bluuebunny/crossref_metadata_2025_split huggingface dataset:
Associations between insurance status and the cancer clinical trial enrollment process.
Authors: Caston Nicole E. , Lalor Fallon , Wall Jaclyn , Sussell Jesse , Patel Shilpen A. , Williams Courtney , Azuero Andres , Arend Rebecca Christian , Liang Margaret Irene , Rocque Gabrielle Betty 
Published: September 2022

85 Background: Most patients with cancer experience multi-leveled barriers to clinical trial participation, potentially including financial concerns due to the complexity surrounding trial-related insurance coverage. Our study sought to understand the association between insurance status and cancer clinical trial eligibility, offer, and enrollment. Methods: This retrospective cohort study included patients with breast or ovarian cancer receiving a therapeutic cancer drug at the University of Alabama at Birmingham between January 2017 and February 2020. Available clinical trials and eligibility criteria were abstracted from OnCore and ClinicalTrials.gov. Patient trial eligibility, offer from provider, demographics, and clinical characteristics were abstracted from electronic medical records. Patient trial enrollment was determined via OnCore. Odds of clinical trial eligibility, offer, and enrollment by insurance status (private, public [Medicaid, Medicare]) were estimated using logistic regression models. Models estimating odds of trial offer and enrollment contained only eligible patients. Models were adjusted for patient age at diagnosis, race and ethnicity, rural-urban residence, Area Deprivation Index, cancer type, and cancer stage (early, late). Results: A total of 513 patients with breast (71%) or ovarian (29%) cancer were included in our analyses. Median age at diagnosis was 60 (interquartile range: 49-67) years; the majority were White (69%) and had early stage cancer (65%). Half of patients had private insurance (54%), and 46% of patients had public insurance (38% Medicare, 8% Medicaid). Patients with private insurance more often had early stage cancer compared to patients with public insurance (73% vs 57%). Almost two-thirds of patients (65%) were eligible for clinical trial enrollment. Of eligible patients (n = 333), 68% were offered a trial and 47% enrolled onto a trial. In adjusted analyses, patients with public vs private insurance had similar odds of clinical trial eligibility (odds ratio [OR] 0.95, 95% confidence intervals [CI] 0.61-1.48), being offered to participate (OR 1.23, 95% CI 0.71-2.14), and clinical trial enrollment (OR 1.13, 95% CI 0.68-1.89). Conclusions: Our results suggest oncologists do not assess trial eligibility or offering a trial based on insurance status, and patients do not differentially participate based on their insurance coverage. Further research is needed to understand implications of trial participation (e.g., out-of-pocket and time costs) for patients covered by differing insurance.
Best practices in achieving patient diversity in oncology clinical trials.
Authors: Curry Andrea , Vidal Gregory A. , Greener Judith R 
Published: September 2022

87 Background: The underrepresentation of Black patients in cancer clinical trials in the United States has been well documented. While a multitude of recommendations exist from government organizations, academic institutions, industry sponsors, and commercial groups on approaches designed to increase enrollment, there is a lack of evidence as to the effectiveness of these recommendations in real-world settings. The West Cancer Center & Research Institute (WCCRI), a community oncology center in the greater Memphis, TN area, has consistently conducted trials in which Black patients are well-represented. Of all oncology clinical trials conducted at WCCRI in 2021, Black patients represented 29.9% of the total enrolled population. To further extend the literature on successful methods to achieve greater trial diversity, enrollment tactics used by WCCRI were explored to understand best practices and assess scalability to other oncology centers. Methods: A total of 35 qualitative in-depth interviews were conducted with multiple constituencies associated with WCCRI to obtain a holistic view of clinical trial practices. Interviews were held between March and April 2022. Included were Black patients who participated in a clinical trial, Black patients that declined participation in a clinical trial, caregivers of these patients, WCCRI staff, and community leaders in the Memphis, TN area. All patients interviewed had a history of solid malignancies and were treated at WCCRI between January 2018 and December 2021. The study was considered minimal risk research and all participants provided informed consent before study participation. Results: This research underscored the fact that barriers to enroll Black patients are complex and involve challenges at various structural levels including the system, individual, and interpersonal levels. WCCRI practices were found to incorporate tactics at each of these levels, leading to the ability of this community oncology center to enroll representative proportions of Black patients into its oncology trials. Examples of tactics that reach into the community include coordinating with local leaders to provide residents with health education; outreach by Black WCCRI staff, diverse PIs, and ambassadors to dispel myths about a cancer diagnosis and treatment; and faith-based leaders guiding patients to helpful resources and supportive services provided by WCCRI. Conclusions: Results of this research build upon previous literature that suggest although some success has been identified through interventions at any one level, the greatest opportunity for achieving diversity in oncology trials comes from multilevel interventions. Emphasis should be placed on crafting tactics that simultaneously address factors in each of these levels to consistently achieve enrollment diversity.
Racial disparities among patients with multiple myeloma enrolled in clinical trials.
Authors: Nishat Nabilah , Bari Thoasin , Islam Shahidul , Braunstein Marc Justin 
Published: September 2022

89 Background: Tremendous therapeutic progress has been made over the past decade in the field of multiple myeloma (MM). Although the incidence of MM is twice as high for black compared to white individuals, mortality rates remain higher for black patients (Marinac, et al. Blood Ca J 2020). In addition, black Americans are significantly less likely to participate in clinical trials in general (Hong, et al. Am J Prev Med 2021), leading to disproportionate enrollment in studies of novel agents. Various factors may account for these disparities, including access to clinical trials, clinician bias, and hesitancy to enroll in clinical trials among different patient populations. Furthermore, underrepresentation of racial groups within clinical trials impacts the generalizability of important findings from these studies. Here we characterized the racial representation of MM clinical trials. Methods: Randomized clinical trials focused on MM interventions published between 2012-2022 were included. We screened 431 publications during this period and characterized racial demographics as available in the literature. A two-sided Cochran-Armitage Trend Test was used to assess if there was a linear trend in the percentage of black participants in clinical trials over time. Results: Among 431 studies published over the past 10 years, 76 collected over past 5 years that included racial demographic details were included. Among the 38,830 participants, 87.5% were white, 4.8% were black, and 7.7% were other (reported as either “Asian”, “mixed”, or “other”). There was a significant trend toward increased enrollment comparing over time between 2018 to 2021 (2.1 to 7.0%, p < 0.001 for trend), however black individual remained largely underrepresented in all these studies. Conclusions: While the number of black participating in randomized controlled trials involving MM patients over the past five years is significantly increasing, these studies included a disproportionate number of white participants, despite the incidence of MM being higher for black patients. Efforts are underway in the field to enhance enrollment of underrepresented populations, including a recent randomized study that included 19% black MM patients (Richardson, et al. New Eng J Med 2022). Our study was limited due to many trials not reporting details about racial demographics until relatively recently. Further investigations required to examine the reasons underlying racial disparities in MM trial recruitment and enrollment.
Understanding feasibility and patient experiences with a ride share program to facilitate uninsured, Hispanic participation in clinical trials: A pilot survey study.
Authors: Raygoza Jhenitza , Rosenblatt Robert , Austin Jessica , Omar Farhia , Cuellar Idali , Northfelt Donald W. , Pisano Etta , Patel Bhavika K. 
Published: September 2022

91 Background: Most screening clinical trials are not representative of the populations susceptible to disparities in breast cancer outcomes. Strategies are needed to address known structural barriers to clinical trial participation. We partnered with a federally qualified health center to provide no-cost ride-share services as a strategy to facilitate enrollment of uninsured, Hispanic women in Maricopa County, Arizona into a national trial offering no-cost mammography screening. Objective: This pilot survey study explored the feasibility and experiences of uninsured, Hispanic women with a no-cost ride share program as part of the National Cancer Institute funded ECOG-ACRIN clinical trial, TMIST, studying mammography screening at the Mayo Clinic Arizona in Phoenix. Methods: Participants completed a validated survey by phone and interview-style. Survey items assessed women’s use of and experiences with the ride share service including barriers, benefits, and if the ride share service facilitated their participation in the screening trial. Descriptive statistics were calculated using SAS. Results: A total of 30 women completed the survey (response rate = 30/33). All women first-time Mayo Clinic trial participants and 90% lived at least 30 minutes away from trial facility. The mean age of women was X years, 90% had a high school degree or less, and 97% were Spanish speaking. Most women (73.7%) said that travel distance was a barrier to participation in prior clinical trials. A large proportion of women (73%) reported using ride share services for this trial and all agreed that the ride service made it easier for them to attend their trial visit. Nearly 1/3 (64%) said that they were uncertain or would not have been able to participate without the ride-share as an option. Among women using the ride share service, the main benefits of the program included at-home pick up and the service being of no-cost. Other benefits included flexible timing (86%) and one-on-one service (86%). The primary barrier of the program was the driver not speaking the dominant native language (27.3%). Conclusions: Despite lengthy travel distances, women reported overwhelming positive experiences with the no-cost ride share program and agreed that the service helped facilitate their participation in the clinical trial. Thus, no-cost ride share programs are a promising and feasible strategy to reduce barriers to clinical trial participation among historically underserved populations. Future studies should continue to explore the benefits and sustainability of ride-share programs, including benefits to clinical trial retention.
Reasons for declining a pharmacist-led telehealth study among oncology patients initiating oral anti-cancer drugs.
Authors: Lichtenstein Morgan RL , Harden Erik , Collins Nicole , Faheem Khadija , Campbell Peter , Patel Khilna , Nguyen Michelle K. , Abramova Rachel , Beauchemin Melissa Parsons , Hershman Dawn L. 
Published: September 2022

94 Background: During the COVID-19 pandemic, remote cancer care, and video communication in particular, has become increasingly common in the context of routine visits and clinical trials. Though this medium has the potential to augment patient-provider communication, telehealth also raises concerns about the digital divide promoting disparities in access to cancer care. In this study, we surveyed oncology patients who declined to participate in a pilot study looking at a one-time pharmacist-led video visit for patients initiating oral anti-cancer medications to evaluate their primary reason for declining the intervention. Methods: Between June 2021 and June 2022, we conducted a prospective survey among adult oncology patients at Columbia University Medical Center (CUMC) who declined a pilot study looking at a video visit intervention for patients initiating oral anti-cancer medications to assess the primary barriers to participation. The survey categorized specific reasons for decline into telehealth-related barriers (no access to electronic device, inability to navigate video visits specifically, patient preference for in person care) and trial-related barriers (patient too tired/unwell, no time to participate, not interested in this study specifically, not interested in clinical trial participation in general), and patients were asked to select the primary reason for declining among the list of options. Results: Twenty-three patients completed the survey (82% completion rate). Among 23 respondents, 9 patients (39%) described a technology-related barrier to participation, including 7 (30%) who owned a mobile device with video capacity, but did not know how to use video technology well enough for the visit, 1 (4%) who did not own a device with video capacity, and 1 (4%) who preferred in person visits. Fourteen respondents cited a reason unrelated to telehealth for declining participation, including 7 (30%) who did not feel the study would benefit them, 3 (13%) who did not have time, 2 (9%) who were too tired to participate in a study, and 2 (9%) who were not interested in participating in any kind of clinical trial. Conclusions: Video-based telehealth visits have become increasingly common in routine cancer care and clinical trials. Among oncology patients who declined participation in a pilot study looking at a pharmacist-led video consultation, over a third cited telehealth-related barriers to participation, the majority of whom had a mobile device, but did not know how to use video technology well enough to participate. Focusing efforts on training patients to use technology, particularly video communication, may help address the digital divide in cancer care.
Reasons for declining participation in breast cancer trials among minorities at a safety-net health system.
Authors: Robles Fabian E. , Qureshi Nasir , Unni Nisha , Syed Samira K. , Li Hsiao Ching , Sadeghi Navid 
Published: September 2022

95 Background: Despite increasing awareness, racial and ethnic minorities remain under-represented in clinical trials. Understanding patients’ reasons to decline participation can help tailor solutions to improve minority enrollment in cancer trials. Methods: Parkland Health (Dallas County, TX) is a safety-net health system, and affiliated with the UT Southwestern/Harold C. Simmons Comprehensive Cancer Center (SCCC). Over 80% of the breast cancer patients treated at Parkland belong to racial and ethnic minorities. Potential study candidates are referred to the clinical trial support team, which includes a Hispanic bilingual patient navigator. Patients who decline to participate are asked to describe their reasons. Data for screening and accrual to therapeutic breast cancer trials at Parkland between January 2021 and May 2022 is presented here. Results: A total of 193 potential study candidates were referred to the trial support team in the pre-screening phase. Ninety-five patients (49%) were excluded after screening (screen-fails). Of the 98 patients who met all study specific eligibility criteria, 93% belonged to minorities: 69% (68/98) Hispanics and 23% (23/98) Blacks. Thirty-one patients (32%) declined participation in clinical trials. Compared to Hispanics, Black patients were more likely to decline participation: Blacks 65% (15/23) vs Hispanics 19% (13/68); p < 0.0001. Patients' reasons for declining to participate in trials included: lack of interest (14/31), excessive trial requirements such as extra biopsies (8/31), and potential delay in treatment due to additional tests (5/31). Four patients declined participation in a de-escalation trial due to the fear of inferior outcomes with less treatment. Among patients who declined participation, 53% of Blacks and 23% of Hispanics cited lack of interest as the reason (p = NS). Conclusions: We observed a higher participation rate among Hispanics, which may in part reflect the impact of having a bilingual research navigator from the same ethnic background. Lack of interest was a major reason to decline, particularly among Blacks. Strategies focused on patient education and trust are being implemented to further improve minority participation in trials at our institution.
Access to Medicaid dental services and distant-stage oral cancer diagnoses in Utah: A quasi-experimental approach.
Authors: Semprini Jason 
Published: September 2022

106 Background: Late detection may contribute to disparities in oral cancer outcomes, as most low-income oral cancer patients are diagnosed at distant stages. Because dentists are the most likely provider to screen for oral cancer, access to Medicaid dental services could improve outcomes. However, states are not mandated to cover adult Medicaid dental benefits. In 2010, Utah’s Medicaid program added dental benefits. My study leverages this policy change to test if dental coverage is associated with distant stage diagnoses and if this association changes with the number of dentists per capita. Methods: I analyzed SEER data for all oral cancers diagnosed between 2007-2013. The outcome is a binary variable, indicating if the oral cancer patient was diagnosed at a distant stage. All analyses control for age, race, and gender as well as state and year fixed-effects. Under a Difference-in-Differences design, where DD = Post2010*Utah, I estimate the effect of adding dental coverage for Medicaid enrollees in Utah compared to Medicaid enrollees in states that did not change their Medicaid program. Then, to account for differential trends, I implement a Triple Differences design, where DDD = Post2010*Utah*Medicaid, and estimate the effect of adding dental coverage for Medicaid enrollees in Utah compared to adults in Utah who are not on Medicaid. Finally, I interact the DDD variable with a variable measuring Utah's dentists per 100,000 population (county-level data from AHRQ). Results: Compared to Medicaid enrollees in other states, adding Medicaid dental coverage in Utah was associated with a decline in the probability of a distant-stage oral cancer diagnosis (DD = -0.046; ci = -0.078, -0.014). The Triple Difference result was similar (DDD = -0.074; ci = -0.107, -0.041). The heterogeneity analysis reveals that the association between adding Medicaid dental coverage and distant stage diagnoses are small and insignificant in Utah counties without dentists. However, the interaction term between adding dental coverage and dentists per capita yields a significant decline for every additional dentist in the county (DDD*Dentists/100,000Capita. = -.001 ci = [-0.002, -0.0009]. Putting these results into context, the marginal effect of adding dental coverage in counties with 80 dentists/100,000 is associated with a 0.104-percentage point decline in distant diagnoses: a 20% decline relative to pre-2010 rates. Conclusions: Access to dental services could improve outcomes for low-income oral cancer patients, but the persistent barriers to dental care may perpetuate disparities.
Multi-level determinants of endometrial cancer diagnosis as experienced by Black women.
Authors: Asad Sarah S , Brewster Wendy R. , Kent Erin E. , Choi Youngjee , Spees Lisa , Birken Sarah A 
Published: September 2022

107 Background: Black women experience inequity in access to timely endometrial cancer (EC) diagnosis compared to non-Hispanic white women. Delays in obtaining a timely diagnosis and referral for treatment can amplify poorer outcomes in Black women. Communication between Black patients and providers are likely influenced by determinants at multiple levels (e.g., individual, community, systems). Examining determinants at multiple levels can provide insight on how they influence guideline-concordant EC diagnosis in Black women through patient-provider communication. This study reports on Black women’s EC diagnosis experience, from the time of symptom onset to obtaining a diagnosis. Methods: We conducted a qualitative study using semi-structured interviews guided by the socio-cultural framework for the study of health service disparities (SCF-HSD). We used deductive thematic analysis using codes from the SCF-HSD framework, and inductive thematic analysis for new themes arising in the data. Participants were recruited using a study posting on an online patient research platform associated with an academic hospital in North Carolina. Eligible patients had to identify as Black, English-speaking, aged 40 years or older, and have a diagnosis of EC within the last 3 years. Results: Thirteen Black women with EC participated in online & phone interviews ranging from 22-50 minutes. Participants were primarily between 40-49 years of age (mean age = 45), stage II (100%), and either had private (47%), Medicare (23%) or Medicaid (30%) health insurance. Participants identified determinants at 3 levels: individual (symptom misinformation; delay in seeking support for symptoms - competing needs with work and family; fear and anxiety while waiting for tests and results), community (convenience of primary care clinics; existing relationships with providers; delay in referral by primary care providers; lack of information on testing rationale and expectations), and environment (distance to cancer centers; difficulty in obtaining appointments). Many participants reported that the onus was on them to find a cancer center and oncologist to conduct further diagnostic testing after seeing a primary care provider for their symptoms. When asked whether participants felt they were treated differently (positively/negatively) because of their race, many participants mentioned being Black negatively affected their ability to obtain timely appointments for diagnostic testing (e.g. biopsy, vaginal ultrasound). A few participants specifically mentioned reaching out to Black providers for management of their cancer. Conclusions: Black women with EC report several determinants to timely diagnosis at multiple levels. These findings will be mapped onto implementation strategies in a system-strengthening intervention to improve guideline-concordant diagnosis.