Participation In Cancer Clinical Trials Research Articles

Enhancing Understanding and Engagement: Investigating the Impact of Education on Cancer Clinical Trial Participation

Enhancing Understanding and Engagement: Investigating the Impact of Education on Cancer Clinical Trial Participation

National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC). The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled. The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies. In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.

Understanding the financial cost of cancer clinical trial participation.

Though financial hardship is a well-documented adverse effect of standard-of-care cancer treatment, little is known about out-of-pocket costs and their impact on patients participating in cancer clinical trials. This study explored the financial effects of cancer clinical trial participation. This cross-sectional analysis used survey data collected in December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a nonprofit organization providing social needs navigation and financial assistance to US adults with a chronic illness. Surveys included questions on cancer clinical trial participation, trial-related financial hardship, and sociodemographic data. Descriptive and bivariate analyses were conducted using Cramer's V to estimate the in-sample magnitude of association. Associations between trial-related financial hardship and sociodemographics were estimated using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors. Of 650 survey respondents, 18% (N = 118) reported ever participating in a cancer clinical trial. Of those, 47% (n = 55) reported financial hardship as a result of their trial participation. Respondents reporting trial-related financial hardship were more often unemployed or disabled (58% vs. 43%; V = 0.15), Medicare enrolled (53% vs. 40%; V = 0.15), and traveled >1 h to their cancer provider (45% vs. 17%; V = 0.33) compared to respondents reporting no hardship. Respondents who experienced trial-related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling >1 h vs. ≤30 min to their cancer provider had a 2.2× higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR = 2.2, 95% CI 1.3-3.8). Most respondents (53%) reported needing $200-$1000 per month to compensate for trial-related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a cancer clinical trial (n = 532), 13% declined participation due to cost. Cancer clinical trial-related financial hardship, most often stemming from travel expenses, affected almost half of trial-enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation.

Abstract 4825: Addressing financial toxicity in cancer clinical trial participation: Barriers and facilitators of enrolling in a reimbursement program for out-of-pocket travel costs

Abstract Financial toxicity has been associated with adverse outcomes for patients with cancer. Out-of-pocket (OOP) costs contribute to the high financial toxicity (FT) experienced by patients with cancer. Cancer clinical trial (CCT) participants face significant extra OOP expenses presenting a barrier to participation and retention. To address FT in CCTs, the Lazarex Foundation created the Improving Patient Access to Cancer Clinical Trials (IMPACT) Program, a financial reimbursement program (FRP) for OOP travel and lodging costs associated with therapeutic CCT participation. Our study aimed to quantify the FT experienced by patients in CCTs and understand their experience to determine the barriers and facilitators of enrolling in the Lazarex IMPACT Program. Patients enrolled in a CCT were referred to the IMPACT team to determine eligibility. Patients were eligible for IMPACT if they were active on a therapeutic CCT and their household income was less than 700% of the most recent HHS federal poverty guidelines. Patients who enrolled in the program were invited to participate in a brief semi-structured interview via telephone call. We used grounded theory techniques of analysis to identify themes of barriers and facilitators to enrollment in the Lazarex IMPACT program at our cancer center. Table 1 shows the emerging themes from the interviews as barriers and facilitators of enrolling in IMPACT. As a part of the interview process, patients also completed the COST-FACIT questionnaire, a patent reported outcomes measure to evaluate the degree of FT associated with cancer. COST scores in our cohort (n=39) ranged from 14-39.6, mean=27.12, median=27.5; SD=7.96. Following enrollment in the program, patients on average had COST scores indicating low degrees of financial distress. Taken altogether, our results have the potential to inform the development of FRPs for patients with cancer to facilitate their participation in CCTs. Table 1. Emerging themes from grounded analysis of semi-structured interviews and their frequency Barrier to enrolling in FRP program. No. of Participants Facilitator of enrolling in FRP program No. of Participants Patients wanted to be made aware of program earlier in their CCT timeline 4 Enrollment process was easy and straightforward 17 Patients made aware of program after their CCT started 3 IMPACT team contacted patients to offer program 13 CCT Team unaware of program availability 3 Patients learned about the program through their CCT team 8 Patients reported difficulty with technology access and literacy 3 Patients reported sufficient technology access and literacy 4 Patients reported hesitancy sharing financial information 2 Cancer foundation was timely and helpful in enrollment process 2 Patients reported difficulty navigating vast resources at cancer center 1 Cancer Center social workers provided connection to program 1 Citation Format: Elizabeth Ramos, Vivian Nguyen, Ashley Santaniello, Dana Dornsife, Robert G. Johnson, Paul E. Wileyto, Robert H. Vonderheide, Carmen E. Guerra. Addressing financial toxicity in cancer clinical trial participation: Barriers and facilitators of enrolling in a reimbursement program for out-of-pocket travel costs [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4825.

Shifting from Equality toward Equity: Addressing Disparities in Research Participation for Clinical Cancer Research.

AbstractThere is societal consensus that cancer clinical trial participation is unjust because some sociodemographic groups have been systematically underrepresented. Despite this, neither a definition nor an ethical explication for the justice norm of equity has been clearly articulated in this setting, leading to confusion over its application and goals. Herein we define equity as acknowledging sociodemographic circumstances and apportioning resource and opportunity allocation to eliminate disparities in outcomes, and we explore the issues and tensions this norm generates through practical examples. We assess how equality-based enrollment structures in clinical cancer research have perpetuated historical disparities and what equity-based alternatives are necessary to achieve representativeness and an expansive conception of participatory justice in clinical cancer research. This framework addresses the breadth from normative to applied by defining the justice norm of equity and translating it into practical strategies for addressing participation disparities in clinical cancer research.

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

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

Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials

ObjectiveTo describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. MethodsGynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. Results2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013–2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years – REMGs made up 19.6% of trial participants in 2007–2009 compared to 38.1% in 2016–2018 (p < 0.0001). ConclusionLess than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

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

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

An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants

ObjectivesA lack of diversity amongst participants in cancer clinical trials has raised scrutiny over the past decade. Patients with limited English proficiency (LEP) are further excluded. One modifiable reason for low LEP participation is a lack of non-English consent forms. MethodsWe queried the clinical trials registry database at an academic hospital serving a predominantly Spanish-speaking patient population. Clinical trials related to gynecology oncology were evaluated for the availability of fully translated Spanish consent forms, the racial and ethnic identification of enrolled patients, and the number of signed Spanish consents. Enrolment data was compared before and after 2019, when institutional financial support for document translation was withdrawn. ResultsSixteen gynecologic oncology clinical trials were opened between 2014 and 2022, with 10 trials enrolling 128 patients. Eight trials opened prior to 2019, all with fully translated consent forms. Seven of these trials enrolled 99 participants, 70% of whom identified as Hispanic and 60% who signed a Spanish consent. Eight trials opened after 2019 and one had a fully translated consent form. Three of the trials enrolled 29 participants, with 10% of subjects identifying as Hispanic and none signing a Spanish consent form. ConclusionsThere was a decrease in fully translated clinical trial consent forms for gynecologic oncology studies following the loss of subsidized translation services in our single institution with a predominantly LEP population. This correlated with a decrease in enrollment of Hispanic subjects. To increase enrollment of diverse participants, including those with LEP, simple actions such as fully translating consent forms would help maintain equity in research conduct and improve clinical outcomes through trial involvement.

Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials.

Recruitment of cancer clinical trial (CCT) participants, especially participants representing the diversity of the US population, is necessary to create successful medications and a continual challenge. These challenges are amplified in Phase I cancer trials that focus on evaluating the safety of new treatments and are the gateway to treatment development. In preparation for recruitment to a Phase I recurrent head and neck cancer (HNC) trial, we assessed perceived barriers to participation or referral and suggestions for recruitment among people with HNC and community physicians (oncologist, otolaryngologistor surgeon). Between December 2020 and February 2022, we conducted a qualitative needs assessment via semistructured interviews with a race and ethnicity-stratified sample of people with HNC (n = 30: 12 non-Hispanic White, 9 non-Hispanic African American, 8 Hispanicand 1 non-Hispanic Pacific Islander) and community physicians (n = 16) within the University of Florida Health Cancer Center catchment area. Interviews were analyzed using a qualitative content analysis approach to describe perspectives and identify relevant themes. People with HNC reported thematic barriers included: concerns about side effects, safetyand efficacy; lack of knowledgeand systemic and environmental obstacles. Physicians identified thematic barriers of limited physician knowledge; clinic and physician barriersand structural barriers. People with HNC and physicians recommended themes included: improved patient education, dissemination of trial informationand interpersonal communication between community physicians and CCT staff. The themes identified by people with HNC and community physicians are consistent with research efforts and recommendations on how to increase the participation of people from minoritized populations in CCTs. This community needs assessment provides direction on the selection of strategies to increase CCT participation and referral. This study focused on people with HNC and community physicians' lived experience and their interpretations of how they would consider a future Phase I clinical trial. In addition to our qualitative data reflecting community voices, a community member reviewed the draft interview guide before data collection and both people with HNC and physicians aided interpretation of the findings.

Abstract IA030: Ensuring diversity in clinical trials

Abstract It is well known that minorities, particularly Blacks, are underrepresented in cancer prevention, early detection, and treatment trials. However the mortality rates for Blacks are significantly higher than other race/ethnic groups.  Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. Being able to identify and resolve social determinants of health is essential for clinical trial participation.   It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Utilizing embedded community academic sites to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials is warranted.  Considerable attention has focused on the need to increase underserved racial and ethnic populations in clinical research, especially in light of the cancer health disparities that disproportionately plague these groups.   Clinical trial design and implementation are time-consuming and require a multistep process that is complicated by other factors, including eligibility criteria for clinical trials for underserved racial and ethnic populations, recruitment processes, and patients’ misconceptions or lack of information about clinical trials. Georgetown-Lombardi National Capital Area Minority/Underserved NCORP (NCI Community Oncology Research Program) coupled with the Ralph Lauren Center for Cancer Prevention will reveal strategies and approaches instrumental to our success.  These efforts resulted in the development of a strong community capacity–building and clinical research cancer recruitment strategy, and  improved engagement of the community in clinical research, thus ensuring diversity in clinical trials.   Citation Format: Lucile Adams-Campbell. Ensuring diversity in clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr IA030.

Abstract A011: Evaluation of a theory-informed video intervention to educate underrepresented groups on clinical and genomic research using the Theoretical Framework of Acceptability

Abstract Introduction: Emerging evidence supports the potential effectiveness of technologically based interventions to disseminate health information to underserved populations. Considering the multifactorial barriers to clinical trial and genomic testing participation especially for African Americans (AA), who have been shown to make up less than 10% of all cancer clinical trial participants, a video was developed to inform minority populations on the importance of diversity in clinical trials and genomic research. To confirm that the video was deemed acceptable by the target audience, a quantitative assessment was conducted. Methods: We utilized the Theoretical Framework of Acceptability to create a survey aimed at assessing the animated video. Participants viewed the video and were asked to fill out the survey. Thirty-seven surveys were completed which included members of a patient advisory council at a local hospital (n=6) and graduate students from a medical school (n=29). Results: Responses were recorded on a five-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Participants agreed that they enjoyed viewing the illustrations in the video (𝑋̅=4.32, s=0.97) and listening to the audio (𝑋̅=4.22, s=1.03). After watching the video, participants reported that it educated them on what a “genome” is (𝑋̅=4.16, s=0.83), as well as the benefits of participating in a clinical trial (𝑋̅=4.62, s=0.49) and donating biospecimens (𝑋̅=4.14, s=0.95). Participants moderately agreed that the video informed them on the disadvantages of participation in a clinical trial (𝑋̅=3.38 s=1.36) and biospecimen donation (𝑋̅=3.70, s=1.10). Participants reported feeling confident in making well-informed decisions about participating in clinical trials (𝑋̅=4.27, s=0.69) or donating biospecimens after watching the video (𝑋̅=4.24, s=0.80). However, after watching the video participants reported being somewhat unclear on how to sign up for a clinical trial (𝑋̅=3.57, s=1.21) and how to donate biospecimens (𝑋̅=3.43, s=1.21). Overall, the video was inclusive of the participants’ beliefs and values (𝑋̅=4.24, s=0.76) and attitudes towards the video were favorable with a mean score of 4.4 (s=0.62) on a scale from 1 (Completely Unacceptable) to 5 (Completely Acceptable). Discussion: The feedback received through the TFA adapted questionnaire will be utilized to improve the content of the video. Health communication methods should consider creating technologically based interventions that are deemed acceptable by target populations, in order to engage with and educate underrepresented populations. Citation Format: Victoria Churchill, Jamirah Y. Chevrin, Roland Matthews, Brian Rivers. Evaluation of a theory-informed video intervention to educate underrepresented groups on clinical and genomic research using the Theoretical Framework of Acceptability [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A011.

Abstract A053: Development and evaluation of a community-informed intervention to improve clinical trial knowledge and interest: Preliminary findings

Abstract Introduction: Nationally, racial and ethnic disparities in cancer clinical trial participation exist. Black Americans are underrepresented in cancer clinical trials, with approximately 9% of clinical trial participants in studies sponsored by the National Cancer Institute (NCI) identifying as Black. As part of work supported by the NCI’s National Outreach Network, we adapted educational materials provided by the Center to Reduce Cancer Health Disparities (CRCHD) for dissemination across KCI’s catchment area. Our study aimed to increase knowledge and interest in clinical trials with a focus on concerns salient among Black Americans. Methods: We adapted a CRCHD educational PowerPoint presentation to create Project FACCTs: Facts about Cancer Clinical Trials, a multicultural online video intervention. Adaptation included input from our cancer center’s longstanding Black American community stakeholders and collaborators.  who shared a preference for video format versus PowerPoint presentation and recommended inclusion of a discussion of medical mistrust as well as information on clinical trial costs. Participants were recruited through KCI clinics and community partners. Assessments, provided by the CRCHD, included an 11-item measure of clinical trial knowledge (true/false) as well as 6-item measure of clinical trials interest and attitudes, including likelihood of future participation in a trial (strongly disagree to strongly agree).  Assessments were administered as pre- and post-tests. Results: The majority of our 307 participants identified as Black American (59.3%), female (76.9%), college graduates (63.5%), and had health insurance from a former or current employer (49.8%). Overall, clinical trial knowledge was relatively high at both pre-test (mean=86.7% correct) and post-test (mean=87% correct) across the entire sample. A repeated measures ANOVA revealed a statistically significant difference between Black and White participants on clinical trial knowledge from pre-test (Black: 84.5%; White: 94%) to post-test (Black: 85.4%; White: 93%) (F(1,2) =20.6, p=.01). Across the entire sample, a paired samples t-test showed that clinical trial interest increased after viewing Project FACCTs, (t (297)=-8.84, p=.01). A repeated measures ANOVA demonstrated that within groups there was statistically significant improvement in interest and attitudes towards participating in a clinical trial (F(1, 295) = 34.8 p=.01). Between groups, White participants had a higher overall score in clinical trial interest compared to Black participants (F(1, 2) =9.13, p=.01).  Conclusions: Project FACCTs shows promise as a tool that can improve community members' knowledge, awareness, and interest in clinical trials. One limitation of the work reported here is that participants already had high clinical trials knowledge so the intervention’s effect on those with low knowledge is an area for future inquiry.    Citation Format: Ariel Washington, Brittany Dowe, Rochelle Chapman, Maida Herrera, Madison Pavliscak, Bertram Marks, Hayley Thompson. Development and evaluation of a community-informed intervention to improve clinical trial knowledge and interest: Preliminary findings [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A053.

Abstract B118: Racial and ethnic minorities remain underrepresented in cancer clinical trials despite local cancer incidence

Abstract Introduction: Over the last two decades, racial and ethnic minorities have been underrepresented in cancer clinical trials. Some have suggested that location is a barrier to inclusion in cancer clinical trials. The aim of this project is to assess how diversity of cancer clinical trials reflect their surrounding communities. Methods: Cancer clinical trials for the top five most deadly cancers including lung, breast, prostate, colon and pancreatic were selected from ClinicalTrials.gov. Trials were excluded if they were conducted outside the US or in multiple NIH-designated health service areas (HSA). Location-specific enrollment fractions were determined by comparing the proportion of trial participants to the local cancer incidence. National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) state cancer profiles (statecancerprofiles.cancer.gov) were used to determine HSA-specific data of cancer incidence by race and ethnicity. Results: 904 cancer clinical trials were identified from 2008-2022, including lung (n=157), breast (n= 330), prostate (n=219), colon (n=111) and pancreas (n=87). Overall, reporting of race and ethnicity was poor with only 53.6% of total trials reporting race and 35.9% reporting ethnicity. Compared to the local cancer incidence surrounding trial centers, White patients were overrepresented (p&amp;lt;0.0001), whereas Black (p&amp;lt;0.0001), Asian/Pacific Islander (p&amp;lt;0.0001), American Indian/Alaskan (p&amp;lt;0.0001) and Hispanic (p=0.004) were underrepresented. Furthermore, Black patients were underrepresented across breast (p=0.009), prostate (p&amp;lt;0.0001), lung (p&amp;lt;0.0001), colon (p=0.027) and pancreas (p&amp;lt;0.0001) cancer clinical trials when compared to the local cancer incidence. Conclusion: Racial and ethnic minority patients remain underrepresented in cancer clinical trials when compared to local cancer incidence. These findings reaffirm that location is not the only barrier to cancer clinical trial participation. Further efforts are needed to reduce healthcare disparities and improve patient care. Citation Format: Kelly M. Herremans, Andrea N. Riner, Vignesh Vudatha, Devon C. Freudenberger, Jose G. Trevino. Racial and ethnic minorities remain underrepresented in cancer clinical trials despite local cancer incidence [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B118.

The financial cost of cancer clinical trial participation.

96 Background: Though financial hardship is a well-documented adverse effect of standard-of-care cancer treatment, little is known about out-of-pocket costs and their impact on patients participating in cancer clinical trials. This study explored financial effects of clinical trial participation. Methods: This cross-sectional analysis used survey data collected December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a non-profit organization providing social needs navigation and financial assistance to individuals with a chronic illness. Surveys included questions on cancer clinical trial participation, trial-related financial hardship, and sociodemographic data. Descriptive and bivariate analysis were conducted using Cramer’s V to estimate in-sample magnitude of association. Multivariable analysis and inference on associations between financial hardship and sociodemographics was conducted using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors. Results: Of 650 survey respondents, 18% (N=118) reported ever participating in a clinical trial. Of those, 47% (n=55) reported financial hardship as a result of their trial participation. Respondents reporting trial-related financial hardship were more often unemployed or disabled (58% vs. 43%; V=.15), Medicare enrolled (53% vs. 40%; V=.15), and traveled &gt;1 hour to their cancer provider (45% vs. 17%; V=.33) compared to respondents reporting no hardship. Respondents who experienced trial-related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling &gt;1 hour vs. ≤30 minutes to their cancer provider had 2.2 times higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR=2.2, 95% CI 1.3-3.8). Most respondents (53%) reported needing $200-$1,000 per month to compensate for trial-related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a clinical trial (n=532), 13% declined participation due to cost. Conclusions: Cancer clinical trial-related financial hardship, most often stemming from travel expenses, affects almost half of trial-enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation. These would likely include increased compensation, broader reimbursement for expenses, or changes to trial design that minimize travel and other financial burdens.

Diversity in Cancer Care: Current Challenges and Potential Solutions to Achieving Equity in Clinical Trial Participation.

Access to and participation in cancer clinical trials determine whether such data are applicable, feasible, and generalizable among populations. The lack of inclusion of low-income and marginalized populations limits generalizability of the critical data guiding novel therapeutics and interventions used globally. Such lack of cancer clinical trial equity is troubling, considering that the populations frequently excluded from these trials are those with disproportionately higher cancer morbidity and mortality rates. There is an urgency to increase representation of marginalized populations to ensure that effective treatments are developed and equitably applied. Efforts to ameliorate these clinical trial inclusion disparities are met with a slew of multifactorial and multilevel challenges. We aim to review these challenges at the patient, clinician, system, and policy levels. We also highlight and propose solutions to inform future efforts to achieve cancer health equity.

Patient-recommended communication strategies to enhance clinical trial participation among Black people with cancer.

106 Background: People racialized as Black and/or African American (AA) represent less than 10% of participants enrolled in therapeutic cancer clinical trials that may improve cancer survival. AAs have higher cancer-related mortality rates but are less likely to be invited to participate in clinical trials compared to their white counterparts. We surveyed Black patients with cancer to assess their clinical trial discussion experiences and to identify opportunities to improve clinical trial participation. Methods: A purposive sample of 100 Black patients from a North Carolina Comprehensive Cancer Center were recruited to complete a survey between November 2021 and January 2023. Survey participants were identified through a clinical data warehouse and had to meet the following eligibility criteria: self-identified Black or AA race, diagnosis of either multiple myeloma, breast, prostate, colon, or lung cancer, and actively receiving or undergoing follow up cancer care. Surveys were conducted by a research assistant via phone. This analysis focused on those asked to participate in a clinical trial but declined participation. Results: All participants identified as Black or AA race with 2 participants additionally identifying as American Indian. Half of all surveyed participants were asked to participate in a clinical trial. Of those asked, 58% (n=29) declined and nearly half (n=12) indicated specific barriers that influenced their decision to not participate. Barriers included time constraints, distrust, fear of being harmed or being used as a guinea pig, not understanding the purpose of the study, and feeling rushed in their clinical trial decision making. All 29 participants were asked to select how they would prefer to receive clinical trial information and 97% selected speaking with their oncologist, 90% by video, 66% by internet and by a pamphlet or magazine, 52% at church and only 10% from a barber shop or salon. They also suggested simple and clear messaging about clinical trial opportunities, eligibility criteria, time commitment, taking time to discuss clinical trial options, and recruitment materials that can be taken home. Conclusions: Increasing participation in cancer clinical trials among Black patients with cancer necessitates careful discussion and consideration of fear, distrust, and system level barriers that influence the decision or capacity to enroll. Study recruitment should utilize patient centered communication tools that acknowledge the history of research exploitation in Black communities and clearly describe safety and security measures used in clinical trials.

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

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

Understanding factors associated with breast cancer clinical trial participation.

95 Background: Although cancer clinical trials offer novel treatments which advance cancer care, participating patients do not represent real-world populations. It is unclear how patient sociodemographics, attitudes, and knowledge about clinical trials may influence patient’s participation in breast cancer (BC) clinical trials. Methods: This cross-sectional analysis used survey data collected in December 2022 by Patient Advocate Foundation (PAF), a nationwide non-profit organization providing social needs navigation and financial assistance to individuals with a chronic illness. Women diagnosed with early stage BC within the last five years or metastatic BC at any time and who received PAF services were included. Respondents reported participation in a BC clinical trial, attitudes towards (Attitudes Toward Cancer Trials Scale; scored 18-126, higher scores indicate more positive attitudes), and knowledge about cancer clinical trials (scores 0-7, higher scores indicate more knowledge about clinical trials). Patient-reported sociodemographic and clinical data included age at diagnosis, race (White, Black, Indigenous, or a Person of Color [BIPOC]), education level (high school or lower, some college, Bachelor’s or higher), annual household income (&lt; or ≥ $50,000), employment status (employed, unemployed/other, retired/disabled), BC stage (early, late). Descriptive and bivariate analyses were conducted using Cramer’s V or Cohen’s d as effect sizes. A hypothesized path model was evaluated with a Structural Equation Model (SEM). Estimated standardized direct, indirect, and total effects of variables of interest on clinical trial participation were evaluated with 0.1, 0.3, and 0.5 indicating weak, medium, and large magnitude, respectively. Results: All 358 respondents were eligible to be included in our analysis. Overall, 39% were BIPOC, 38% had a Bachelor’s degree or higher, 69% had incomes &lt;$50,000, and 49% were retired or disabled. Respondent clinical trial knowledge was low (mean 3.5, standard deviation (SD) 1.9). Respondents who reported trial participation (15%, n=54) more often had a Bachelor’s degree or higher (50% vs 36%; V 0.12) and more positive attitudes toward trials (mean 88, SD 23.3 vs 83, SD 15.6; d 0.29) compared to those not reporting participation. SEM (RMSEA=.02) revealed that positive attitudes towards, but not knowledge of, cancer clinical trials were associated with prior clinical trial participation (standardized total effect 0.13, p=0.01; 0.04, p=0.47, respectively). Knowledge of clinical trials was associated with positive attitudes toward clinical trials (0.15, p=0.003). No other sociodemographic variable had a statistically significant association with BC clinical trial participation. Conclusions: Future interventions to increase enrollment should focus on promotion of positive attitudes towards clinical trials, potentially through increased trial knowledge.

Timing of receipt of palliative care among participants in early-phase cancer clinical trials.

260 Background: Early phase clinical trials (EP-CTs) investigate novel therapeutics for patients with cancer. EP-CT participants often have advanced stages of disease, have received multiple lines of prior therapies, and remain sufficiently functional to enroll on EP-CTs. Limited research exists to describe the use and timing of palliative care (PC) in EP-CTs. Methods: We conducted a prospective study of patients with cancer enrolled on EP-CTs at Massachusetts General Hospital from April 2021- January 2023. We extracted demographic and clinical characteristics from the electronic health record as well as timing of receipt of PC (before/during EP-CT vs after EP-CT/never) and reason for PC referral documented in the referral. We used patient-reported surveys at time of treatment initiation to assess symptom burden (Edmonton Symptom Assessment System [ESAS]), financial toxicity (Comprehensive Score for Financial Toxicity [COST], lower scores indicate greater toxicity), quality of life (QOL; Functional Assessment of Cancer Therapy-General [FACT-G]), and hope (Herth Hope Index [HHI], higher scores indicate greater hope). We used descriptive statistics to explore associations of timing of receipt of PC with patient characteristics, symptom burden, financial wellbeing, QOL, and hope. Results: Of 221 eligible patients, we enrolled 204 (enrollment rate 92.3%, median age=63.4 years [range 54.8-70.2]; 57.0% female, 94.1% metastatic cancer). Less than one third of patients received PC before/during EP-CT (31.8% before/during, 68.2% post/never). Reasons for referral include: symptom management (84.4%), coping (12.5%), advance care planning (7.8%), illness understanding (1.6%), and treatment decision-making (1.6%). Patients age &lt;65 were more likely than those 65+ to receive PC before/during EP-CT (39.1% vs 22.1%, p=0.01). Patients with ECOG=1 were more likely than those with ECOG=0 to receive PC before/during EP-CT enrollment than post enrollment/never (37.9% vs 22.9%, p=0.01). Patients who received PC before/during EP-CT had a higher symptom burden (ESAS: 20.7 vs 15.5, p=0.01), lower QOL (70.9 vs 77.0, p=0.003), and worse financial toxicity (25.2 vs 29.4, p=0.003). We found no significant differences in hope scores based on timing of receipt of PC (27.6 vs 27.1, p=0.53). Conclusions: In this prospective cohort of EP-CT participants with cancer,less than one third received PC before/during EP-CT enrollment. Symptom management was the most common reason for referral to PC, which aligns with our patient-reported survey data. Characteristics associated with receiving PC before/during trial participation include age, decreased performance status, higher symptom burden, lower QOL, and increased financial toxicity. These findings suggest that earlier PC was appropriately delivered to those most in need yet highlight the importance of efforts to ensure earlier integration of PC in this population.