37 patients (31.6%) had a hematologic malignancy and 80 patients (68.4%) had a solid tumor malignancy. The average age of enrolled patients was 73, consistent with the average age of all patients analyzed (73.78). Conclusions: Geriatric patients with cancer are disproportionately underrepresented in treatment clinical trials. The inequity is exacerbated when analyzing enrollment among minoritized patients. There was a greater proportion of clinical trial enrollment in patients with hematologic malignancies than solid tumor malignancies, however analysis in larger population samples is necessary. Additional research to identify barriers to clinical trials and methods of increasing geriatric enrollment, including the use of geriatric specific performance scales, is necessary to ensure equitable access and representation in clinical trials. While these results may be skewed in the setting of the COVID-19 pandemic and selection of a decedent population, further research into geriatric accessibility in clinical trials is paramount.

NGS panels' capture of biomarkers associated with targeted therapies in clinical trials.

e13508 Background: ASCO and NCCN guidelines strongly encourage participation in clinical trials though participation rates remain low. Although up to 60% of trials require biomarker information as a prerequisite to participation, guidelines are silent on biomarker testing to assess eligibility. To help inform policy development, we analyzed commercially available NGS panels to assess the capture rate of the specific gene variants required for targeted therapies in clinical trials. Methods: Publicly available gene variant information on 12 high volume NGS tissue and plasma commercial assays representative of panel size was accessed. The JAX-CKB database was queried to identify genomic prerequisites in active phase I-III clinical trials; mRNA and protein expression biomarkers were excluded. We used unpaired t-testing to compare the ability of large versus small panels to detect variants required for targeted treatments. (Somatic gene variant annotations and related content have been powered by The Jackson Laboratory Clinical Knowledgebase (JAX-CKBTM)). Results: Overall, 185 genes were linked to eligibility for targeted therapies in clinical trials (Table). Large panel assays (>80 genes) had a higher average capture rate compared to smaller panels, (84% vs. 46%, p value < 0.000002). Similarly, capture rates in select cancers were higher in larger panels: lung (85% vs 59%), breast (92% vs 54%), prostate (86% vs 34%), pancreatic (84% vs 54%), colorectal (88% vs 52%). All results were statistically significant (p < 0.05). Smaller panels were more likely to exclude large genes (e.g. BRCA), genome-wide signatures (e.g. TMB), fusions, and copy number variants. Conclusions: NGS-based panels with more than 80 genes had higher capture rates for biomarkers required for clinical trials of targeted therapies. Clinicians searching for all relevant treatment options for patients should include large genomic sequencing panels to maximize identification of potential clinical trial eligibility. Professional societies and policy makers interested in enhancing clinical trial enrollment rates should consider the panel size-related variability in capture rates of genetic variants when developing recommendations. [Table: see text]

Influence of socioeconomic status on clinical outcomes of diffuse midline glioma and diffuse intrinsic pontine glioma.

Given the lack of a definitive treatment and the poor prognosis of patients with diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG), socioeconomic status (SES) may affect treatment access and therefore survival. Therefore, this study aimed to examine the relationship between SES and treatment modalities, progression-free survival (PFS), and overall survival (OS) in children with DMG/DIPG. A retrospective, single-institution review was conducted of medical records of patients ≤ 18 years of age who had DMG or DIPG that was diagnosed between 2000 and 2022. Patient demographics, surgical interventions, chemotherapy, radiation therapy, clinical trial enrollment, and medical care-related travel were extracted. SES variables (education and mean income) for associated patient census tracts were collected and stratified. Statistical analysis using unpaired t-tests, chi-square analysis, and log-rank tests was conducted. Of the 96 patients who met the inclusion criteria, the majority were female (59%) and non-Hispanic White (57%). The median PFS, median OS, and time from diagnosis to treatment did not differ between races/ethnicities or sex. Ninety-one of 96 patients had census tract data available. Patients from higher-income census tracts (> 50% of families with annual household income greater than $50,000) had a longer median OS (480 vs 235 days, p < 0.001) and traveled significantly longer distances for medical care (1550 vs 1114 miles, p = 0.048) than families from lower-income census tracts. Patients from the highest education quartile traveled significantly farther for treatment than the lowest education quartile (mean 2964 vs 478 miles, p = 0.047). Patients who received both oral and intravenous chemotherapy were more likely to be from higher-income census tracts than those who received intravenous or no chemotherapy. Duration of PFS, rates of clinical trial enrollment, biopsy rates, H3K27 mutation status, ventriculoperitoneal shunt placement rates, and radiotherapy rates were not associated with SES variables. Patients from families from higher-income census tracts experienced longer OS and traveled farther for treatment. Patients from families from higher-education-level census tracts traveled more often for treatment. The authors' findings suggest that SES influences DMG and DIPG OS. More studies should be done to understand the role of SES in the outcomes of children with DMG/DIPG.

Abstract PD1-10: Impact of Race on Clinical, Socioeconomic, and Genomic Characteristics, Clinical Trial Participation, and Receipt of Genotype-matched Therapy Among Patients with Metastatic Breast Cancer

Abstract Background: Clinical outcomes in breast cancer differ across racial and ethnic populations. We have previously demonstrated that receipt of genotype-matched therapy targeted to an actionable mutation may potentially improve patient outcomes (Vidula, CCR, 2021). We evaluated the impact of race on clinical, socioeconomic, and genomic characteristics, clinical trial participation, and receipt of genotype-matched therapy among patients with metastatic breast cancer (MBC). Methods: We conducted a retrospective study of patients with MBC at an academic institution who underwent cell-free DNA testing (cfDNA, Guardant360, 74 gene panel) as part of routine clinical care from 11/29/2016-11/2/2020. Patient demographics (including self-reported race and ethnicity) and clinical trial enrollment (at same institution) were determined by retrospective data collection. Mutations identified in cfDNA were characterized as actionable based on the variant interpretation performed by Guardant360 using vetted genomic databases, and receipt of genotype-matched therapy targeted to an actionable mutation was determined as previously described (Vidula, CCR, 2021). Pearson’s chi-squared and Wilcoxon rank-sum tests were used to compare categorical and continuous variables between groups, with p&amp;lt; 0.05 indicating statistical significance. Results: Four hundred and twenty-five patients with MBC and cfDNA results were identified, of which 369 were White (87%), 27 Black (6.4%), 15 Hispanic (3.5%), and 14 Asian (3.3%). There were no significant differences in median age at MBC diagnosis (p=0.064), disease subtype distribution (p=0.74), proportions of de-novo/recurrent MBC (p=0.95), presence of visceral metastases (p=0.84), Charleston comorbidity index (p=0.93), menopausal status (p=0.3), and level of education (p=0.44) across racial groups. Higher proportions of non-primary English speakers were seen in Hispanic (80%) and Asian (29%) races (p&amp;lt; 0.001). Median distance traveled to the institution also varied based on race, with White patients traveling further (White: 39.1 miles, Black: 21.8 miles, Hispanic 9.4 miles, Asian 9.1 miles, p&amp;lt; 0.001). In addition, type of insurance varied based on race, with White patients having the highest rates of commercial insurance and Medicare, Black patients having the highest rate of state-supported insurance, and Asian patients having the highest uninsured rates (p&amp;lt; 0.001). Clinical trial enrollment rates did not significantly differ by race (White: 44%, Black: 37%, Hispanic: 47%, and Asian 21%, p=0.34), but patients without insurance were significantly less likely to be enrolled on a trial than those with commercial insurance (p=0.03). The proportion of patients with ≥1 actionable mutation in cfDNA did not vary significantly by race (White: 78%, Black: 56%, Hispanic: 73%, Asian 86%, p=0.18) and the median number of actionable mutations found in cfDNA was similar across races (p=0.31). However, receipt of genotype-matched therapy targeted to an actionable mutation varied by race, with the highest rates of matched therapy in White patients (White: 28%, Black: 11%, Hispanic 13%, Asian 14%, p&amp;lt; 0.001). After multivariable logistic regression adjusting for subtype, commercial insurance versus other insurance types, and proximity to the center, White patients remained significantly more likely to receive matched therapy (p=0.029). Conclusions: We observed significant race-based differences in non-English speaking status, insurance type, and median distance traveled to the institution. Racial/ethnic minority patients were less likely to receive genotype-matched therapy than White patients. Further research is needed to identify barriers and reduce disparities in access to precision medicine. Citation Format: Rupali Sood, Lianne Ryan, Andrzej Niemierko, Laura M. Spring, Dejan Juric, Steven J. Isakoff, Seth A. Wander, Jennifer Shin, Naomi Ko, Leif Ellisen, Beverly Moy, Aditya Bardia, Neelima Vidula. Impact of Race on Clinical, Socioeconomic, and Genomic Characteristics, Clinical Trial Participation, and Receipt of Genotype-matched Therapy Among Patients with Metastatic Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD1-10.

Interest and enrollment in clinical trials by race and ethnicity, rurality, and insurance status in patients with ovarian cancer.

83 Background: Enrollment in Phase III clinical trials in gynecologic cancer patients has decreased by approximately 90% since 2011. Efforts to increase enrollment are needed. Previous research showed that not all eligible patients are approached, and those who are do not consistently enroll. Data regarding enrollment by patient characteristics, such as race/ethnicity, rurality, and insurance status is limited. We aimed to identify how these characteristics affect enrollment in ovarian cancer patients. Methods: We conducted retrospective chart review for patients with incident ovarian cancer presenting to the University of Alabama at Birmingham from 1/2017-3/2020. We abstracted patient race, ethnicity, Rural-Urban Commuting Area (RUCA; rural vs urban) and Area Deprivation Index (ADI; most vs least disadvantaged) based on Census tract codes, insurance status, eligibility for available trials, and trial participation from medical records. Patient interest in participation was abstracted from a patient-reported outcomes database. We calculated descriptive statistics and estimated enrollment as a multivariate function of age, race, ethnicity, insurance, RUCA and ADI using binomial logistic regression. We reported associations as odds ratios with 95% confidence intervals. Results: Of 156 patients, 25% were Black, Indigenous, or Persons of Color (BIPOC). 19% lived in a rural area. Mean age was 62 (SD 11.7). Most (95%) patients were insured; 49% Medicare, 40% private insurance, and 6% Medicaid. 126 (81%) were eligible for a trial during their treatment course. Of 102 patients who completed the question on clinical trial interest, 58% were interested; 42% were not. Ultimately, 36% of the 102 enrolled in a trial including 47% of those initially interested and 21% of those not. 39% of white patients (n = 117) initially expressed interest in a trial compared to 33% of BIPOC (n = 39); 48% of white patients ultimately enrolled vs 23% BIPOC. Of patients living in urban vs rural areas with known interest, patients in urban areas had higher interest (44% vs 10%) and higher enrollment (44% vs 31%). Among insurance types, interest and enrollment differed (Medicare (n = 76) 33% and 1%, Private (n = 63) 46% and 46%, Medicaid (n = 9) 33% and 22%, no insurance (n = 8) 25% and 36%). In our adjusted analysis, BIPOC patients had lower odds of enrolling onto clinical trials compared to white patients (OR 0.32, 95% CI 0.13-0.76). Additionally, as age increased by 1 year, odds of enrollment decreased (OR 0.96, 95% CI 0.92-0.99). Conclusions: BIPOC identity and older age were associated with lower rates of clinical trial enrollment. Comprehensive eligibility screening and early introduction could improve enrollment, particularly among BIPOC and older patients. These efforts have potential to improve enrollment as a greater percentage of patients ultimately enrolled on trial than initially expressed interest.

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

101 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 trials-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) were eligible for a trial during PACCT Phase 1. Despite this small sample, the PACCT intervention showed promise in increasing the level of active participation among Black patients and in increasing clinical trial invitations for 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.

Interventions to increase racial and ethnic minority accrual into cancer clinical trials: A systematic review.

Racial and ethnic minorities (REMs) continue to be underrepresented in clinical trials despite the 1993 National Institutes of Health's Revitalization Act mandating the representation of women and underrepresented minority groups in clinical trials. Although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates are disproportionately low at 4% to 6% and 3% to 6%, respectively. A systematic review exploring interventions aimed at improving cancer clinical trial (CCT) enrollment for REMs was conducted. A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies since 1993. Inclusion criteria included peer-reviewed, US-based studies with interventions aimed to recruit underrepresented minority adult patients into cancer clinical trials. REM groups were defined as Black, Hispanic, Asian, American Indian, and Native Hawaiian/other Pacific Islander. The systematic search identified 3123 studies, of which nine met inclusion criteria. Interventions included patient navigation/coaching (n= 4), a clinical trial educational video (n= 2), institutional research infrastructure changes (n= 1), a relationship building and social marketing recruitment model (n= 1), and cultural competency training for providers (n= 1). A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos and an institutional research infrastructure change. This systematic review illustrates several potential mechanisms by which to increase CCT recruitment for patients of REM backgrounds in various clinical settings. More randomized controlled trials are needed to further explore the benefits of these interventions for REMs.

Disparities in endometrial cancer clinical trial participation.

e18514 Background: Clinical trial participation may be a way to mitigate disparities in endometrial cancer. Our objective was to examine the association of clinical trial participation with patient, health system, and cancer factors in endometrial cancer. Methods: We conducted a retrospective cohort study of patients with endometrial cancer diagnosed from 2013-2021 using the nationwide de-identified electronic health record-derived Flatiron Health database. We used multi-level Poisson regression modeling to analyze the association of clinical trial participation (receipt of clinical trial drug) with patient, sociodemographic, health system, and cancer factors. Results: Of 4,662 patients with endometrial cancer, 3.9% (95% CI 3.3-4.5) were ever enrolled in a clinical drug trial. While Black patients accounted for 12% of endometrial cancers and 59% of high-risk histologies (MMT, serous, clear cell), only 3% were enrolled in clinical trials. Black patients were 57% less likely to enroll in a clinical trial (95%CI 0.26-0.72), and this disparity persisted in academic and community settings. Having a more aggressive cancer histology and living in the Southeast were associated with higher rates of clinical trial enrollment. Conclusions: Despite higher rates of aggressive cancer histologies, Black patients were disproportionately under-enrolled in endometrial cancer drug trials. Efforts to increase clinical trial diversity are needed.[Table: see text]

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.

Prediction of clinical trial enrollment rates.

Clinical trials represent a critical milestone of translational and clinical sciences. However, poor recruitment to clinical trials has been a long standing problem affecting institutions all over the world. One way to reduce the cost incurred by insufficient enrollment is to minimize initiating trials that are most likely to fall short of their enrollment goal. Hence, the ability to predict which proposed trials will meet enrollment goals prior to the start of the trial is highly beneficial. In the current study, we leveraged a data set extracted from ClinicalTrials.gov that consists of 46,724 U.S. based clinical trials from 1990 to 2020. We constructed 4,636 candidate predictors based on data collected by ClinicalTrials.gov and external sources for enrollment rate prediction using various state-of-the-art machine learning methods. Taking advantage of a nested time series cross-validation design, our models resulted in good predictive performance that is generalizable to future data and stable over time. Moreover, information content analysis revealed the study design related features to be the most informative feature type regarding enrollment. Compared to the performance of models built with all features, the performance of models built with study design related features is only marginally worse (AUC = 0.78 ± 0.03 vs. AUC = 0.76 ± 0.02). The results presented can form the basis for data-driven decision support systems to assess whether proposed clinical trials would likely meet their enrollment goal.

Characterization of Educational and Behavioral Intervention Trials in U.S. Oncology Specialties

Disproportionate educational deficits in U.S. minority cancer populations have been linked to decreased therapy compliance, suboptimal disease outcomes and low clinical trial enrollment rates. Investigating strategies to improve patient education and health-promoting behaviors is therefore critical to mitigating disparities in oncology. In this study, we characterized for the first time all current educational and behavioral intervention (EBI) studies in U.S. cancer specialties.EBI clinical trials registered on clinicaltrials.gov with completed, active or planned enrollment of adult cancer patients were collated. Clinical trials that were terminated, withdrawn or suspended were excluded from the analysis. EBI trial records were individually appraised and assigned into one of four subtype categories: prevention/screening, treatment experience/compliance, survivorship or clinical trial receptiveness study. EBI trials were further binned based on cancer specialty and type of target demographic. EBI study subtypes were compared between specialties using Chi-squared tests of independence.A total of 654 trials were reviewed, 567 met inclusion criteria. Trial subtype composition is summarized in Table 1. EBI trial subtypes included: 1) 225 prevention/screening (39.7%), 210 treatment experience/compliance (37%), 118 survivorship (20.8%), and 14 clinical trial receptiveness (2.5%). EBI trials with a recruitment focus of racial/ethnic minorities and women were 79 (13.9%) and 128 (22.6%) respectively, most of which are within medical oncology (P < 0.0001). Radiation oncology had no minority focused, survivorship or clinical trial receptiveness studies.We provide the first report of U.S. EBI trials in adult oncology. Interventions targeted towards racial/ethnic minorities are lacking in oncology and are non-existent in radiation oncology. In addition to developing EBI efforts with racial/ethnic minority cancer populations, studies aimed at improving survivorship and clinical trial receptiveness and enrollment within radiation oncology are greatly needed.

Systems-Level Change to Alleviate Barriers to Cancer Clinical Trial Access for Adolescents and Young Adults in Australia.

Purpose:International data demonstrate association between clinical trial participation and reduced cancer mortality. Adolescents and young adults (AYA) have low clinical trial enrollment rates. We established a program to understand local barriers and develop targeted solutions that lead to greater AYA clinical trial participation.Methods:A steering committee (SC) with expertise in adult and pediatric oncology, research ethics, and consumer representation was formed. The SC mapped barriers related to AYA trial access and established working groups (WGs) around three themes.Results:The Regulatory Awareness WG identified a lack of understanding of processes that support protocol approval for clinical trials across the AYA age range. A guideline to raise awareness was developed. The Access WG identified challenges for young adults (18–25 years) to access a pediatric hospital to enroll in a pediatric trial. A procedure was developed to streamline applications for access. The first six applications using this procedure have been successful. The Availability WG identified lack of pediatric–adult oncology reciprocal relationships as a barrier to awareness of open trials, and future collaboration. An AYA Craft Group Framework was established to grow relationships within tumor streams across institutions; two craft groups are now operating locally. An additional achievement was a successful request to the Therapeutic Goods Administration for Australian adoption of the Food and Drug Administration Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.Conclusion:This multipronged approach to improving AYA clinical trial access has relevance for other health environments. Our knowledge products are available as an online toolkit.

Understanding Attitudes and Roles of Oncology Advanced Practitioners in the Setting of Cancer Clinical Trials: A Pilot Study.

PurposeOncology advanced practitioners (APs), including nurse practitioners, physician assistants, clinical nurse specialists, and pharmacists, are skilled health-care providers who contribute significantly to quality cancer care. However, little is known about how APs function within the clinical trials arena. With low rates of clinical trial enrollment among the adult oncology patient population, APs could play an important role in improving clinical trial enrollment.MethodsA descriptive cross-sectional study was conducted based on a 57-item survey of oncology APs' attitudes, beliefs, and roles in relation to cancer clinical trials.ResultsTo assess validity and internal consistency of the survey, a pilot data collection was completed on 14 respondents from Hawaii. The survey's internal consistency across the subscales was moderate to very high, with Cronbach's alpha ranging between 0.55 and 0.86. The majority of oncology APs were interested in being more involved in the clinical trials process, and many are registered as investigators through the National Cancer Institute (NCI). However, few respondents reported being involved in recruitment, consenting, protocol development, or being actively involved with a research base.ConclusionsThis survey was found to be a valid tool to measure APs' attitudes and roles in regards to clinical trials. This survey is just the beginning of data collection in regards to clinical trials among this group of health-care professionals.RecommendationsTo gain further insight into oncology APs and their roles in clinical trials, it is recommended that this survey be implemented on a national level as a first step in moving this issue forward.

Increasing underrepresented minority cancer patient enrollment into cancer clinical trials: A systematic review.

e18574 Background: Minorities continue to be underrepresented in clinical trials despite the National Institute of Health’s Revitalization Act, passed in 1993, mandating the representation of women and underrepresented minority groups in clinical trials. Studies have shown that although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates in are disproportionately low at 4-6% and 3-6% respectively. We conducted a systematic review exploring interventions aimed at improving clinical trial enrollment for racial and ethnic minorities. Methods: A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies of humans since 1993. Inclusion criteria included peer-reviewed, U.S.-based studies with interventions aimed to recruit underrepresented minority adult cancer patients into cancer clinical trials. We defined underrepresented minority groups as Black, Hispanic/Latino, Asian, American Indian/Alaska Native and Native Hawaiian/other Pacific Islander. Results: A total of 2471 titles and abstracts were identified and 2324 were excluded based on the eligibility criteria. A full text review was conducted of the remaining 147 articles, of which only 9 met criteria for our review. The interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1) and cultural competency training for providers (n = 1). Studies were conducted in a variety of practice settings including national cancer institutes and community practices. The quality of evidence was limited by the heterogeneity of study methods, patient representation and bias. Several studies had a homogeneous population of Black patients. Most studies (n = 7) were single arm trials that compared results to either historical controls or those cited in the existing literature; two studies were randomized controlled trials. A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos, the institutional research infrastructure change and the relationship building and social marketing recruitment model. The common threads to many of these successful interventions were support through the cancer care continuum, cultural congruency of research staff and culturally catered clinical trial educational materials. Conclusions: This systematic review illustrates several mechanisms by which to increase cancer clinical trial recruitment for cancer patients of underrepresented minority backgrounds in a variety of clinical settings. Randomized controlled trials with representation of multiple races/ethnicities are needed to further explore the benefits of these interventions.

Health Insurance Payer Type and Ethnicity Are Associated with Cancer Clinical Trial Enrollment Among Adolescents and Young Adults.

Purpose: Adolescents and young adults (AYAs) have experienced inferior improvements in cancer survival outcomes. One potential explanation is the low rate of enrollment in cancer clinical trials. While the reasons behind this are multifactual, sociodemographic factors are probably contributory. We examined the impact of factors such as insurance type and race/ethnicity on clinical trial enrollment among AYAs treated for cancer at an academic medical center. Methods: We identified AYAs (ages 15-39 years) treated for cancer at the University of North Carolina between April 2014 and April 2019. Cancer registry data were linked to electronic health record data to associate treatment and sociodemographic factors with clinical trial enrollment. A multivariable log-binomial model was used to estimate adjusted risk ratios. Results: In a 5-year period, 1574 AYA patients were identified, 59% female, 21% non-Hispanic Black and 9% Hispanic. Overall, 37% of AYAs participated in any clinical trial and 14% enrolled on a therapeutic trial. When compared to publicly insured AYAs, those with private insurance [adjusted RR: 1.52, 95% CI: 1.05-2.22] or with no insurance [adjusted RR: 2.12, 95% CI: 1.34-3.33] were more likely to enroll in a therapeutic clinical trial. Hispanic AYAs were less likely to enroll [adjusted RR: 0.50, 95% CI: 0.27-0.93] when compared to non-Hispanic White patients. Conclusions: Rates of clinical trial enrollment among AYAs vary based on health insurance type and race/ethnicity, suggesting possible disparities in access. Attention to resource, cultural, and language barriers may improve trial enrollment and cancer outcomes among vulnerable AYA subpopulations.

EPID-35. CLINICAL TRIAL ENROLLMENT RATE AMONG ADOLESCENT AND YOUNG ADULTS WITH CENTRAL NERVOUS SYSTEM TUMOR AT DANA-FARBER CANCER INSTITUTE (DFCI)

Abstract BACKGROUND Adolescents and young adults (AYAs; 15–39 yrs.) are a population recognized as facing significant challenges in cancer care and research, characterized by historically poor participation in clinical trials. The clinical trial enrollment rate among AYAs with CNS tumor is unclear. We report the findings from our study evaluating the clinical trial enrollment rate of AYAs with CNS glioma at DFCI, comparing the rates between its affiliated adult and children’s hospitals. METHODS We performed a retrospective cohort study of patients with primary CNS glioma treated at our center between 2008–18. Eligible patients were identified using institutional databases at Boston Children’s Hospital and Brigham and Women’s Hospital. Manual chart review and data abstraction from the electronic medical record were performed to obtain key variables. Clinical trial enrollment rates were reported, followed by univariate and multivariate logistic regression models to identify factors affecting clinical trial enrollment. RESULTS In the adult setting, a total of 608 AYA patients with glioma were identified to meet our inclusion criteria and presented with a median age of 32 years (range:15–39). 92 out of 608 (15%) patients enrolled in a clinical trial during their treatment course. Within this cohort, tumor type was significantly associated with clinical trial enrollment, with higher-grade tumors associated with better enrollment rates (p&amp;lt; 0.001). On the contrary in the pediatric setting, a total of 52 AYA patients were identified from the children’s hospital, with a median age of 17.2 years (range:15–25.4) of whom, 19 out of 52 (36.5%) patients were enrolled on a clinical trial. CONCLUSION Clinical trial enrollment rate remains poor among AYAs with CNS tumors, with tumor type/histology grade associated with enrollment rate. Higher enrollment rates were seen among early AYAs treated at the children’s hospital.

MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial.

For rare cancers, challenges in establishing standard therapies are greater than those for major cancers, and effective methods are needed. MASTER KEY Project is a multicenter study based in Japan, with two main parts: prospective registry study and multiple clinical trials. Advanced rare cancers, cancers of unknown primary origin, and those with rare tissue subtypes of common cancers are targeted. The registry study accumulates highly reliable consecutive data that can be used for future drug development. The multiple trials are conducted simultaneously, targeting either a specific biomarker or a rare tumor type of interest. The first interim data set from the registry part presented here shows the prevalence of genetic abnormalities, response rates, survival rates, and clinical trial enrollment rates. From May 2017 to April 2019, 560 patients (mean age = 53) were enrolled in the project. Frequent cancer types included soft tissue sarcomas, neuroendocrine tumors, and central nervous system tumors. Among the 528 patients with assessable data, 69% (364/528) had next‐generation sequencing tests, with 48% (176/364) harboring an “actionable” alteration. Seventy‐one (13%) patients have been enrolled in one of the clinical trials, with an accrual rate of 3.94 patients/month. A descriptive analysis of biomarker‐directed or non‐biomarker‐directed treatment survival was performed. This project is expected to accelerate development of treatments for rare cancers and show that comprehensive platform trials are an advantageous strategy.

Readability of Cancer Clinical Trials Websites.

Clinical trials are critically important for the development of new cancer treatments. According to recent estimates, however, clinical trial enrollment is only about 8%. Lack of patient understanding or awareness of clinical trials is one reason for the low rate of participation. The purpose of this observational study was to evaluate the readability of cancer clinical trial websites designed to educate the general public and patients about clinical trials. Nearly 90% of Americans use Google to search for health-related information. We conducted a Google Chrome Incognito search in 2018 using the keywords “cancer clinical trial” and “cancer clinical trials.” Content of the 100 cancer clinical trial websites was analyzed using an online readability panel consisting of Flesch-Kincaid Grade Level, Flesch Reading Ease, Gunning-Fog Index, Coleman-Liau Index, and Simple Measure of Gobbledygook scales. Reading level difficulty was assessed and compared between commercial versus non-commercial URL extensions. Content readability was found to be “difficult” (10.7 grade level). No significant difference in readability, overall, and between commercial and non-commercial URL extensions was found using 4/5 measures of readability; 90.9% of commercial versus 49.4% of non-commercial websites were written at a >10th grade (P = .013) using Gunning-Fog Index. Written cancer clinical trials content on the Internet is written at a reading level beyond the literacy capabilities of the average American reader. Improving readability to accommodate readers with basic literacy skills will provide an opportunity for greater comprehension that could potentially result in higher rates of clinical trial enrollment.

Comparison of Health Outcomes in Adolescent and Young Adults (AYA) Oncology Patients Treated at a Pediatric Versus Adult Institute

BACKGROUND Overall survival for adolescent and young adult (AYA) cancer population, ages 15 to 39 years, demonstrated minimal improvement during the last several decades. Potential factors influencing inferior outcomes within this group include the complex biology of AYA cancers, lower rates of clinical trial enrollment, the significant toxicities caused by therapies, and unmet psychosocial needs. AYA patients can often be treated in either pediatric or adult institutions. The type of institution where they receive treatment is influenced by age, type of cancer, and distance from a pediatric oncology center. There are concerns that differences in care between pediatric and adult treatment settings are influencing the slow progress in improving outcomes. Acute care utilization might reflect the burden of toxicities and access to care, which might vary based on treatment setting. There is limited research suggesting that AYAs treated at pediatric institutes are more likely to be enrolled in clinical trials. The AYA population also has challenging psychosocial needs and it is unknown if there is a difference in how those needs are addressed in different treatment settings. The objective of this study was to examine whether there are differences in clinical trial enrollment, acute care utilization, and psychosocial support between AYA oncology patients treated at a pediatric versus an adult facility. Our hypothesis was that AYAs treated at a pediatric facility will have increased enrollment in clinical trials, less acute care utilization, and more psychosocial referrals compared to AYAs treated at an adult facility. METHODS We conducted a retrospective cohort study of patients ages of 15 to 39 years who were diagnosed with a hematologic malignancy (acute lymphoblastic leukemia (ALL), acute myelocytic leukemia (AML), Hodgkin lymphoma (HL) and Non-Hodgkin Lymphoma (NHL)) and were cared for at a pediatric or adult facility during the years 2013-2017. The primary health outcomes examined were acute care utilization and psychosocial resources utilized, based on a patient's exposure time (defined as one year from diagnosis or 1 month after completion of therapy, whichever came first). Data were analyzed using SAS 9.4. To compare the health outcomes between patients treated at the two facilities, the Chi-square test or Fisher's exact test was used for categorical variables. For continuous variables, due to the skewness of the data, a log transformation was applied to the length of stay (LOS) variable, and then the Student's t-test was used. The Mann-Whitney test was used for the other continuous variables. This study was approved by the Children's Hospital of Wisconsin Institutional Review Board. RESULTS A total of 196 patients were treated as either newly diagnosed or relapse/progressive patients who received care at the pediatric or adult treatment facilities. Leukemia patients treated at a pediatric facility were more likely to be enrolled on a clinical trial than patients treated at an adult facility (84% vs 22%, p&lt;0.0001). There was no statistically significant difference in enrollment in clinical trials for lymphoma patients at both treatment facilities (4% vs 8%, p=0.68) as shown in Table 1. There was no significant difference in acute care utilization for ED visits or inpatient hospitalizations for all diagnoses for the pediatric and adult facilities. Both ALL and HL patients had more ICU admissions per month at the pediatric facility compared to the adult facility (ALL: mean 0.25 vs 0.05, p=0.021; HL: mean 0.03 vs 0, p=0.0027). ALL and HL patients had longer hospitalization LOS at the adult facility (ALL p=0.020, HL p=0.014) There were more referrals for psychology, social work or case management and palliative care in the pediatric versus adult facility (p&lt;0.0001, p=0.011, p&lt;0.0001, respectively). CONCLUSION For AYA patients treated at a pediatric institute, leukemia patients have higher rates of clinical trial enrollment and all patients receive more psychosocial support compared to AYA patients treated at an adult institute. There was no difference in acute care utilization for ED visits or hospitalizations between patients treated at a pediatric or an adult facility. Patients with ALL and HL have more ICU admissions but overall shorter hospital LOS at the pediatric institution. Further work to determine the impact of these findings on the long-term outcomes and survival of AYA patients is needed. Disclosures Panepinto: NIH: Research Funding.

Role of Racial, Demographic and Socioeconomic Disparities in Treatment Patterns and Outcomes in AML

Role of Racial, Demographic and Socioeconomic Disparities in Treatment Patterns and Outcomes in AML