Participation In Cancer Clinical Trials Research Articles

Using Technology to Enhance Cancer Clinical Trial Participation.

The COVID-19 pandemic presented many challenges to health care systems, including oncology clinical research programs. There were substantial negative effects on oncology clinical trial screening, enrollment, and study activities that forced institutions and regulatory bodies to develop innovative solutions to maintain robust and equitable participation in these trials. Digital pathology innovations at Memorial Sloan Kettering Cancer Center have streamlined the diagnostic life cycle for patients with cancer, and the seamless integration of digital pathology services with next-generation sequencing and other molecular pathology services have accelerated the time to diagnosis and receipt of molecular results. Timely access to these results, coupled with Memorial Sloan Kettering Cancer Center's knowledge engine OncoKB, enhances patient clinical trial coordination precisely and efficiently. At the Sarah Cannon Research Institute, centralized remote clinical trial matching and screening, virtual molecular tumor boards, and centralized molecular interpretation support services have empowered clinic staff to identify more efficiently potential participants in clinical research, despite the COVID-19 pandemic. In addition, the U.S. Food and Drug Administration Oncology Center of Excellence has been involved in several efforts to address challenges for patients with cancer during the COVID-19 pandemic, including writing guidance documents and participating in efforts to modernize clinical trials. The enclosed personal experience of a patient with cancer currently participating in an oncology clinical trial emphasizes the need for continued decreasing of barriers to study participation. Clinical trial advances that were accelerated by the pandemic will ultimately help patients with cancer and the greater oncology health care community.

Financial Toxicity, Symptom Burden, Illness Perceptions, and Communication Confidence in Cancer Clinical Trial Participants.

Cancer clinical trial (CCT) participants are at risk for experiencing adverse associations from financial toxicity, but these remain understudied. From July 2015 to July 2017, we prospectively enrolled CCT participants referred for financial assistance and a group of patients matched by age, sex, cancer type, trial, and trial phase. We assessed financial burden of cancer care, cost concerns about CCTs, physical (Edmonton Symptom Assessment Scale [ESAS]) and psychologic (Patient Health Questionnaire-4 [PHQ-4]) symptoms, illness perceptions (Brief Illness Perception Questionnaire), and communication confidence (Perceived Efficacy in Patient-Physician Interactions). Adjusting for age, sex, race, performance status, marital status, income, insurance, and disease status, we examined associations of financial burden and cost concerns with patients' symptoms, illness perceptions, and communication confidence. Of 198 patients, 112 (56.6%) reported financial burden and 82 (41.4%) reported cost concerns. Higher ESAS-total (odds ratio [OR] = 1.03; 95% CI, 1.01 to 1.06; P = .001), PHQ-4 depression (OR = 1.58; 95% CI, 1.20 to 2.08; P < .001), PHQ-4 anxiety (OR = 1.26; 95% CI, 1.02 to 1.55; P = .025), and more negative illness perceptions (OR = 1.04; 95% CI, 1.00 to 1.07; P = .029) were associated with financial burden, but not communication confidence (OR = 0.98; 95% CI, 0.02 to 1.05; P = .587). Higher ESAS-total (OR = 1.03; 95% CI, 1.01 to 1.05; P = .004), PHQ-4 depression (OR = 1.36; 95% CI, 1.08 to 1.71; P = .03), PHQ-4 anxiety (OR = 1.26; 95% CI, 1.03 to 1.53; P = .018), more negative illness perceptions (OR = 1.06; 95% CI, 1.02 to 1.10; P = .001), and decreased communication confidence (OR = 0.93; 95% CI, 0.86 to 1.00; P = .029) were associated with cost concerns. In this study of CCT participants, greater symptom burden, more negative illness perceptions, and lower communication confidence were associated with financial toxicity, underscoring the importance of addressing these issues when seeking to alleviate adverse associations of financial toxicity.

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.

Assessing feasibility and utility of an implicit bias training program for addressing disparities in cancer clinical trial participation.

e18599 Background: Low participation of Black, Hispanic, Latinx and other underrepresented racial/ethnic groups in clinical research remains a problem across the U.S. Recent studies have highlighted that stereotypes, assumptions, and bias play a role in lack of diversity in cancer trial participation. To help address this, the Association of Community Cancer Centers (ACCC) and American Society of Clinical Oncology (ASCO) piloted an implicit bias training program for clinical research teams. Methods: Adapted from the Duke University Just Ask™ program, the pilot program is comprised of eLearning modules which can be completed in about 60 minutes. Features include education on diversity, equity, and bias in clinical trial participation, case vignettes, and strategies to mitigate disparities. A call was issued to members of both organizations. After completing the training, all individual participants were asked to complete a retrospective pre/post survey to assess change in knowledge and attitude. Focus groups explored participants’ experience with the training. Another survey was administered 6 weeks later to assess sustainability of changes. Results: Research teams from 50 programs were selected for the pilot. 129 individuals consented, and 126 completed the training and evaluations (98% response rate). 48% of participants reported that they had completed training on implicit bias and/or related topics prior to the pilot. Increased levels of knowledge were reported across all key training concepts, with an average % increase from 19% to 45%. Similar increases were observed for strategies for addressing implicit bias, with an average % increase from 10% to 31%. At 6 weeks post-training, there was a slight decrease in knowledge across most items, from -1% to -8%. Most (92%) participants reported satisfaction with the course, and most (92%) indicated they would recommend it to a colleague and would recommend implementing it at their program. Suggestions to improve the course included streamlining content and providing additional tools and resources. Conclusions: Pilot findings support the feasibility and utility of the training, which can help cancer programs to address disparities in clinical research. Next steps include modifying the course based on participant feedback, disseminating the training and supplementary resources, and exploring options for assessing the impact on upstream outcomes such as diversity in trial participation.[Table: see text]

Analysis of demographic characteristics and disparities of enrollment in cancer clinical research at the U.S. National Cancer Institute (NCI): A 15-year experience.

6529 Background: Racial, gender, and socioeconomic disparities in cancer clinical trials participation have been well documented. The intramural program of the NCI in the National Institutes of Health (NIH) Bethesda campus conducts clinical research where participants are referred by their physician or self-referred, treated without charge and receive aid in travel expenses. We sought to describe the demographics of participants and identify potential disparities. Methods: We used the clinical research data repository of the NIH, Biomedical Translational Research Information System (BTRIS), to extract self-reported demographic data of enrollees in NCI protocols from 2005-2020. Comparisons were made with the U.S. population of patients with cancer as captured in the Surveillance, Epidemiology, and End Results (SEER) Program (2005-2018). The average household income per zip code was derived from the American Community Survey at five-year increments from 2011, 2015, and 2019. Results: We obtained data on 40,007 participants; 38,531 (95%) came from the U.S., of which 18,606 (48%) from DC, Maryland, or Virginia (DMV). Median age at consent was 54 years (range 2 – 89). Proportions of basic demographic attributes and corresponding values from SEER data were presented. Notably, Hispanic male, non-Hispanic female, and white female participants were under-represented in NCI clinical research compared to SEER data. African Americans were under-represented in the non-DMV population (5%) vs. the DMV (19%). Also, for patients from the DMV area, median income was consistently less for African American participants compared to White and Asian participants. Conclusions: The identified disparities may be partially due to the specific research activities available at the NCI, but strategies aiming at increasing the participation and representation of under-represented groups are required. [Table: see text]

Patient education intervention to improve breast cancer clinical trials participation.

e18532 Background: Patient education has been shown to improve clinical trial participation. Medically underserved, racial, and ethnic minorities have lower participation rate in cancer clinical trials (CCT) than patients of high socioeconomic status (SES). Our comprehensive cancer center is notable for providing equal access to breast CCT through a private system (Baylor McNair) and a public safety net hospital (Harris Health Smith Clinic). Our prior research has shown that breast cancer patients at Smith Clinic (SC) who are 60% uninsured, predominantly of low SES, and 80% racial and ethnic minorities are 40% less likely to enroll compared to McNair patients where patients are &gt; 95% insured and largely Caucasian. Methods: We developed a 7-minute video consisting of current patients’ testimonies of their CCT experience along with the research team discussing misconceptions regarding CCT and biospecimen collection. The video was designed to be culturally sensitive and used simplified terms in English, Spanish, and Vietnamese. We modified a validated questionnaire by UT Health San Antonio, Institute for Health Promotion Research to assess participants attitudes towards CCT participation before and after watching the video. We used a Wilcoxon Signed Rank test for measuring the effect of the video on a 5-point Likert scale with 5 indicating “Extremely likely”, 3 “Moderately Likely” and 1 “Not Likely at all”. The primary outcome was a shift in stated likelihood of participation in a CCT by 1 point. Using Chi-squared test, we assessed whether English proficiency or residing in the United States (US) for more than 10 years affected the results. Patients’ reason for refusing CCT was documented. With 200 survey responders, the study had 97% power to detect the desired primary outcome. The project was supported by a Pfizer education grant. Results: A total of 200 patients (73 at McNair and 127 at SC) watched the video and completed the surveys. The mean pre-intervention score for likelihood of willingness to participate in a CCT was 3.34 (SD 1.45) at McNair and 2.81 (SD 1.28) at SC. The mean post-intervention score was 3.89 (SD 1.28) at McNair and 3.44 (SD 1.22) at SC. While the pre- and post- intervention scores were significantly different across the two sites (p = 0.01 and p = 0.015 respectively), the study did not meet its primary objective. There were also no significant differences in the willingness to participate in CCT with regards to time spent in the US or English proficiency. Most frequent reasons for refusal were concern about extra costs, extra time commitment and the need to discuss the trial with family members. Conclusions: Our in-house developed patient education video did not improve patients’ willingness to participate in CCT as much as we had hoped. This suggests that a comprehensive approach is required to improve our community’s engagement and close the disparity gap in the treatment and outcomes of breast cancer.

Increasing Black patient participation in metastatic breast cancer clinical trials: The BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project.

1014 Background: Among U.S. racial/ethnic groups, Black people with breast cancer have the highest death rate and shortest survival. Although ̃15% of cancer patients in the U.S. are Black, only 4-6% of clinical trial participants are Black. Only when trial participants reflect the diversity of the general population can oncologists understand how a drug works across subpopulations. The objectives of the BECOME initiative are to understand barriers to trial participation by Black patients with metastatic breast cancer (MBC) and to identify actions to increase participation. Methods: BECOME is sponsored by the Metastatic Breast Cancer Alliance, a consortium of representatives from nonprofit organizations, pharmaceutical/biotech companies, and patient advocates, many of whom are living with MBC. Findings from a literature review and Key Informant interviews informed a survey of U.S. adults living with MBC. Results: Of 424 survey respondents, 102 (24%) self-identified as Black. Black respondents’ trust and satisfaction with their oncology care team were high (&gt; 90%), and 83% of Black respondents were somewhat or very likely to consider trial participation. However, 40% of Black respondents reported no one on their care team had discussed trials. Black respondents’ reasons to not participate in a trial included concerns about side effects (73%) and effectiveness (63%). Black respondents were more likely than non-Black respondents to believe unstudied treatments may be harmful (57% vs 31%). Black respondents were less likely than non-Black respondents to indicate they trust trials (73% vs 91%) and trust that people of all races/ethnicities get fair treatment in trials (32% vs 56%). Black respondents were more likely than non-Black respondents to value receiving trial information from someone with the same racial/ethnic identity (67% vs 10%), who has had breast cancer (73% vs 44%) or MBC (73% vs 51%), or who has been in a trial (72% vs 48%). Black respondents were also more likely to be motivated to participate to ensure people with their racial or ethnic identity will benefit (83% vs 51%). Conclusions: Black patients with MBC are willing to consider participating in clinical trials. Actionable steps to increase Black patient participation include: 1) enhancing awareness about trials by informing patients, increasing education, training healthcare providers to deliver patient-friendly information in an unbiased manner, and providing messaging from people of shared racial/ethnic identity and health experience; 2) building trust through clear communication; 3) addressing concerns about side effects, effectiveness, harm, and fair treatment; and 4) helping patients find and access trials. All stakeholder groups have a role to play in increasing Black patient participation in MBC clinical trials.

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]

Assessing baseline cancer demographics versus those that participate in cancer clinical trials over one year in Louisiana.

e18546 Background: To determine which barriers exist for cancer clinical trial participation in Louisiana and define areas for improvement, we report cancer demographics of all new cancer diagnoses in Louisiana in 2019 and compare those to the baseline demographics of cancer patients that enrolled on a cancer treatment trial. Methods: A retrospective study evaluating baseline cancer demographics over 2019 was performed. Our baseline population included all new cancer diagnoses in patients 18+ registered with the Louisiana Tumor Registry (LTR) between January-December 2019. Baseline demographics were compared between all patients enrolled in a cancer treatment clinical trial in 2019 through the Gulf South Clinical Trials Network (GSCTN) versus those who were not. Summary statistics were performed with regards to basic cancer and patient demographics. Results: Although patients of the highest socioeconomic group made up, n = 5,444, (21.9%) of total cancers, a larger proportion, n = 35 (32.4%), p = 0.01 ultimately enrolled in a trial. Similarly, of those living in an urban area, n = 22,258 (84.5%), a larger proportion, n = 103 (92.8%), enrolled in a trial when compared to those that were not, p = 0.02. There was a significant positive correlation (p = 0.01) between clinical trial enrollment and residency in geographic areas with higher rate of high-school graduation. Our data also demonstrated that a smaller proportion, n = 7 (6.3%), of clinical trial participants died compared to those who did not participate, n = 5176 (19.6%), p &lt; 0.01. Urologic cancer, including both prostate and bladder cancer, was the second most-diagnosed cancer primary site in Louisiana in 2019 with, n = 5481, patients diagnosed. Although black men made up, n = 1767 (32.2%) of diagnosed urologic cancer, only, n = 9 (14.1%), were accrued to participate in a urologic cancer clinical trial, p &lt; 0.01. White men, who made up, n = 3661 (66.8%), of diagnosed urologic cancer, had a larger proportion, n = 55 (85%), of trial participation, p &lt; 0.01. Conclusions: Overall, lack of geographic access proves to be a barrier for recruitment in clinical cancer trials. Patients of higher SES that live in urban areas make up a larger proportion of clinical trial participants and have better survival rates than those who do not participate. For specific cancers such as urologic cancer, further investigation on the cancer-specific inclusion and exclusion criteria must be investigated to determine the effect on equitable trial entry for populations in need. In conclusion, Louisiana offers a diverse cancer population, however, further efforts must be made to improve clinical trial access to our diverse and underserved populations.

Participatory Action for Access to Clinical Trials (PAACT): Increasing participation of blacks in Southeastern Michigan in cancer clinical trails.

e18527 Background: The underrepresentation of minority populations in research violates principles of distributive justice, slows scientific progress, and exacerbates health disparities. Henry Ford Cancer Institute (HFCI) is one of 20 sites offering clinical trials in Michigan and currently participates in 1300 trials. The rate of cancer cases at HFCI is 78% in whites and 21.9% in Blacks/African Americans (B/AA). However, analysis of cancer clinical trials conducted at HFCI showed participation rates to be 2.66% in B/AA and 90.28% in whites. Diverse attempts by HFCI to improve participation of B/AA in clinical trials have yielded limited success. The Participatory Action for Access to Clinical Trials (PAACT) project is using a community-based participatory research (CBPR) approach to design/adapt, pilot, and evaluate interventions which address cancer clinical trial participation barriers among B/AA. Methods: PAACT uses a 5-step approach: 1. Establish a steering committee (SC) in partnership with the Detroit Urban Research Center, which has a strong history of implementing CBPR programs in Detroit. 2. Conduct a scoping review to evaluate evidence-based strategies and interventions used to engage B/AA communities in clinical trials. 3. Conduct qualitative and quantitative research with members of B/AA community, cancer survivors/patients, and HFCI providers. 4. Engage stakeholders in the interpretation and translation of data to inform intervention strategies. 5. Pilot the intervention(s) to assess B/AA individuals’ behavioral intentions to enroll and participate in cancer clinical trials, and health care providers’ intentions to engage in change processes. Results: We have conducted 13 SC meetings, co-facilitated by a community, academic and health system partner. The SC has been actively engaged in all aspects of the project. Through the scoping review, we identified five categories of recruitment and retention strategies. We have conducted 13 focus groups with 100 participants, 7 provider interviews, and administered 1 survey to HFCI staff. Data from the focus groups has provided information on respondents’ clinical trial knowledge and systemic, socio-cultural, and economic barriers to trial participation. Data from the provider interviews has provided information on experience with clinical trial recruitment and recommendations for improving participation among B/AA community members. Conclusions: Through CBPR, PAACT actively engages B/AA community members, survivors/patients, healthcare providers, and researchers in the process to develop/adapt, implement, and evaluate strategies to better inform communities and patients about cancer clinical trials. The long-term goal of this project is to implement changes in both the community and the health care system thereby increase levels of participation in clinical trials among B/AA.

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]

Caregiver Perspectives on the Benefits, Burdens, and Moral Distress of Participation in Cancer Clinical Trials.

Caregivers often face critical decisions, burdens, and perceived benefits related to a loved one participating in cancer clinical trial (CCTs). The purpose of this analysis was to better understand caregivers' perceptions on the benefits and burdens of participation in cancer clinical trials. Using a qualitative descriptive design, interviews with 20 caregivers of patient-participants from a larger parent study were conducted. Three major themes emerged. The benefits of research participation focused on enhancing the potential for saving a loved one's life, improving quality of life, and holding altruistic intentions. The burden of research participation emphasized a loved one's suffering as well as physical, emotional, logistical, and financial burden to caregivers. Caregiver moral distress highlighted distressing ethical encounters, such as making decisions on research participation and navigating suboptimal care. Understanding caregiver perceptions is an important step in designing future CCTs that minimize burdens and maximize patient and caregiver health and family-centered care.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

Barriers and enablers to cancer clinical trial participation and initiatives to improve opportunities for rural cancer patients: A scoping review.

Barriers and enablers to cancer clinical trial participation and initiatives to improve opportunities for rural cancer patients: A scoping review.

The psychosocial responses of patients in cancer clinical trials: are they a barrier to participation?

Abstract Introduction: This paper aims to discuss the psychosocial concomitants with involvement in oncology clinical trials, focusing on barriers that can impact upon participation. It will conclude with some recommendations for strategies to address potential psychosocial barriers with the aim of increasing trial participation rates. Materials and methods: A literature search was carried out using CINAHL, PubMed and EMCare databases with the following keywords for filtering: psychological distress, clinical trials, participation and oncology. The final selection of papers that met the inclusion criteria for this review was manually subjected to Critical Appraisal Skills Programme tool for relevance. Results: Thirteen papers were included in the review. The dominant theme within the literature is psychosocial obstacles to oncology clinical trial participation. Five key barriers were identified: anxiety and fear; ethnicity and social background; tensions between scientific objectives and personal motivations to participation; tensions between personal benefits versus altruism; carer perspectives. Conclusions: The key barriers discussed led to the identification of a set of strategies to help mediate conflicting tensions and motivations of trial enrolment with a view to increasing participation rates. Further prospective research garnering primary data investigating both the psychological and psychosocial factors influencing cancer clinical trial participation for patients needs to be undertaken.

Eligibility Criteria Perpetuate Disparities in Enrollment and Participation of Black Patients in Pancreatic Cancer Clinical Trials.

PURPOSEClinical trials determine safety and efficacy of cancer therapeutics and establish standards of care. Minority patient participation in cancer clinical trials is dismal. We aimed to determine the impact of eligibility criteria on disparities in pancreatic ductal adenocarcinoma (PDAC) clinical trial candidacy.METHODSTraditional PDAC trial eligibility criteria were obtained from ClinicalTrials.gov. Patients with PDAC who sought care at Virginia Commonwealth University Health from 2010 to 2019 were included. Clinical data were obtained from billing codes and discrete values in the electronic medical record. Eligibility criteria differences between racial groups were determined using chi-squared tests and unconditional maximum likelihood-based odds ratios.RESULTSAmong 676 patients, most identified as Black or White race (42.5% and 51.6%, respectively). Using traditional criteria, Black patients were more likely to be ineligible for participation compared with White patients (42.4% v 33.2%, P = .023) secondary to hypoalbuminemia (14.1% v 7.9%, P = .023), HIV (3.1% v 0.3%, P = .010), hepatitis B (1.7% v 0%, P = .043), and hepatitis C (9.1% v 3.4%, P = .005). Black patients were also numerically more likely to be ineligible because of renal dysfunction, recent coronary stenting, and uncontrolled diabetes mellitus. Prior cancer treatment excluded fewer Black than White patients (9.1% v 14.0%, P = .072), most attributable to lower rates of neoadjuvant chemotherapy received. Strategic eligibility criteria revisions could equalize ineligibility rates between Black and White patients (26.8% v 24.8%, P = .581).CONCLUSIONTraditional eligibility criteria differentially exclude Black patients from participating in PDAC clinical trials. These criteria perpetuate disparities, limit generalizability, and are often not medically justifiable. Revised criteria may improve participant diversity, without compromising safety or study results.

Validation of a Population-Based Data Source to Examine National Cancer Clinical Trial Participation

The Centers for Medicare & Medicaid Services requires health care organizations to report the National Clinical Trial (NCT) identifier on claims for items and services related to clinical trials that qualify for coverage. This same NCT identifier is used to identify clinical trials in the ClinicalTrials.gov registry. If linked, this information could facilitate population-based analyses of clinical trial participation and outcomes. To evaluate the validity of a linkage between fee-for-service (FFS) Medicare claims and ClinicalTrials.gov through the NCT identifier for patients with cancer enrolled in clinical trials. This cohort study included 2 complementary retrospective analyses for a validation assessment. First, billing data from 3 health care institutions were used to estimate the missingness of the NCT identifier in claims by calculating the proportion of known participants in cancer clinical trials with no NCT identifier on any submitted Medicare claims. Second, the Surveillance Epidemiology and End Results-Medicare data set, which includes a subset of all FFS Medicare beneficiaries for whom health insurance claims are linked with cancer registry data, was used to identify adult patients diagnosed with cancer between 2006 and 2015 with an NCT identifier in claims corresponding to an interventional cancer clinical trial. To estimate the accuracy of the NCT identifier when present, the proportion of NCT identifiers that corresponded to trials that were aligned with the patients' known primary or secondary diagnoses was calculated. Data were analyzed from March 2020 to March 2021. An NCT identifier present in Medicare claims. The main outcome was participating in a clinical trial relevant to patient's cancer diagnosis. A total of 1 171 816 patients were included in analyses. Across the 3 participating institutions, there were 5061 Medicare patients enrolled in a clinical trial, including 3797 patients (75.0%) with an NCT identifier on at least 1 billing claim that matched the clinical trial on which the patient was participating. Among 1 171 816 SEER-Medicare patients, 29 138 patients (2.5%) had at least 1 claim with a value entered in the NCT identifier field corresponding to 32 950 unique patient-NCT identifier pairs. There were 26 694 pairs (81.0%) with an NCT identifier corresponding to a clinical trial registered in ClinicalTrials.gov, of which 10 170 pairs (38.1%) were interventional cancer clinical trials. Among these, 9805 pairs (96.4%) were considered appropriate. In this cohort study, this data linkage provided a novel data source to study clinical trial enrollment patterns among Medicare patients with cancer on a population level. The presence of the NCT identifiers in claims for Medicare patients participating in clinical trials is likely to improve over time with increasing adherence with the Centers for Medicare & Medicaid Services mandate.

Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019

BackgroundHistorically, females have been underrepresented in clinical trials evaluating the safety and efficacy of investigational drugs and devices. We assessed participation by sex in recent clinical trials. MethodsWe extracted data over a 4-year period (2016–2019) from ClinicalTrials.gov on US-based, pharmaceutical industry or government-funded Phase 1–3 clinical trials of drugs and devices. We included trials with adult cardiovascular, psychiatric, and cancer endpoints whose protocol planned to enroll both sexes. Average proportions of females enrolled per trial were described overall and by disease area. ResultsAcross 1433 trials including 302,664 participants in our analysis, on average, 41.2% were female. Females were underrepresented compared with their proportion of the disease population in cardiovascular disease trials (41.9% female participants vs. 49% female population with cardiovascular disease). In psychiatry, where females comprise 60% of patients, the mean participation of females in clinical trials was 42.0%. Similarly, for cancer trials, where 51% of patients are female, only 41.0% of cancer clinical trial participants were female. For each therapeutic area analyzed, the participation of females in clinical trials fell short of the benchmark derived from national prevalence data. ConclusionsWhile the participation of females in clinical trials has improved compared to previous reports, sex-based gaps still persist between trial populations and those expected to use these drugs/devices based on distributions of diseases in the population. Given potential sex-based differences in treatment responses and toxicities, adequate inclusion of females in clinical trials remains critical.

Implementation of a Multisite Financial Reimbursement Program in Cancer Clinical Trials Integrated With Patient Navigation: A Pilot Randomized Clinical Trial.

PURPOSE:Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment.METHODS:Study participants for this study were recruited at two National Cancer Institute–designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials.RESULTS:The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%).CONCLUSION:The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.