Participation In Cancer Clinical Trials Research Articles

Association of Community-Level Social Vulnerability With Clinical Trial Discussion and Participation Among Cancer Survivors.

Community factors and structural barriers may contribute to disparities and underrepresentation in cancer clinical trials. We evaluate the influence of community-level social determinants of health, as measured by the Centers for Disease Control and Prevention Social Vulnerability Index (SVI), on disparities in cancer clinical trial discussion and participation. We performed a cross-sectional analysis of the 2021 Health Information National Trends Survey-SEER, a representative survey of cancer survivors sampled from three SEER registries. The primary outcomes included patient-reported clinical trial discussion and participation. The primary exposure was county-level SVI, linked to each survey respondent by ZIP code of residence and categorized into quintiles. Survey-weighted bivariate comparisons and multivariable logistic regression were performed to evaluate the association between SVI and clinical trial discussion and participation, adjusting for age, sex, race and ethnicity, education, income, and cancer stage. We identified 1,220 respondents residing in 153 counties with a median SVI of 0.41 (IQR, 0.27-0.62), representing a population of over 400,000 cancer survivors on weighted analysis. Of the cohort, 15.1% reported clinical trial discussion and 7.7% reported clinical trial participation. Patients who are most socially vulnerable (fifth quintile of SVI) had significantly lower odds of clinical trial discussion (odds ratio [OR], 0.36 [95% CI, 0.15 to 0.87]; P = .02) and clinical trial participation (OR, 0.15 [95% CI, 0.03 to 0.75]; P = .02) compared with patients who are least socially vulnerable (first quintile of SVI). These findings suggest interventions to identify socially vulnerable communities for expansion of clinical trial opportunities and infrastructure may be an impactful strategy toward improving diversity and representation in cancer clinical trials.

Perspectives on Neoadjuvant Clinical Trial Participation for Patients with Kidney Cancer: A Survey-Based Examination

Background: Kidney cancer is amongst the deadliest genitourinary malignancies. Neoadjuvant systemic therapy has the potential to improve survival and overall outcomes in select patients. Enrolling patients in trials of neoadjuvant treatment for kidney cancer is challenging, which limits neoadjuvant treatment development. Objective: This study aims to develop a better understanding of the barriers patients face in kidney cancer clinical trial participation, with a particular focus on neoadjuvant trials for renal cell carcinoma. Methods: From 2022–2023, we recruited participants with a history of kidney cancer through a Qualtrics survey that was sent to the Kidney Cancer Association (KCA) and Kidney Cancer Cure (KCCure) mailing lists and social media pages. Patient responses on demographics, clinical information, and perspectives were evaluated. Results: Ninety-four individuals completed the survey. Eighty-one percent of respondents reported not participating in clinical trials due to not being informed about potential applicable trials. Importantly, many (76%) respondents reported that prevention of cancer return was a highly important reason to participate in clinical trials. Most respondents reported a willingness to undergo a kidney biopsy (59%), and/or additional appointments (58%) and surgery delays. Conclusions: Increased patient awareness about clinical trials with the potential to delay cancer recurrence may increase patient participation in clinical trials. Clinical trial design, including additional appointments or interventions and/or minor surgery delays are not major barriers to trial participation.

Breast cancer clinical trial participation among diverse patients at a comprehensive cancer center

This study was designed to determine the enrollment patterns in breast cancer clinical trials (CCTs) of patients with diverse backgrounds in an equal access setting and to evaluate the factors contributing to low rates of clinical trial accrual in patients of low socioeconomic status (SES). We performed a retrospective review of a prospectively maintained database of new patients seen at the Dan L. Duncan Comprehensive Cancer Center dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCTs. We compared the rate of CCT availability, eligibility, and enrollment between two patient populations: Smith Clinic, where most patients are of low SES and uninsured, and Baylor St. Luke’s Medical Center (BSLMC) with mostly predominantly insured, higher income patients. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the differences in CCT enrollment. More patients were eligible for CCTs at Smith Clinic (53.7% vs 44.7%, p < 0.001). However, Smith Clinic patients were more likely to decline CCT enrollment compared to BSLMC (61.3% declined vs 39.4%, p < 0.001). On multivariate analysis, Black patients had a significantly higher rate of CCT refusal overall (OR = 0.26, 95% CI 0.12–0.56, p < 0.001) and BSLMC only (OR = 0.20, 95% CI 0.060–0.60, p = 0.006). Our data shows that it is likely an oversimplification to assume that equal access will lead to the elimination of CCT disparities. Efforts to diversify CCTs must include consideration of structural and institutional inequities as well as social needs.

Improving Access to Patient-Focused, Decentralized Clinical Trials Requires Streamlined Regulatory Requirements: An ASCO Research Statement.

Strategies to bring clinical trials closer to patients gained momentum during the COVID-19 pandemic, enabling more participants to receive treatment and/or testing in their local communities. Incorporation of decentralized trial elements presents both opportunities and challenges, spanning regulatory, technical, and operational aspects. This ASCO research statement includes timely consensus-driven recommendations and a call for engagement of all research stakeholders. ASCO held multistakeholder meetings with leaders in oncology research and concluded that research-related regulatory and administrative requirements and burdens present critical barriers to decentralizing trials. One example is sponsor and contract research organization (CRO) use of US Food and Drug Administration (FDA)'s Statement of Investigator (Form 1572), which was found to exceed FDA's stated intent and used in conservative ways disproportionate to potential risks to participants and scientific integrity. As a result, research sites experience an avalanche of downstream administrative and regulatory activities that consume considerable resources. This statement recommends four key solutions to address such barriers and recalibrate regulatory and administrative expectations for decentralizing trials: (1) FDA should engage the research community in a public-private partnership to modernize standards and enable local access to trials; (2) sponsors and CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency; (3) research centers, networks, and sites should update policies and procedures to implement decentralized trial elements; and (4) research community should develop a streamlined, uniform mechanism to simplify regulatory data collection and documentation and use it consistently across trials. We can and must prioritize a concerted commitment to simplify and streamline regulatory requirements and practices to broaden access to and participation in cancer clinical trials.

Disparities in cancer clinical trials information-seeking: Findings from the National Cancer Institute’s Cancer Information Service

ObjectiveTo better understand cancer clinical trials (CCT) information-seeking, a necessary precursor to patient and provider engagement with CCT. MethodsData from the National Cancer Institute’s Cancer Information Service (CIS) were used to examine CCT information-seeking patterns over a 5-year period. Descriptive and logistic regression analyses were conducted to examine characteristics of CIS inquiries and their associations with having a CCT discussion. ResultsBetween September 2018 – August 2023, 117,016 CIS inquiries originated from cancer survivors, caregivers, health professionals, and the general public; 27.5 % of these inquiries included a CCT discussion (n = 32,160). Among CCT discussions, 35.5 % originated from survivors, 53.5 % from caregivers, 6.1 % from the public, and 4.9 % from health professionals. Inquiries in Spanish had lower odds of a CCT discussion (OR=.26, [.25–.28]), whereas inquiries emanating from the CIS instant messaging (OR=2.29, [2.22–2.37]) and email (OR=1.24, [1.18–1.30]) platforms were associated with higher odds of discussing CCT compared to the telephone. Individuals who were male, younger, insured, and had higher income and education had significantly higher odds of a CCT discussion while those who were non-Hispanic Black and living in rural locales had significantly lower odds. ConclusionsDisparities in CCT information-seeking may contribute to downstream CCT participation. Practice ImplicationsQuality, language-concordant health information is needed to enable equitable awareness of – and ultimately engagement in – CCT.

Participants’ perceptions support the coexistence of benefits and burdens of cancer clinical trial participation

Background To advance oncology treatment for adults, comprehensive understanding of how and why people decide to enroll in, remain in, and withdraw from cancer clinical trials is needed. While quantitative findings provide insights into these benefits and burdens, they provide limited understanding of how adults with cancer appraise their situation and approach decisions to undertake a clinical trial. The goal of this mixed methods analysis was to conceptualize participants’ assessment of benefits and burdens related to cancer clinical trial participation. Materials and methods This sub-group analysis of 21 participants was part of a larger sequential, explanatory mixed methods study. We used Creamer’s integrated approach to linking quantitative and qualitative data to assess convergence, with qualitative data explaining quantitative results. Participants were grouped into four categories based on quantitative benefit/burden scores and thematic analysis of their qualitative data was used to describe these categories. Results Across groups participants varied in descriptions of benefits and burdens of cancer clinical trial participation and reasons for participating. Those reporting high benefit/low burden described “seizing the opportunity to participate;” those reporting low benefit/low burden described “taking responsibility” through trial participation; those reporting low benefit/high burden described how they were “willing to endure,” and those with high benefit/high burden emphasized “deciding to act.” Conclusions Participants’ qualitative descriptions of benefits and burdens were more nuanced and dynamic than reflected in their quantitative ratings. Thus, current measures may be missing important concepts, such as logistic challenges of trial participation. Our results have implications for consenting procedures and decisional support guidance offered to patients and their caregivers.

Time Toxicity Experienced by Early-Phase Cancer Clinical Trial Participants.

Early-phase clinical trials (EP-CTs) are designed to determine optimal dosing, tolerability, and preliminary activity of novel cancer therapeutics. Little is known about the time that patients spend interacting with the health care system (eg, time toxicity) while participating in these studies. We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 to obtain baseline characteristics and number of health care-associated days, defined as all inpatient and outpatient visits while on trial. We used univariable and multivariable analyses to identify predictors of increased time toxicity, defined as the proportion of health care-associated days among total days on trial. For ease of interpretation, we created a dichotomous variable, with high time toxicity defined as ≥20% health care-associated days during time on trial and used regression models to evaluate relationships between time toxicity and clinical outcomes. Among 408 EP-CT participants (mean age, 60.5 years [standard deviation, SD, 12.6]; 56.5% female; 88.2% White; 96.0% non-Hispanic), patients had an average of 22.5% health care-associated days while on trial (SD, 13.8%). Those with GI (B = 0.07; P = .002), head/neck (B = 0.09; P = .004), and breast (B = 0.06; P = .015) cancers and those with worse performance status (B = 0.04; P = .017) and those receiving targeted therapies (B = 0.04; P = .014) experienced higher time toxicity. High time toxicity was associated with decreased disease response rates (odds ratio, 0.07; P < .001), progression-free survival (hazard ratio [HR], 2.10; P < .001), and overall survival (HR, 2.16; P < .001). In this cohort of EP-CT participants, patients spent more than one-fifth of days on trial with health care contact. We identified characteristics associated with higher time toxicity and found that high toxicity correlated with worse clinical outcomes. These data could help inform patient-clinician discussions about EP-CTs, guide future trial design, and identify at-risk patients.

Black/African American participation in cancer clinical trials: A qualitative study of community members, patients with cancer, and survivors (Detroit, MI) using CBPR.

e13743 Background: Black/African Americans (B/AA) have a disproportionate cancer burden and the highest mortality rates of any racial/ethnic group for most cancers. Racial/ethnic variation in cancer burden reflects health inequities, differences in risk factors, heredity and genomic diversity, and lack of access to and participation in cancer prevention, screening, treatment, and clinical trials. Twelve percent of the United States population are B/AA; however, only about 5% B/AA participate in clinical trials. As a result, data regarding tumors from B/AA are not equally represented in new drug discovery efforts. Methods: Participatory Action for Access to Clinical Trials (PAACT) used a Community Based Participatory Research (CBPR) approach to support a partnership between Henry Ford Health (HFH) and eight African American, Caribbean, and continental African community-based organizations (CBOs). Focus group data were collected in-person and virtually with representatives from the CBOs and HFH cancer survivors. CBOs participated in Steering Committee meetings throughout the project and two community forums to obtain feedback on recommendations identified through the qualitative data. Results: Factors contributing to participation in cancer clinical trials included systemic issues related to racism, health disparities and trust in government, health systems, and clinical research. Other factors included personal experiences with healthcare systems, healthcare provider-patient communication, socio-economic barriers (e.g., time away from work, family), and perceptions of future benefits from trials for B/AA communities. Recommendations included: 1) on-going health system outreach to B/AA communities regarding cancer prevention and treatment, as well as clinical trials. 2) B/AA community liaisons and cancer survivors as providers of information related to clinical trials; 3) two-way provider-patient communication to address questions and concerns about treatment options and trial information; 4) monetary compensation for indirect trial costs; 5) information on the importance of diversity within trials; and 6) ensuring information is provided to patients’ support networks. Conclusions: CBPR is effective in the identification of factors that influence participation in clinical trials. Building trust between patients and the healthcare system begins before patients walk into a clinic and every interaction contributes to institutional worthiness of community and patient trust. It is possible and imperative for health systems to work with B/AA communities and jointly identify and implement recommendations to ensure informed decision-making regarding trial participation. We are currently designing intervention strategies based on the recommendations for implementation at HFH.

Systematic review of rural interventions addressing barriers and facilitators in recruitment and adherence of oncology clinical trials.

e13675 Background: Rural patients are significantly underrepresented in cancer clinical trials leading to an inequitable distribution of research funding and excluding rural patients from innovative care. Properly understanding the barriers and facilitators to rural patient participation in cancer clinical trials is essential to lessen this disparity in representation. Methods: EBSCO Medline, Embase, Cinahl, Cochrane and PsycInfo were systematically searched for articles related to the primary research objective. The search strategies focused on a combination of keywords pertaining to “rural populations”, “cancer”, and “clinical trials”. Additional search terms included the presence of “barriers” or “facilitators” within the articles. Articles were removed from the study if they were not written in English, were conducted outside the U.S., focused on pediatric populations, or lacked original data. Results: A systematic review of the literature reveals that barriers and facilitators to cancer clinical trial participation by rural populations are present at the patient, physician, and healthcare system levels. Notable barriers found in this review include the burden of travel, lack of patient knowledge about clinical trial participation, insufficient provider communication and awareness of current trials, and strict eligibility criteria. Promising facilitators include caregiver support, close physician support and contact, and programs to increase patient understanding of clinical trials. Potential future interventions include telemedicine, expanding monetary support for clinical trial transportation, utilizing RUCA codes to document disparities and elucidate further interventions, and cultivating stronger partnerships between industry and rural medical facilities, as well as between the NCI, academic institutions, and rural medical facilities. Conclusions: There is a significant and urgent need to strengthen this body of literature as is underscored by the apparent lack of cancer clinical trials in rural counties, specifically in the state of Texas (CPRIT). It is evident that barriers need to be further elucidated to ascertain why rural patients have less participation in clinical trials, and facilitators need to be further explored in order to sufficiently illustrate and thus effectively harness the power of facilitators in the pursuit of lessening disparities and improving cancer outcomes for rural patients.

Association of patient-reported experience of care with cancer clinical trial participation.

11117 Background: Few individuals diagnosed with cancer participate in clinical trials. Patient-reported experience of care (PEC), assessing patients’ perspectives on interactions with healthcare providers and systems, is important in evaluating quality of care. To help identify patient-centered strategies that may enhance trial enrollment, we examined whether PEC may predict enrollment in clinical trials. Methods: This study utilized Surveillance, Epidemiology, and End Results-Consumer Assessment of Healthcare Providers and Systems (SEER-CAHPS) linked data, including SEER registry data, CAHPS PEC surveys, and Medicare claims. Individuals in SEER-CAHPS who were diagnosed with lung cancer 2000-2018 and completed a CAHPS survey ≥6 months following diagnosis were included. The study outcome, clinical trial enrollment after cancer diagnosis, was determined using Medicare claims; among individuals who enrolled in clinical trials, only those completing a CAHPS survey before trial enrollment were included. PEC was assessed using 5 global ratings (Overall Care, Personal Doctor, Specialist, Health Plan, and Prescription Drug Plan) and 6 composite measures (Doctor Communications, Getting Needed Care, Getting Care Quickly, Getting Needed Drugs, Care Coordination, and Customer Service); all were scored 0 (worse PEC) to 10 (best PEC). Associations of trial participation and PEC were assessed using multivariable logistic regression, controlling for age, race/ethnicity, dual Medicaid status, fee-for-service vs Medicare Advantage plan at diagnosis, and physical problems limiting activities, and were weighted to correspond to the overall SEER population. Results: The study included 5,361 individuals diagnosed with lung cancer; 4.8% of the weighted population enrolled in a clinical trial. Patients with higher PEC ratings for their Specialist (odds ratio [OR] for a 1-point higher PEC score 0.86, 95% CI 0.76, 0.98); for their Health Plan (OR 0.87, 95% CI 0.80, 0.96); and for Getting Needed Care (OR 0.89, 95% CI 0.81, 0.98) had significantly (p&lt;0.05) lower oddsof having enrolled in a clinical trial. Among individuals without physical limitations, association of PEC and trial enrollment were similar. Among individuals with physical limitations, higher PEC ratings for Getting Care Quickly were associated with higher odds (OR 1.20, 95% CI 1.03, 1.39) of having enrolled in a trial. Conclusions: In this population, reporting worse PEC in certain domains was significantly associated with increased clinical trial enrollment. This suggests patients less happy with their clinical care may be more likely to enroll in trials, perhaps to receive different types of care and/or from different providers. PEC associations with trial enrollment differ between patients with vs without physical limitations, suggesting different strategies may be effective for increasing trial enrollment among these two sub-groups.

Cancer clinical trial participation in socioeconomically vulnerable patients: A risk model to aid in targeted interventions.

1529 Background: In patients with cancer, those with lower income are 30% less likely to participate in clinical trials. Lower income individuals face direct and indirect costs that can make participation in a clinical trial prohibitive. However, a broader evaluation of specific behavioral, information, insurance, and area-level variables that could contribute to this disparity has not been conducted. We aimed to develop and validate a model to identify socioeconomically vulnerable patients at high risk of non-participation in clinical trials. Methods: We used data from the Health Information National Trends Survey (HINTS), a national cross-sectional survey about knowledge of, attitudes toward, and use of health-related information. We analyzed HINTS survey databases that included questions about whether patients with cancer participated in a clinical trial (survey years 2014, 2017, and 2020). We examined 21 different demographic, socioeconomic, behavioral, geographic, and health information questions. We derived a risk model to predict clinical trial participation in a random set of 60% of participants using best subset selection with k-fold cross validation. The derived model was validated in the remaining 40% of participants. Logistic regression was used. Results: We examined N=1,023 participants with household income &lt;$75,000, the current median in the U.S. In the training dataset of n=614 participants, a model with 5 variables was identified. Non-Hispanic White patients and patients without a college education, with high levels of distrust, with high levels of anxiety or depression, and from non-urban areas were all at lower risk of trial participation. We summed the adverse risk factors for all individuals; a risk score with 4 levels was constructed based on distribution quartiles. In the independent validation cohort (n=409), each increase in level of adverse risk factors was associated with a 42% reduction in the odds of trial participation (OR=0.58, 95%-CI, 0.40-0.84, p=.004), indicating successful model validation. Among all individuals, trial participation rates decreased from 18.6% to 7.5% to 4.6% to 2.8%, respectively, as the number of adverse risk factors increased (in quartiles) from 0-1 to 2 to 3 to 4-5. Individuals with 4 or 5 risk factors (vs. those with 0-1 factors) were 87% less likely to participate (OR=0.13, 95% CI, 0.05-0.31, p&lt;.0001). Conclusions: We developed and validated a 5-variable risk model that identified a large set of lower income individuals at lower risk of trial participation. In a first-time observation, psychosocial variables were shown to be meaningful predictors of lower trial participation. These findings could aide in the early identification of patients who may benefit from additional support to navigate the treatment trial decision making process, in the name of more equitable participation in trials for all patients.

Educating hematology-oncology fellows about how to communicate with patients about cancer clinical trials: A needs assessment.

9029 Background: Cancer clinical trials (CCTs) are vital to advancing treatment yet only 5-8% of people with cancer ever participate, with even lower rates among underserved groups. Teaching oncologists in training how to communicate about CCTs may improve the frequency and quality of patient-oncologist communication about CCTs and increase participation. However, little is known about interest in or feasibility of such training during Hematology-Oncology (Hem-Onc) graduate medical education (GME) fellowships. We aimed to determine Hem-Onc fellowship programs’: 1) current practices, needs, and preferences for CCT-related communication training; and 2) the acceptability and feasibility of implementing a CCT communication skills workshop. Methods: We recruited and surveyed program directors (PDs) from Hem-Onc fellowship programs across the U.S. PDs were recruited via email through the ASCO program directors’ community, a publicly accessible list of ACGME Hematology-Oncology programs, and co-authors’ professional networks. Participants were compensated with a $50 gift card. Survey data were analyzed using descriptive statistics and responses were measured on a 5-point Likert scale (1 = “strongly disagree” to 5 = “strongly agree”). Results: 40 PDs were surveyed, most representing programs in the Northeast (30%), Midwest (25.6%), Southeast (20.5), and Southwest (15.4%) U.S. Most were male (57%) and identified as White (55%), Asian (30%), Black/African American (2.5%) and Native American/Alaskan Native (2.5%). PDs stated their institutions prioritize CCT accrual (M=4.58, SD=.78) and clinical research training (M=4.20, SD=.85). They reported their GME CCT curriculum least often addressed: (1) How to talk to patients about CCTs when none are available (27.5%), and (2) How to help patients find CCTs at other institutions (17.5%). PDs rated their fellows’ CCT knowledge as lowest in: (1) Provider-level barriers to enrolling/referring patients in CCTs (M=3.41, SD=.91) and (2) System-level barriers to patient accrual to CCTs (M=3.33, SD=.95). Fellows’ lowest-rated CCT communication skills areas were: (1) Making shared decisions with patients about CCT participation (M=3.54, SD=1.14) and (2) Patient-centered communication (M=3.50, SD=1.15). PDs were interested in a CCT communication workshop (‘yes’=67.5%, ‘maybe’=32.5%) and said such training was feasible (M=4.28, SD=.78) and useful (M=4.47, SD=.78). Training preferences were live presentations (M=3.9, SD=1.03) and program-tailored virtual workshops (M=3.9, SD=1.08). Conclusions: Hem-Onc fellowship program leaders expressed a need for training that improves fellows’ CCT knowledge and patient-centered communication skills. By highlighting current practices, challenges, and preferences, this study is an important step towards implementing and scaling communication skills training in GME programs.

Access to and equity in cancer clinical trials in Oregon.

e23100 Background: Approximately 20,000 people per year are diagnosed with cancer in Oregon. The OHSU Knight Cancer Institute is the only academic cancer center in the state, with the nearest center located almost 200 miles away. Clinical trials (CT) are essential for cancer care but only a small proportion of eligible people participate due to multiple factors. In this retrospective study, we identified the association between sociodemographic factors and cancer CT participation at OHSU. Methods: Adult patients referred to OHSU for evaluation and treatment of a new cancer 2019-2022 were included. Data collected included age, gender, race/ethnicity, zipcode, insurance, type of cancer and CT participation. Zip-codes were used to estimate poverty level as defined by the American Community Survey, rural vs. urban location and distance to the cancer center. Multivariate analysis was conducted to identify factors associated with CT participation. Results: A total of 14,261 patients with median age 65 (18-101) years were treated at OHSU from 2019-2022 (86% for solid tumors, 14% hematologic malignancies). Of these, 53% were &gt; 65yrs, 51% male and 8.5% self-identified as non-White (including Hispanic). These numbers are similar to those reported in the statewide cancer registry. About 61% of those &lt; 65 yrs were privately insured, 84% of those &gt; 65 yrs had Medicare, and 31% were from areas at or below the national poverty level. About 40% lived &gt; 30 miles from OHSU (29% &gt; 60 miles, 14% &gt; 120 miles) and 31.5% lived in rural areas. A total of 2134 patients (15%) participated in cancer CT (8% interventional, 6% interventional therapeutic and 10% noninterventional). Factors independently associated with decreased CT participation on multivariate analysis included age &gt; 65yrs regardless of type of insurance, &lt; 65yrs with public insurance, female, racial/ethnic minority, solid tumor diagnosis and cancer care at a community-based clinic (Table 1). Conclusions: Patient with cancer treated at OHSU are representative of the population in our catchment area and region. However, there is room to improve access and CT participation for older adults and persons from racial/ethnic minorities and disadvantaged backgrounds. Our study highlights the importance of understanding the catchment area and accounting for social determinants of health when implementing community outreach strategies for CT participation. [Table: see text]

Disparities in gynecologic oncology clinical trial availability in the United States: A state-level analysis.

e23128 Background: Disparities in minority participation in gynecologic cancer clinical trials is well documented. FDA guidance stipulates geographic informed analyses to reduce barriers to trial participation. We performed a geographical analyses of gynecologic cancer clinical trials in the United States relative to racial distribution and social vulnerability indices to identify areas of increased need. Methods: We performed a cross-sectional analysis of NIH ClinicalTrials.gov by retrieving all trials first posted 1/1/2013 through to 1/10/2024. We searched for ovarian, uterine, cervical, endometrial, vaginal/vulvar and gynecological cancer. We reviewed enrollment criteria to exclude non-gynecological cancers (1643 trials) or non-invasive gynecological conditions (224 trials). We aggregated census data, state-level total population size, percent Non-Hispanic White (NHW), and the FEMA Expected Annual Loss per state as a measure of social vulnerability. Using R statistical software (v 4.3.1), we measured the association between these variables and the number of gynecological trials per 100,000 persons using Pearson’s correlation. Results: We identified 3,428 trials, filtered down to 1,561 invasive cancer trials. The most common trials were ovarian (911, 58.3%) and cervical (438, 28.0%), followed by endometrial (385, 24.6%), uterine (158, 10.1%), vulva-vaginal (78, 4.99%), and 7.62% genetic-based. Texas had the highest number of trials (501) followed by California (454) and New York (427). The state with the highest population-adjusted number of trials was South Dakota (8.57 trials per 100,000 persons), followed by Rhode Island at 8.38 per 100,000 persons. California, Mississippi, and Puerto Rico had the lowest number of trials per 100,000 persons with 1.148, 0.979, 0.466 respectively. States/territories with greater than 4 trials per 100,000 were comprised of populations that were &gt; 50% NHW. The correlation between the state-level percentage of NHW in 2020 and the number of trials per 100,000 persons was p = 0.057 indicating that there was a correlation between Whiteness at the state-level and trial availability. We found that states with higher FEMA expected annual loss had lower numbers of gynecological trials per 100,000 persons (p &lt; 0.001). Conclusions: We found a disparity in the geographical distribution of trials available for gynecological cancers that was correlated with racial disparities and social vulnerability. Efforts to increase decentralization of trials and improve access and availability of gynecologic cancer clinical trials are necessary to increase equity for minority representation in clinical trials at the national level.

Longitudinal changes in patient-reported outcomes (PROs) among early phase cancer clinical trial (EP-CT) participants.

e23188 Background: Little research has explored associations of longitudinal changes in PROs and clinical outcomes among EP-CT participants. We sought to describe changes in PROs over the first month of EP-CT participation and examine associations of changes with clinical outcomes. Methods: We prospectively enrolled adults participating in EP-CTs at Massachusetts General Hospital from 04/2021-01/2023. We assessed quality of life (QOL) (Functional Assessment of Cancer Therapy-General, with subdomains: physical wellbeing [PWB], emotional wellbeing [EWB], social wellbeing [SWB], functional wellbeing [FWB]); hope (Herth Hope Index); symptom burden (Edmonton Symptom Assessment System); and financial wellbeing (Comprehensive Score for Financial Toxicity) at time of EP-CT enrollment and one month later (1-month). We used descriptive statistics and regression models to describe 1-month changes in PROs and explore associations of patient-reported QOL, hope, symptom burden, and financial wellbeing with patient factors (age, diagnosis, performance status) and clinical outcomes (time on trial [TOT], treatment response, ED visits, hospitalizations, and survival). Results: Of 205 enrolled patients, 159 (77.9%) had baseline and 1-month data evaluable for analysis (median age: 63.0 [range 33.0 – 88.6], 59.8% female, 93.6% metastatic cancer, ECOG 0 = 46.2% and ECOG 1 = 53.8%). Most common cancer types were gastrointestinal (31.5%) and breast (22.0%). There was no significant change from baseline to 1-month in mean QOL (75.2 to 76.2), hope (27.1 to 26.7), ESAS total symptom burden (20.4 to 20.9), ESAS physical symptoms (13.3 to 13.7), and financial wellbeing (28.5 to 28.0). There was no significant change in overall QOL and in each subdomain with the exception of EWB (16.2 to 17.0, p &lt; .001). Older age was associated with increased hope (B = 1.29, p = .008) and increased QOL (B = 3.02, p = 0.024). Increasing EWB at 1-month was associated with longer TOT (HR = 0.93, p = .011). Increased symptom burden at 1-month was associated with greater risk of ED visits (HR = 1.04, p = .005) and hospitalizations (HR = 1.03, p = .012). Improving financial wellbeing at 1-month was associated with lower risk of hospitalization (HR = 0.96, p = .046). We found no other significant associations of 1-month changes in PROs with treatment response or survival. Conclusions: We described changes in PROs from baseline to 1-month and identified factors associated with these changes. Despite the rigors and intensity associated with EP-CT initiation, most PROs did not worsen, with significantly improved EWB after 1-month of participation. Results demonstrate changes in physical symptoms predicted for greater risk of ED visits and hospitalizations. Future studies should build upon this work and measure PROs throughout trial participation to identify factors associated with changes and guide intervention development.

Change in financial toxicity during early-phase cancer clinical trial (EP-CT) participation.

11119 Background: The high costs of care (financial toxicity) represent a pressing concern in oncology. Little is known about the financial toxicity experienced by EP-CT participants. We sought to describe changes in financial toxicity during EP-CTs and assess associations of change in toxicity with patient characteristics, additional patient-reported outcomes (PROs), and trial reimbursement structure. Methods: We prospectively enrolled adults participating in EP-CTs from 4/2021 – 1/2023. We administered surveys at baseline (between enrollment and Day 1 of trial) and monthly during trial participation. We assessed financial toxicity using the COST tool, graded as low (≥26) and high (0–25) toxicity. We also surveyed baseline hope (Hope Herth Index), quality of life (QOL; FACT-G) and symptom burden (psychological: PHQ-4; physical: ESAS). We calculated within-patient changes in COST score and conducted linear mixed models, controlling for baseline COST score, to determine associations of change in financial toxicity with patient characteristics, baseline PROs, and trial reimbursement structure (using a factor x time interaction term). Results: Of 221 eligible patients, we enrolled 205 (median age = 63.3 years [range 32.8-88.6], 57.1% female). Most common tumors were GI (34.6%) and breast (20.0%). At trial start, 35.0% of patients reported high financial toxicity, 40.5% at 1 month, 33.6% at 2 months, 25.5% at 6 months, and 40.0% at 1 year. Within-patient COST score worsened over time (B=-0.20, p=0.059), although this change did not reach significance. We found no patient characteristics that significantly correlated with change in COST score, including age (B=-0.005, p=0.602), sex (B=-0.097, p=0.667), GI cancer (B=-0.11, p=0.118), annual income &gt;$60,000 (B=-0.10, p=0.306), and current employment (B=-0.34, p=0.121). Higher baseline QOL was associated with increased COST score (financial wellbeing, while on trial (B=0.012, p=0.011); there was no significant association with other baseline PROs. Most patients (64.4%) enrolled on trials that offered reimbursement for study costs. Of those offering reimbursement, 40.1% had all research-specific costs reimbursed. There was no significant association between change in COST score and presence of any reimbursement (B=0.12, p=0.614) or presence of full reimbursement (B=-0.072, p=0.784). Conclusions: In this cohort of EP-CT participants, over one-third reported high rates of financial toxicity, which appeared relatively stable over time on trial. We did not identify any demographic factors associated with risk of worsening toxicity but did find that high baseline QOL may be protective. Trial reimbursement did not lead to improvement in financial wellbeing. Findings demonstrate that EP-CT participation may not place excess financial burden on at-risk patients and highlight the need to monitor for financial toxicity across all trial participants.

Coping strategies and patient-reported outcomes (PROs) in early-phase cancer clinical trial (EP-CT) participants.

e23194 Background: Individuals with cancer often rely on various coping strategies as they navigate their cancer course. Little is known about coping strategies among patients enrolled on EP-CTs or associations of these coping strategies with other PROs. Methods: We prospectively enrolled adults with cancer participating in EP-CTs at Massachusetts General Hospital from 4/2021-1/2023. Participants completed baseline surveys prior to EP-CT initiation that assessed coping strategies (Brief COPE), quality of life (QOL; Functional Assessment of Cancer Therapy-General), hope (Herth Hope Index), depression/anxiety symptoms (Patient Health Questionnaire-4), and financial wellbeing (COST tool). We used regression models to explore associations of coping strategies with patient characteristics and PROs (QOL, hope, depression/anxiety symptoms, financial wellbeing). Results: Among 205 participants (median age = 63.3 [range: 31.8-88.6], 57% female), the most common cancer types were gastrointestinal (35%) and breast (20%). Patients in this cohort utilized the following coping strategies (range 0-6): acceptance (mean = 4.81), emotional support (mean = 4.63), active (mean = 4.30), positive reframing (mean = 3.13), religion (mean = 2.77), self-blame (mean = .87), denial (mean = .59), and behavioral disengagement (mean = .36). Older age was associated with decreased use of self-blame coping (B = -0.02, p = .025). Female sex was associated with higher scores for denial (B = 0.42, p = .009), emotional support (B = 0.50, p = .037), positive reframing (B = 0.57, p = .036), and religion (B = 1.02, p = .001) coping compared with males. See table for associations of coping strategies with PROs (QOL, hope, depression/anxiety symptoms, financial wellbeing). Conclusions: In this cohort of EP-CT participants, we demonstrated that patients use multiple coping strategies and identified differences by age and sex. Notably, we found that some coping behaviors (acceptance, emotional support, positive reframing) were more favorably associated with QOL, hope, depression/anxiety symptoms, and financial wellbeing than others (denial, self-blame, behavioral disengagement). Interventions seeking to enhance PROs in this population should address patients’ use of coping strategies. [Table: see text]

Expansion of outreach to native Hawaii and Pacific Islander communities to increase breast cancer screening and clinical trial awareness in underserved and rural Oahu.

e13725 Background: Multiple barriers exist in the enrollment of racial and ethnic minority groups into breast cancer screening and clinical trials. Such barriers include the lack of knowledge, mistrust, and access. To increase participation of rural-dwelling Native Hawaiian/Pacific Islanders (NHPI) and other underserved minority groups in breast cancer screening and clinical trials, a pilot project was developed to augment community engagement, provide education, and gain insights into the cancer screening/clinical trial process. Our objective was to engage rural Oahu's underserved communities in breast cancer screening and facilitate enrollment into the Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients of Breast Cancer Trial (TMIST) utilizing a team comprising of a cultural congruent and gender concordant Community Health Educator (CHE) and medical oncology health care provider. Methods: We reviewed the community activities over the course of a year. The CHE facilitated outreach by speaking at numerous church events and other community gatherings. Results: Participants did not respond favorably to surveys on social determinants of health. Common reasons for their reluctance included lack of perceived importance and medical mistrust. When discussing verbiage that was intimidating or confusing such as clinical trial protocol consent language, TMIST study participants conveyed a strong sense of dehumanization. Conclusions: A total of 93 women were screened for the TMIST clinical trial. Of those, 13 were enrolled in TMIST and 31 participants received mammograms. Participant insight highlighted the importance of education using culturally sensitive language and community engagement to combat the lack of knowledge and mistrust. Continued development of education materials centered around community involvement will improve the accrual of NHPI participation in breast cancer screening/clinical trials. We hope this project established a basis for equity in communities with low breast cancer screening and clinical trial participation rates. We intend to build upon the community partnerships forged during this pilot project.

Associations of symptom burden with patient-reported outcomes (PROs) and clinical outcomes among early-phase cancer clinical trial (EP-CT) participants.

11101 Background: Individuals with cancer often endure a substantial physical and psychological symptom burden. However, little is known about the baseline symptom burden of patients with cancer participating in EP-CTs or the associations of this symptom burden with other PROs and clinical outcomes. Methods: We prospectively enrolled adults with cancer participating in EP-CTs at Massachusetts General Hospital from 4/2021-1/2023. Participants completed baseline surveys prior to EP-CT initiation that assessed symptoms (Edmonton Symptom Assessment System [ESAS]), quality of life (QOL; Functional Assessment of Cancer Therapy-General), hope (Herth Hope Index), depression/anxiety symptoms (Patient Health Questionnaire-4 [PHQ-4]), and financial wellbeing (COST tool, higher scores indicate greater financial wellbeing). We used regression models to explore associations of baseline symptom burden with other PROs (QOL, hope, depression/anxiety, financial wellbeing) and clinical outcomes (time on trial, hospitalizations, overall survival). Results: Among 205 participants (median age=63.3 [range: 31.8-88.6], 57.1% female), the most common cancer types were gastrointestinal (34.6%), breast (20.0%), and head and neck (10.2%). Based on the ESAS, approximately half of participants reported moderate/severe fatigue (50.2%) and poor wellbeing (49.5%). Under half reported moderate/severe drowsiness (35.7%), pain (25.9%), lack of appetite (25.4%), shortness of breath (20.0%), anxiety (18.0%), depression (15.4%), and nausea (9.2%). Higher baseline ESAS total, physical, and psychological scores were associated with worse QOL, lower hope, greater PHQ-4 depression/anxiety symptoms, and worse financial wellbeing (see Table). Higher baseline ESAS scores were associated with decreased time on trial and worse overall survival. Conclusions: In this study of EP-CT participants, we found associations of baseline symptom burden with other important PROs and clinical outcomes. Specifically, higher baseline symptom burden was associated with decreased QOL, lower hope, increased depression/anxiety symptoms, and diminished financial wellbeing as well as greater risk for shorter time on trial and worse survival. Interventions seeking to enhance care delivery and outcomes for EP-CT participants should strive to address the symptom burden of this population. [Table: see text]

Access to cancer center information for patients with limited English proficiency from NCI Cancer Center websites.

e23124 Background: Patients with Limited English Proficiency (LEP) can experience health disparities in cancer care and clinical trial participation. This study sought to assess the availability of information on interpreter services, clinical trials, and second opinions from National Cancer Institute – Designated Cancer Center (NCI-DCC) websites for patients with LEP. Methods: The public facing websites of all 65 adult NCI-DCCs were reviewed from January 1, 2023 to May 15, 2023 to assess availability of English and translated, non-English information on interpreter services, second opinion programs, and clinical trials. Data abstraction was conducted through predefined criteria for website inspection and search bars. Three authors independently abstracted websites for content, with constant comparison until consensus was achieved. Chi-square tests were used to ascertain any significant association between the proportion of LEP populations served by the centers ( &gt; 5%) and their likelihood to provide translated information. Results: 92.3% of NCI-DCCs and their affiliated flagships hospitals provide information on interpreter services for patients with LEP. This information was translated into a non-English language approximately half of the time. All NCI-DCC center webpages provide information on clinical trials and 38.5% provide information regarding second opinions. There was no difference in the availability of translated information on interpreter services or second opinion programs based on percentage of LEP population. However, there was an association between higher LEP population and the provision of translated clinical trial pages. Conclusions: The majority of NCI-DCCs provide information on their webpages related to interpreter services and clinical trials. Half of these centers provide this information in a non-English language and there was an association between higher percentage of LEP populations in the NCI-DCC state and translated clinical trial pages. Future work should identify optimal methods to provide cancer related information to patients with LEP with the goal of improving clinical trial participation for LEP populations. [Table: see text]