Participation In Cancer Clinical Trials Research Articles

"Do it!" Gynecologic cancer clinical trial participants' advice to others and perspectives

"Do it!" Gynecologic cancer clinical trial participants' advice to others and perspectives

Ethnicity and Socioeconomic Disparities in Clinical Trial Participation for Ovarian Cancer: A Retrospective Observational Study in London

Background: Ethnic and socioeconomic disparities in cancer outcomes are exacerbated by clinical trial underrepresentation. This study aims to identify inequalities in ethnicity and socioeconomic features among ovarian cancer clinical trial participants in two London cancer centres. Methods: All ovarian cancer patients treated between 2017 and 2022 were included. Patients participating in clinical trials were classified as the trial population (TP); the remainder were considered the non-trial population (NTP). Data on disease characteristics and sociodemographic features, including ethnicity and Indices of Multiple Deprivation (IMD) deciles, were accessed from electronic patient records. Results: Of the 892 patients, 212 (24%) were enrolled in trials: 87 in Phase II, 103 in Phase III, and 21 in prospective, non-investigational medicinal product trials. The TP were more likely to be of White ethnicity (72.6% vs. 57.5%; p < 0.001), younger (mean age 58 vs. 60; p = 0.003), living in less deprived areas (most deprived tercile: 21.2% vs. 34.0%; p = 0.004), and English-speaking (95.8% vs. 90.9%; p = 0.041). In the multivariate analysis, White ethnicity (p < 0.0001), age (p = 0.003), IMD decile (p = 0.007), and interpreter requirement (p = 0.037) were independent predictors of trial participation. Conclusions: Ethnic and socioeconomic inequalities affect trial participation, potentially worsening health disparities in ovarian cancer patients. Strategies to overcome trial recruitment barriers for underserved groups are needed to improve the equity of care.

Financial toxicity in early-phase cancer clinical trial participants.

Little is known about financial toxicity in early-phase clinical trial (EP-CT) participants. This study sought to describe financial toxicity in EP-CT participants and assess associations with patient characteristics and patient-reported outcomes (PROs). Prospectively enrolled EP-CT participants from were followed from April 2021 through January 2023. Participants completed the Comprehensive Score for Financial Toxicity (<26=financial toxicity) at time of treatment. Quality of life (QOL), symptoms, coping, and resource concerns were surveyed. Associations of financial toxicity with patient characteristics, PROs, and clinical outcomes were explored. Of 261 eligible patients, 197 completed baseline assessments (75.5%, median age=63.4 years [31.8-88.6], 57.4% female). Most common cancers were gastrointestinal (33.0%) and breast (20.8%). More than one third (34.0%) of patients reported financial toxicity. Patients with financial toxicity were more likely to be<65 years (70.2% vs 48.5%, p=.004), unemployed (45.5% vs 16.9%, p<.001), not have attended college (53.1% vs 26.4%, p=.002), and have income <$60,000 (59.7% vs 25.4%, p<.001). In adjusted models, patients with financial toxicity reported lower QOL (B=-6.66, p=.004) and acceptance (B=-0.78, p=.002), and increased self-blame (B=0.87, p<.001). They were more likely to have concerns regarding housing (10.6% vs 2.3%, p=.025), bills (31.8% vs 3.8%, p<.001), food (9.1% vs 0.8%, p=.006), and employment (21.2% vs 1.5%, p<.001). There was no difference in time on trial (hazard ratio, 1.03; p=.860) or survival (hazard ratio, 1.16; p=.496). More than one third of EP-CT participants reported financial toxicity. Factors associated with financial toxicity and demonstrated novel associations among financial toxicity with QOL, coping, and resource concerns were identified, highlighting the need to address financial toxicity among this population.

Enhancing minority participation in cancer clinical trials: Insights from a mixed methods study.

70 Background: The urgency to enhance cancer clinical trial enrollment among racial and ethnic minority patients is underscored by the rise in novel therapies. This study examines referral mechanisms from a community-based oncology care clinic to an academic medical center, evaluates the clinical trial knowledge of minority groups, and explores perceptions and attitudes toward trials. Methods: Using a sequential explanatory mixed methods research design, Clinical Trial Knowledge Survey was administered to patients seen at the Hem/Onc clinic in a community-medical center. Descriptive statistics were calculated and multivariate analysis were used to examine associations between variables using STATA 18. Qualitative data from 10 semi-structured interviews were analyzed by two independent investigators using NVivo 14. Themes were identified through a combination of deductive and inductive approaches. Results: Of the 502 mailers sent, 97 individuals responded (response rate of 9.56%). Average age of participants was 54 years, predominantly single and African American. Majority of the of respondents (62%) agreed that patient participation is crucial for generating new and effective treatments. 65% believed that clinical trials are typically conducted on drugs presumed to be effective. However, 32.99% of the respondents perceived participation in clinical trials as a frightening experience. Four qualitative themes emerged: (i) Engagement with one’s health varied between participants. (ii) While clinical trial awareness was limited, willingness to participate was strongly endorsed. (iii) Clinical trial decision-making is a complex process heavily influenced by awareness of and attitudes toward clinical trials. (iv) There is a need to tailor educational strategies to increase awareness of and participation in clinical trials. Conclusions: Our findings emphasize the critical role of awareness and tailored, culturally congruent educational strategies that are crucial to bridge the knowledge gap, alleviate hesitations, and enhance cancer clinical trial participation rates among racial and ethnic minorities.

Participation in Non-small Cell Lung Cancer Clinical Trials in the United States by Race/Ethnicity

IntroductionDespite efforts by Cancer Centers and community organizations to increase diversity in clinical trials, significant racial/ethnic disparities remain. Given the high mortality rates in non-small cell lung cancer (NSCLC), it is important to increase diversity in NSCLC trials, ensuring all patients benefit from advances in new treatment modalities. Materials and MethodsWe evaluated the distribution of racial/ethnic minority enrollment in NSCLC clinical trials using data from ClinicalTrials.gov. We extracted trial characteristics, including start year, study phase, tumor stage, sample size, sponsor, geographic region, and masking. The number of participants by race/ethnicity was obtained from ClinicalTrials.gov or linked publications. Using annual NSCLC incidence data from SEER*Stat for each racial/ethnic group from 2010 to 2019, we applied a 2-sample test for equality of proportions with continuity correction to assess differences between incidence and trial participation. ResultsA total of 147 unique studies were included in the final analysis. Of the 28,540 participants, 79.6% were White, with 3% Black, 10.4% Asian or Pacific Islander and 3.4% Hispanic/Latino. Most participants were enrolled in phase III trials (63.8%), industry-sponsored (93.9%), and open-label (67.7%). Black patients were more commonly enrolled in academic sponsored trials and less commonly enrolled in masked (i.e., blinded) studies. When comparing trial participation to annual incidence data, we observed underrepresentation among Black participants (Difference: −7.9%) and Hispanic/Latino participants (Difference: −3.2%). ConclusionPersistent underrepresentation exists in NSCLC clinical trials among Black and Hispanic/Latino patients. We urge further investigation of these findings through well-designed clinical trials among diverse patient populations.

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

245 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. Coping Strategy QOL Depression Anxiety Hope Financial Wellbeing Beta P Beta P Beta P Beta P Beta P Denial -2.81 .001 0.27 &lt;.001 0.39 &lt;.001 -1.26 &lt;.001 -0.96 .100 Active 0.51 .428 -0.06 .315 0.01 .874 0.98 &lt;.001 0.84 .065 Acceptance 3.13 &lt;.001 -0.15 .013 -0.22 .004 1.31 &lt;.001 1.40 .003 Self-Blame -5.30 &lt;.001 0.44 &lt;.001 0.56 &lt;.001 -1.35 &lt;.001 -2.94 &lt;.001 Emotional Support 1.34 .023 -0.12 .014 0.004 .945 1.03 &lt;.001 0.39 .328 Positive Reframing 1.19 .027 -0.11 .020 -0.08 .184 1.12 &lt;.001 0.13 .715 Behavioral Disengagement -5.99 &lt;.001 0.62 &lt;.001 0.52 &lt;.001 -2.66 &lt;.001 -1.38 .112 Religion 0.57 .195 -0.04 .307 -0.01 .812 0.62 &lt;.001 -0.31 .309

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

244 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 (see Table). 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. Outcomes ESAS Total ESAS Physical ESAS Psychological PROs Beta P Beta P Beta P QOL -0.55 &lt;0.001 -0.68 &lt;0.001 -1.93 &lt;0.001 Hope -0.10 &lt;0.001 -0.09 &lt;0.001 -0.53 &lt;0.001 PHQ-4 Depression/Anxiety 0.06 &lt;0.001 0.06 &lt;0.001 0.39 &lt;0.001 Financial Wellbeing -0.13 0.003 -0.16 0.009 -0.36 0.032 Clinical Outcomes HR P HR P HR P Hospitalizations 1.01 0.066 1.02 0.059 1.03 0.290 Time on Trial 1.01 0.069 1.01 0.208 1.04 0.046 Overall Survival 1.02 &lt;0.001 1.03 &lt;0.001 1.04 0.088

An updated comparative analysis of needs and role of patient navigation among early phase cancer clinical trial participants and non-participants at a single cancer center.

237 Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptom burdens. EPCTs may add to these burdens by requiring frequent, long visits and additional procedures. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters and SDoH barriers between the EPCT and non-EPCT pt groups. Results: From February 2023 to April 2024, 40 EPCT pts and 1290 non-EPCT pts completed the assessment. Median age was 60.5 and 63.1 years, respectively. Racial and ethnic self-identification included 17.5% vs. 19% Black pts and 10% vs. 17% Hispanic pts. EPCT pts had a mean 5.2 navigation encounters per pt compared to 3.05 in non-EPCT pts (p=0.002). Pts in the EPCT group were found to have an average of 2.8 SDoH barriers identified, in contrast to 2.0 in the non-EPCT group (p=0.002). The most common barriers identified in EPCT pts were institutional, knowledge, psychosocial and financial; in non-EPCT pts, transportation, institutional, knowledge and treatment adherence were most common. Interventions related to institutional barriers most frequently involved coordinating with the primary team and among departments. Interventions related to knowledge included providing education and teach back. Conclusions: EPCT pts had more SDoH barriers identified, higher acuity of barriers, and required more navigation encounters than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. EPCT pts Non-EPCT pts p value Navigation encounters, mean (SD) 5.20 (6.16) 3.05 (4.34) 0.002 SDoH barriers identified, mean (SD) 2.82 (1.83) 2.00 (1.66) 0.002

Abstract B123: Multilevel influences on Black and Hispanic/Latine patient participation in early phase cancer clinical trials

Abstract Black and Hispanic/Latine patients are disproportionately burdened by cancer yet underrepresented in cancer clinical trials. Diverse participation in cancer clinical trials is essential to identify potential group differences in risks and benefits and to ensure equitable access to cutting-edge therapeutics. Prior research has focused on barriers to representation in later phase trials with less focus on early phase cancer clinical trials (EPCCTs). EPCCTs may include unique barriers to representation based on safety focus and intensive monitoring. We investigate multi-level influences on EPCCT participation for Black and Hispanic/Latine patients through in-depth qualitative interviews with (n=30) Black or Hispanic/Latine metastatic cancer patients and (n=30) oncology providers/staff from two community practices. Using the Ecological Model as a guiding framework, we explored facilitators and barriers to diverse EPCCT participation at the patient level, provider level, health system/policy level, and community level. We utilized Rapid Qualitative Inquiry to gain pragmatic, accurate understanding. At the patient level, we identified informational (e.g., understanding of cancer), emotional (e.g., trust), and instrumental (e.g., transportation) influences on Black and Hispanic/Latine participation. The most pervasive barrier to EPCCT inclusion was lack of invitation for Black and Hispanic/Latine patients. At the provider/staff level, key barriers to representation included low EPCCT knowledge among providers, preconceptions about barriers for Black and Hispanic/Latine patients, and perceived loss of control/relationship with patients/caregivers. At the health system/policy level, critical barriers included insufficient time to discuss EPCCTs, concerns about impact of trials on systems (e.g., wait-time for scans), and provider discomfort with referral process (sending patients to Phase I team without specific trial knowledge). At the community level, salient influences on patient decision-making were identified (e.g., peers, youtube). We conducted a systemwide survey of (n=81) oncology providers and their attitudes, beliefs, and behaviors regarding EPCCTs; we determined how attitudes and beliefs related to EPCCT referral behaviors. We have planned interventions to mitigate each barrier and leverage each facilitator to increase representation. It is critical to identify and address relevant local barriers to ensure equitable access to novel therapeutics and generalizability of scientific discoveries. Citation Format: Jessica Lewis, Amy Smoyer, Erin Singleton, Marcella Nunez-Smith, Imran Saeed, Patricia LoRusso. Multilevel influences on Black and Hispanic/Latine patient participation in early phase cancer clinical trials [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B123.

Abstract B160: Assessing patient experience in cancer clinical trial participants: Results from a rapid umbrella review with an equity lens

Abstract Introduction: Clinical trials are an important part of cancer care, yet research assessing patient experience in cancer clinical trials is sparse. Ensuring that the patient voice is heard and valued in the context of clinical trials is critical to the delivery of high-quality, patient-centered, and equitable cancer care. Furthermore, understanding the aspects of cancer clinical trials that are important to and reported by patients may inform strategies to address barriers to clinical trial participation, improve diversity in clinical trials, and advance health equity, particularly among populations underrepresented in clinical research. This rapid umbrella review sought to understand how patient experience is assessed in cancer clinical trials and to identify opportunities to integrate an equity lens. Methods: PubMed, Embase, Cochrane, and CINAHL databases were searched for systematic reviews that identify and describe development, use, or testing of tools/instruments assessing patient experience of cancer clinical trial patients. The search strategy was collaboratively developed with an NIH Librarian, using a combination of key terms to describe: 1) patient experience, 2) clinical trials, 3) healthcare delivery, and ) systematic reviews. The search was limited to publications in the English language and a date range of 2018-2024. One co-author completed the title and abstract review based on the inclusion criteria. Two reviewers will then independently completed the full text review, quality appraisal, and data abstraction for all included studies. All authors will synthesize data into matrix tables and narratively summarize into key themes. Discrepancies were resolved through discussion. Results: Out of 1,751 yielded search results, 151 articles were preliminarily identified. Upon further reading of the full texts, the final list of included articles meeting inclusion criteria will be reported using Covidence. Summary findings from this rapid umbrella review will include the number of studies identified, clinical trials population, a description of the patient experience measures, domains, findings, as well as opportunities for health equity integration using the PROGRESS-Plus Framework. Conclusion: Equitable representation in clinical trials will require intentional efforts to understand and enhance the experience of patients on clinical trials across diverse patient populations, as well as address barriers to participation. However, there are several research gaps that limit our understanding in this area, including a lack of consistent definitions, patient experience domains; availability and use of standardized, validated measures for clinical trial populations, and knowledge about what factors differ and influence patients’ experiences, particularly among populations underrepresented in clinical research. Attention to these gaps will facilitate a greater understanding of patient needs, experiences, and barriers, and may promote actionable strategies to increase access to, inclusion of, and diversity in cancer clinical trials. Citation Format: Brenda Adjei, Katrina Makres, Eric Juarez, Sae-Jin E Lee, Lynne Padgett. Assessing patient experience in cancer clinical trial participants: Results from a rapid umbrella review with an equity lens [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B160.

Abstract B033: Understanding Latinas’ decisions to participate in a unique breast cancer clinical trial: A qualitative constructivist grounded theory study

Abstract Background &amp; Objective: Breast cancer is the most common cause of cancer death in Latinas in the United States; however, researchers often fail to use recruitment messaging targeted toward increasing Latina participation. Although the cancer disparities observed among this population are significant, these group members account for only 1.3% of cancer-related clinical trial participants in the United States. The barriers preventing Latinas’ participation in research are well-established, but there are few studies focused on comprehending the motivations of Latinas who previously volunteered for clinical trial participation. The aims of this study were to improve the understanding of Latinas’ decisions to participate in a unique breast cancer clinical trial and to propose future methods for increasing these group members’ motivations regarding medical research participation. Methods: Guided by constructivist grounded theory, twenty women (N= 20) who self-identified as Latina or Hispanic, and who had previously donated healthy breast tissue to a biobank that was part of a clinical trial, were interviewed regarding their medical research participation decisions. Participants were recruited through direct email and interviews were conducted over Zoom and Microsoft Teams. Results: Findings revealed three primary themes: (1) the availability of both bilingual recruitment materials and research team personnel were viewed as important motivators to participate, (2) the knowledge of their underrepresentation in medical research and the understanding that their participation may help Latinas in the future were revealed as important motivators to participate, and (3) individuals who received negative feedback from family and/or friends about their intended research participation remained resolute in their decision to donate tissue. Conclusions: Understanding the motivations of Latinas who have previously participated in cancer-related clinical trials can help researchers create targeted and/or tailored recruitment messaging. Messaging must emphasize the consequences of underrepresentation of Latinas in clinical trials, be bilingual, and communicate that participation in cancer clinical trials can positively impact the health of other Latinas in the future. Citation Format: Katherine E. Ridley-Merriweather, Katherine Vogel. Understanding Latinas’ decisions to participate in a unique breast cancer clinical trial: A qualitative constructivist grounded theory study [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B033.

Smoking prevalence and association with sociodemographic variables in cancer clinical trial participants.

Tobacco use (smoking) causes adverse clinical outcomes among patients with cancer, including increased cancer-related mortality. In participants in cancer clinical trials, the prevalence of tobacco use and the factors associated with tobacco use are not well described. Data were examined from participants enrolled in SWOG cancer clinical treatment trials between 2016 and 2022 who reported their smoking status at trial enrollment. Baseline variables (smoking status, insurance type, zip code, and demographic factors) were obtained from patient registration forms. Bivariate and multivariable associations were examined via logistic regression. Among 4326 patients enrolled in 29 trials, 48.1% reported currently/previously smoking, including 12.4% currently, 4.9% recently, and 30.7% formerly. Ever smoking was more commonly reported in males, patients aged ≥65 years, patients with Medicaid or no insurance, patients from areas of high socioeconomic deprivation, and rural patients. Patients of Hispanic ethnicity and Asian and Pacific Islander patients were less likely to have ever smoked. In multivariable regression, patients with lung cancer were most likely to report ever smoking compared to patients with breast cancer (odds ratio,4.98; p<.001). In the first comprehensive evaluation of smoking status among trial participants enrolled in National Cancer Institute network group treatment trials, nearly half reported ever smoking and one in six reported current or recent smoking. Smoking was more common among vulnerable population patients defined by demographic and socioeconomic factors. Tobacco use should be routinely assessed and reported in clinical trials to help reduce the negative cancer and overall health effects of persistent tobacco use and to address disparities among patients with cancer.

Gender, Race, and Ethnicity in Lung Cancer Clinical Trial Participation: Analysis of 253,845 Patients From 2002 – 2021

Lung cancer remains the largest cause of cancer-related death, and multiple large studies have identified persistent racial disparities in lung cancer outcomes. In this study, we utilize public recording of lung cancer data on clinicaltrials.gov to sample age, gender, racial, and ethnic characteristics of participants in lung cancer clinical trials. Clinicaltrials.gov, a US federal government repository of clinical trials was queried for the term "lung cancer" and several other related terms. A list of all studies matching these criteria was generated and information regarding age, gender, ethnicity, and racial breakdown of participants was analyzed. Studies that did not report results to clinicaltrials.gov or had at least one non-US site were excluded. Hypothesis testing was performed with Student's T-test and Chi-squared testing. Trends were analyzed using Spearman testing in Python (VS Code, Microsoft, Redmond, WA 2023) RESULTS: Rates of minority (non-white) and female participation in US lung cancer clinical trials have exhibited a significant increase (p<0.01) over the last 20 years (2002-2021, Figures 1) but still do not represent parity with lung cancer incidence. Subset analysis by offered intervention did not show a significant difference between studies that offered surgical or non-invasive intervention in race, gender, or ethnic participation. NIH-funded studies do not appear to have recruited any Hispanic participants as assessed by reporting on clinicaltrials.gov. The rates of race and ethnicity reporting have also significantly increased over the last 20 years (Figure 1C). Our data demonstrate that there are persistent but improving racial and ethnic disparities in lung cancer clinical trials. Limitations of this study include poor reporting of results on clinicaltrials.gov. These findings demonstrate significant progress in the recruitment of minority participation, but also identify a significant role for policy changes to align participation with lung cancer incidence.

Disparities in clinical drug trial participation in endometrial cancer: a real-world analysis

Racial disparities in clinical trial participation for uterine cancer have been reported. We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States. We conducted a retrospective cohort study of patients with advanced or recurrent patients with endometrial cancer diagnosed from 2013 to 2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors. Of 4423 patients with endometrial cancer, 2807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of patients with endometrial cancer ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (risk ratio (RR) 2.28, 95% confidence interval (CI) 1.12-4.62 and RR 2.59, 95% CI 1.26-5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95% CI 0.30-0.83). Black patients with endometrial cancer were disproportionately underrepresented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.

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.