Awareness Of Clinical Trials Research Articles

Barriers to participation by minorities in oncology clinical trials.

68 Background: Clinical trial (CT) diversity remains low despite numerous countermeasures. We investigated barriers to CT participation in our racially/ethnically diverse cancer population while considering loco-regional differences. Methods: An IRB-approved 32-item survey was administered to eligible patients in English or Spanish depending on patient preference. Comparisons were made between groups with ANOVA for age and chi square tests for categorical variables using an alpha of 0.05. Results: 276 responses were analyzed. Spanish-speaking (“Spanish”) respondents were younger, with 29.5% between 31–49 yrs. [vs. 13.3% of English-speaking (“English”) respondents] and 15.8% were >70 yrs. (vs. 28.2%; p=0.004). 41.1% and 27.4% of Spanish respondents were single and married, respectively, compared to 19.9% and 49.7% of English respondents (p<0.001). 32.7% of Spanish respondents had attended and/or graduated college vs. 72.1% of English respondents. 79.6% of English respondents were born in one of the 50 US states (vs. 8.4% of Spanish respondents), while 58.9% of Spanish respondents were born in Puerto Rico. 4.2% of Spanish respondents preferentially spoke English at home. There was no association between CT awareness/invitation to participate and previous diagnosis of cancer, nor between CT awareness and place of birth. However, differences between English and Spanish respondents were observed (Table). Additionally, insurance coverage showed a significant difference among all respondents, with respondents on private insurance more likely to have heard about CT than those with public or no insurance (51.3% vs. 16.4%, resp.; p<0.001). Invitation to participate in CT was higher in the English group (p=0.002), although there was no difference among Hispanics who spoke English at home (p=0.420). Place of birth remained statistically significant for CT participation; 87.5% of those offered were US born (p=0.020). Conclusions: CT awareness continues to be higher in English-speaking cancer patients, and those with private insurance. Inequalities appear to be minimizing in Hispanics with certain acculturation degree. However, CT offering continues to exclude Hispanics, even those who have adopted English as primary language, regardless of place of birth. These findings support efforts to increase CT education in minority populations, and demonstrate certain healthcare bias for CT offering which will need to be addressed to guarantee CT diversity and health equity. Clinical trial (CT) awareness. Variable/characteristic English-speaking Spanish-speaking P value* Sample size 181 (65.6%) 95 (34.4%) --- CT awareness 153/161 (95.0%) 33/85 (38.8%) <0.001 CT awareness among Hispanics 11/14 (78.6%) 30/80 (37.5%) 0.007 *bold denotes statistically significant at p<0.05.

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.

Exploring Racial Disparities in Awareness and Perceptions of Oncology Clinical Trials: Cross-Sectional Analysis of Baseline Data From the mychoice Study.

Black/African American adults are underrepresented in oncology clinical trials in the United States, despite efforts at narrowing this disparity. This study aims to explore differences in how Black/African American oncology patients perceive clinical trials to improve support for the clinical trial participation decision-making process. As part of a larger randomized controlled trial, a total of 244 adult oncology patients receiving active treatment or follow-up care completed a cross-sectional baseline survey on sociodemographic characteristics, clinical trial knowledge, health literacy, perceptions of cancer clinical trials, patient activation, patient advocacy, health care self-efficacy, decisional conflict, and clinical trial intentions. Self-reported race was dichotomized into Black/African American and non-Black/African American. As appropriate, 2-tailed t tests and chi-square tests of independence were used to examine differences between groups. Black/African American participants had lower clinical trial knowledge (P=.006), lower health literacy (P<.001), and more medical mistrust (all P values <.05) than non-Black/African American participants. While intentions to participate in a clinical trial, if offered, did not vary between Black/African American and non-Black/African American participants, Black/African American participants indicated lower awareness of clinical trials, fewer benefits of clinical trials, and more uncertainty around clinical trial decision-making (all P values <.05). There were no differences for other variables. Despite no significant differences in intent to participate in a clinical trial if offered and high overall trust in individual health care providers among both groups, beliefs persist about barriers to and benefits of clinical trial participation among Black/African American patients. Findings highlight specific ways that education and resources about clinical trials could be tailored to better suit the informational and decision-making needs and preferences of Black/African American oncology patients.

Abstract A107: Be Part of the Cure Clinical Trials Campaign: Koreans, Hispanic/Latino/a/e/x, and Black/African Americans living in Los Angeles County

Abstract Background. There is negative perception and lack of participation in clinical trials among Koreans, Hispanic/Latino/a/e/x, and Black/African Americans living in Los Angeles County, which may be attributed to cultural beliefs, language barriers, historical mistrust of medical research, and lack of awareness about the benefits of participation. Without representation from diverse groups, there may be missed opportunities to develop personalized treatment approaches tailored to specific genetic, cultural, and lifestyle factors. Methods. Cedars Sinai Cancer Community Outreach and Engagment (COE) developed a multi-level approach to increase representation of minority populations in clinical trials. With active Community Advisory Board involvement in the development and implementation, a culturally sensitive clinical trials awareness campaign, “Be Part of the Cure”, was developed to offer in-language cancer information, education on clinical trials, and navigation through the cancer care continuum. To support patients and facilitate access to trials, COE has developed bi-directional engagement between CCSC physicians, nurses and Clinical Trials Office representatives, FQHCs, and community and faith-based organizations to ensure a seamless navigation process to care. Additionally, our multicultural and multilingual COE staff have trained Community Health Workers and navigators to expand our outreach efforts and effectively engage our target communities. Results. In total, COE has facilitated 7 health education workshops and attended 3 community outreach events with 501 people educated (37% or 184 Black/African American; 25% or 123 Asians; 17% or 87 Hispanic/Latinx; and 21% or 107 White). Pre/post-tests administered to 73 Koreans during health education workshops showed significant increase in positive perception on clinical trials from 57% to 95%. Korean (n=9) cancer patients have expressed interest in clinical trials, and 1 have been enrolled in Neoadjuvant HER2-Targeted Therapy and Immunotherapy with Pembrolizumab clinical trial. Among Hispanic/Latinx/a/o community, 1 clinical trials health awareness workshop was convened with clinicians who presented to promotores, patients, caregivers, survivors and community members. There were 25 people who completed the pre/post test. There was an increase in positive perception on clinical trials from 52% to 100%, willingness to participate from 60% to 96%, and likelihood of encouraging others to participate from 60% to 96%. In the Black/African American community, 1 clinical trials health awareness workshop was also convened. Among attendees, 21 people completed Pre/Post Test and positive perception on clincal trials increased from 47% to 85%, willingness to participate from 43% to 81%, and likehood on encouraging others to participate from 52% to 81%. Conclusion. Efforts to increase diversity and inclusion in clinical trials should focus on culturally sensitive recruitment strategies, language accessibility, community engagement, and building trust between researchers and communities. Citation Format: Ghecemy Lopez, Dong Hee Kim, Zul Surani, Lourdes Barajas. Be Part of the Cure Clinical Trials Campaign: Koreans, Hispanic/Latino/a/e/x, and Black/African Americans living in Los Angeles County [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 A107.

Abstract IA013: Increasing Diversity in Pediatric Cancer Clinical Trials: Challenges and Opportunities

Abstract Although childhood cancer is the leading cause of death by disease past infancy in the US, with 17,000 children younger than 21 years being diagnosed annually, survival has improved dramatically, and is now greater than 80% overall. Because of unequal access to services and adverse Social Determinants of Health (SDOH) affecting underserved populations, disparities in survival exist among minoritized youth with cancer. For example, Hispanic children have higher incidence of certain cancers and poorer survival rates than non-Hispanic White children. Minorities are severely under-represented in research. This means that cancer outcomes data are largely based on data from non-Hispanic White participants, and there is incomplete information to adequately assess treatment benefits for minorities. We showed that 53% of Latino parents declined research participation, compared to 20% of non-Hispanic White parents, in our institution. There are several barriers to informed consent for clinical trials. First, there are no mandates to ensure comprehension, and informed consent forms are complex, long, and difficult to understand. This leaves parents of children with cancer with an incomplete understanding of risks, procedures, randomization, alternative treatments, and the voluntary nature of clinical trial participation. Furthermore, pediatric cancer often requires urgent treatment, leaving little time for decision-making. We developed COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn), a peer-navigation intervention to improve research literacy and diversity in pediatric cancer clinical trials. In this intervention, trained peer-navigators, who have the lived experience of having a child diagnosed with cancer, provide in-hospital support. The goals of COMPRENDO are to improve parents’ informed consent experience and comprehension of informed consent for cancer treatment, to explain to parents terms to be discussed by the oncologist during the treatment conference, to introduce to parents concepts of clinical trials and research, and to facilitate and empower shared decision-making. In a pilot study at Rady Children’s Hospital-San Diego, this intervention showed a significant increase in comprehension of therapeutic trials, particularly in Hispanic and Spanish-speaking parents. The demographics of children with cancer enrolled in clinical trials should be comparable to the US population, and approaches to improve enrollment must also be tailored to specific settings. Structural barriers for participation of minorities should be considered during study and informed consent design and planning. Strategies to increase clinical trial enrollment of minority individuals include: Provider-level training on patient-provider communication, development of linguistically appropriate tools, and promotion of culturally aware staff. Key strategies at the patient-level include building trust; education and awareness of clinical trials; implementation of culture, language, and health literacy-concordant interventions; and initiatives to address adverse SDOH. Citation Format: Paula Aristizabal. Increasing Diversity in Pediatric Cancer Clinical Trials: Challenges and Opportunities [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pediatric Cancer Research; 2024 Sep 5-8; Toronto, Ontario, Canada. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl):Abstract nr IA013.

Screening log: Challenges in community patient recruitment for gynecologic oncology clinical trials

BackgroundClinical trial participation can improve overall survival and mitigate healthcare disparities for gynecologic cancer patients in low-volume community centers. This study aimed to assess the effectiveness of a centrally regulated but administratively decentralized electronic screening log system to identify eligible patients across a large catchment area for a National Cancer Institute (NCI)-designated cancer center's open clinical trials. MethodsElectronic screening log data collected between 2014 and 2021 from ten community partner sites in a single NCI-designated cancer center's catchment area were reviewed retrospectively. Clinical factors assessed included cancer site, primary versus recurrent disease status, and histology. Identification efficiency (the ratio of patients screened identified with an available trial) was calculated. Identification inefficiencies (failures to identify patients with a potentially relevant trial) were assessed, and etiologies were characterized. ResultsAcross ten community partner sites, 492 gynecologic cancer patients were screened for seven open clinical trials during the study period. This included 170 (34.5 %) ovarian cancer patients, 156 (31.7 %) endometrial cancer patients, and 119 (24.2 %) cervical cancer patients. Over 40 % had advanced stage disease, and 10.6 % had recurrent disease. Only three patients were identified as having a relevant open trial; none ultimately enrolled due to not meeting trial eligibility criteria. An additional 2–52 patients were retrospectively found to have a relevant trial available despite not being identified as such within the electronic screening log system. Up to 14.4 % of patients had one or more missing minimum data elements that hindered full evaluation of clinical trial availability. Re-screening patients when new trials open may identify 12-15 additional patients per recurrent disease trial. ConclusionsAn electronic screening log system can increase awareness of gynecologic oncology clinical trials at a NCI-designated cancer center's community partner sites. However, it is inadequate as a single intervention to increase clinical trial enrollment. Providing adequate support staff, documenting clinical factors consistently, re-screening patients at relevant intervals, and coordinating with central study personnel may increase its utility.

Evaluating awareness and knowledge of clinical trials among people affected by cancer

Evaluating awareness and knowledge of clinical trials among people affected by cancer

Molecular tumor board: Real-world experience in a tertiary cancer centre in Singapore.

107 Background: Genomic profiling is increasingly employed to support diagnosis and treatment of cancer. Our Molecular tumor boards (MTBs) serves as a collaborative platform for a multi-disciplinary team of oncologists, pathologists, scientists, bioinformaticians, genetic counsellors and research coordinators to discuss and match patients to the most relevant therapies and/or clinical trials. We report here the evaluation of our MTBs for year 2023 with the aim of identifying challenges and opportunities for successful implementation of precision oncology. Methods: Regular monthly MTBs were conducted to discuss molecular profiles from predominantly advanced-stage patients enrolled to the IMPACT study (Individualized Molecular Profiling for Allocation to Clinical Trials NCT02806388). Next-generation sequencing was performed either in-house using Oncomine or commercial FoundationOne panels. Additional tests such as whole transcriptome sequencing (WTS), immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH) were also performed where indicated. MTB recommendations were documented for follow-up and analysis. Results: A total of 102 out of 611 profiled patients were discussed in MTBs in 2023, with an average of 8.6 patients per month. Top 3 cancer types were gastrointestinal (32%), breast (18%) and lung (18%). 65/102 (63.7%) cases had MTB recommendations, of which 21 (20.6%) had multiple recommendations. Overall uptake rate for recommendations was 23.8% (29/122). Conclusions: MTB plays an important role in identifying therapeutic opportunities by factoring in patient variables, available data and physician experience while at the same time provides an avenue for further investigation to gather cumulative evidence. Frequent reasons encountered for not adopting the recommendations include: (1) insufficient sample to proceed with further investigations, (2) limited access to off-label treatments, and (3) additional considerations to participate in clinical trials. To fully realize the value of MTB, we will focus on (1) defining the molecular tests for efficient profiling, (2) crafting a route for special access to treatments and (3) increasing awareness and understanding of clinical trials. [Table: see text]

The relationship between trust in federal oversight of vaccine safety and willingness to participate in COVID-19 clinical trials: a repeated measures study of Philadelphia residents (September 2021 – March 2023)

BackgroundThe Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic.MethodsWe used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants’ trust in the federal government’s oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance).ResultsOn average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government’s oversight of vaccine safety [β = 0.34, 95% confidence interval (CI): 0.15–0.53], having COVID-19 (β = 0.40, 95% CI: 0.08–0.73), awareness of clinical trials (β = 0.38, 95% CI: 0.04–0.73), and knowledge of how to enroll (β = 0.83, 95% CI: 0.44–1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness.ConclusionWillingness to participate in clinical trials may be bolstered by strengthening the public’s trust in the federal government’s role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals’ health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

Self-reported awareness of genetic testing, the impact of family history, and access to clinical trials for people diagnosed with ovarian cancer in Australia

ObjectivesTo assess the understanding of people diagnosed with ovarian cancer regarding genetic testing; to understand knowledge gaps among people diagnosed with ovarian cancer that may impact best practice care; and to monitor overall changes in understanding from 2015 to 2022. DesignLongitudinal ’opt-in’ study using an online survey tool at three timepoints: 2015, 2018 and 2022. ParticipantsPeople in Australia (or their families / caregivers) diagnosed with ovarian cancer between 2010 and 2022). Main outcome measuresSelf-reported awareness of heritable risk factors for ovarian cancer, genetic testing approaches and participation in clinical trials. ResultsThe study indicated that there have been improvements in the understanding and awareness of people diagnosed with ovarian cancer regarding familial risk (an increase from 43.6% (45 of 149) in 2015 to 62.9% (166 of 264) in 2022); but people were less likely to be aware of the difference between somatic (tumour) and germline testing (120 of 266, 45.1%). However, there were self-reported improvements to clinical trial access in non-metropolitan areas (12 of 64, 18.8% in 2022 compared to 22 of 145, 15.2% in 2018), bringing it on par with metropolitan areas (32 of 169, 18.9% in 2022). ConclusionsDespite improved awareness about genetic testing among people diagnosed with ovarian cancer, there remain knowledge gaps in understanding of genetic testing types (germline and somatic) and gene variant targeted therapies; and further work to improve clinical trial awareness and access is required.

Improving the multiple myeloma and clinical trial awareness among Los Angeles County adults.

e23108 Background: Multiple Myeloma (MM) is the second most common bone marrow cancer in the United States. The prominent risk factors include Black race and male gender. The purpose of this study was to assess the awareness of MM and clinical trial access among a diverse community of people in the Los Angeles County, and to educate the participants. Methods: An IRB-approved Qualtrics survey was administered electronically to a group of 132 participants aged 18 years and older in Los Angeles County between May 3rd and July 15th of 2023. The survey investigated participants’ knowledge on MM risk factors and symptoms, as well as their understanding and attitudes towards resource and clinical trial access. Information on participant demographics was also collected. Statistical tests including chi-square analysis, descriptive statistics, filtering and sub-setting, and correlation analysis, were all utilized and conducted using the software, R-Studio. MiOra Health Educators provided face-to-face education on MM and clinical trials using CDC-based flyers. Results: Out of 132 respondents, 40 (30.3%) were male, 92 (69.7%) were Latinx, and 78 (59.0%) were a first-generation resident of the United States. 71 out of 92 females (77.4%) and 9 out of the 40 males (22.6%) reported attending their annual wellness visit. Prior to the educational intervention, only 6 out of the 132 participants (4.5%) reported being very knowledgeable about cancer and the way it works. Interestingly, 87 (65.9%) reported being aware of the familial risk of MM. 77 (58.1%) of the respondents reported not knowing what a clinical trial is and clinical trial awareness was found to be the main factor predicting the willingness to participate in one (p &lt; 0.01). 108 (81.8%) of the respondents reported that hearing from past clinical trial participants may be useful, but 111 (84.1%) reported that healthcare professionals (including primary care doctors, nurses, medical practitioners, and oncologists) would be the most appropriate educators on clinical trials. Following the health education intervention, 89 (66.9%) of the respondents reported feeling more knowledgeable about clinical trials, and 93 (70.8%) reported feeling more willing to participate in one. Additionally, 87 (65.9%) reported feeling more knowledgeable about MM risk factors, symptoms, screening, and treatment. Conclusions: Although the risk for MM is higher among males, this group appears to significantly less likely than females to comply with their annual wellness visit, signalling a gender disparity in primary care resource utilization. Knowledge on clinical trials appears to influence participation and although primary care providers are the most trusted resources, community health educators and exposure to past clinical trial participants may help close these gaps in clinical trials.

Educating a diverse group of women in Los Angeles County on ovarian and uterine cancers and clinical trials.

e23105 Background: Ovarian and uterine cancers are among the deadliest cancers for women and due to vague symptoms, diagnosis is often delayed. In addition, there are ethnic disparities in time to diagnosis, treatment, and outcome for these cancers. The purpose of this study was to assess a diverse group of Los Angeles (LA) County women’s understanding of both ovarian and uterine cancers and assess the impact of intervention by community health organizations. Methods: A Qualtrics survey was administered online and in-person to 185 women aged 18 and older in LA County between May 3rd and July 15th 2023. The survey aimed to investigate participants’ knowledge, awareness, and attitudes on women’s cancers’ risk factors, symptoms, screening, treatment options, and clinical trials. Information on participant demographics was also collected. Chi-square analysis, descriptive statistics, filtering and sub-setting, correlation analysis were utilized using R-Studio. MiOra Health Educators provided face-to-face education on ovarian and uterine cancers as well as clinical trials to this sample of participants. Results: Out of 185 respondents, 117 (63.2%) were Hispanic or Latina and 65 (35.1%) reported completing 4 year of college education. 137 (74.0%) reported attending their annual women’s wellness visit. Women with insurance (143, 77.0%) were more likely to report having women’s cancer screening compared to those who were uninsured (71, 38.0%). 93 women (50.3%) reported going to their primary physicians for advice on sexual and/or genital organ health rather than visiting a gynecologist; however older women (aged 41-50) reported seeing their gynecologist more often than the women in younger groups. Moreover, 127 women (68.6%) were aware of clinical trials (the majority being college-educated) however, a majority of the total participants (154, 83.2%) did not know where to locate clinical trials or that one may leave a clinical trial at any time (123, 66.5 %). Prior to educational intervention, only 104 women (56.2%) reported being “somewhat knowledgeable” about women’s cancers’ risk factors and symptoms. Following educational intervention, 143 (77.7%) reported feeling more knowledgeable about women’s cancers’ risk factors and symptoms and 122 (66.6%) reported feeling more knowledgeable about clinical trials and comfortable participating in one. Conclusions: In this pilot study we found that a majority of diverse LA County women attend their annual wellness visits; however, only a small portion receive women’s cancer screening. Lack of insurance appears to be a significant barrier for access to screening tests. In addition to awareness of clinical trials, the ability to locate a clinical trial appears to influence participation in one. Although primary care providers and obstetricians are the most trusted health resources, community health educators may be effective in educating women to close these gaps.

Establishing a protocol to increase racial/ethnic minority enrollment on an active radiation oncology randomized clinical trial.

TPS1638 Background: In the United States (US), underrepresented racial/ethnic groups lack ample enrollment in clinical trials, yielding ungeneralizable trial results. Barriers to increasing minority enrollment include decreased awareness of clinical trials, lack of access, financial burden and toxicity, medical system mistrust, and discordant physician-patient demographics. The ongoing Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) clinical trial (NCT05617716) has a study design to actively accrue minority patients. We present our protocol addressing key targets to increase minority enrollment on this randomized, phase II clinical trial. Methods: Adults with evidence of symptomatic spine metastases are eligible. Baseline demographics (including race/ethnicity) are reported for statistical analysis. Our protocol seeks to minimize barriers to minority enrollment and targets four key areas. Access to care: SPORTSMEN involves institutions located in zip codes with diverse ethnic populations, presently located in regions 46% and 70% African American. Clinical trial design: SPORTSMEN has a prespecified goal of accruing patients to mirror US census representation. The rate of minority enrollment will be reviewed periodically at the discretion of the Data Safety and Monitoring Board. Community outreach and engagement: The trial team will engage with local health care systems to create an alliance within different oncology specialties to provide the basis and benefit for SPORTSMEN and patient-centered education on eligibility criteria, rationale, and intended outcomes. Our principal focus will be providers in prostate, breast, and lung cancers as minorities with these primary site malignancies have a higher propensity to be trial-eligible. Furthermore, we understand the historical mistrust of minorities for the medical community. Therefore, we will engage local grassroot organizations such as churches, community outreach centers, and social clubs to increase awareness of clinical trials and to help foster trust. Financial burden and toxicity: SPORTSMEN does not have direct enrollment costs. A short-course treatment regimen is used to minimize the number of treatment visits required allowing for decreased resources for travel, time lost at work, and additional childcare or eldercare needs. Financial toxicity will be objectively quantified using the validated COST-Functional Assessment of Chronic Illness Therapy survey. Increasing clinical trial diversity is a challenge that must be addressed with meaningful intent to present robust Level 1 data that broadens the understanding of treatment response in all demographics. Our protocol takes a patient-centered approach to achieve the objective of concordant racial/ethnic representation in a randomized clinical trial. Clinical trial information: NCT05617716 .

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.

An online survey on public awareness of drug clinical trials in inland cities of northern China.

The aims of this survey were to investigate the public awareness of drug clinical trials (DCTs) and willingness to participate the DCTs, and provide references for propaganda and science popularization of DCTs. A self-designed questionnaire named "an online survey questionnaire on public awareness of DCTs" was used to conduct an online survey from January to March 2022. The demographic characteristics and the response of participants to the awareness and willingness to participate the DCTs were collected. The factors affecting the public awareness of DCTs were analyzed by single factor and binary logistic regression analysis. One thousand three hundred eighty valid questionnaires were collected, and the respondents' awareness rate of DCTs was 61.1%. Thirteen demographic characteristics including age, gender, education, occupation, work fields, household type, marital status, city type, income, medical insurance, medical expenditure, pressure to seek medical care, financial pressure, both significantly affected the qualified rate of participants' awareness of DCTs (p < 0.001) by single factor analysis. Binary logistic regression analysis indicated that education level, work fields, city type, medical insurance, and medical expenditure affected independently the participants' awareness rate of DCTs (p < 0.001). 52.9% of the participants were willing to take part in DCTs. "to promote medical progress" (54.4%) or "believe doctors" (31.1%) were the most frequent reasons for subjects participating in DCTs. The public awareness rate of DCTs and the willingness to participate in drug clinical were significantly affected by the demographic characteristics of subjects. Thus, targeting the needs of the public, propaganda, and science popularization of DCTs should be carried out and served public health.

Clinical Trial Awareness in the Black Population from the National African Americans with Multiple Sclerosis Registry (P5-4.007)

Clinical Trial Awareness in the Black Population from the National African Americans with Multiple Sclerosis Registry (P5-4.007)

Observational Study for Clinical Trials Participation in Malaysia

Introduction: This observational study was conducted to assess the knowledge, attitudes, and perceptions (KAP) of Malaysians toward participating in clinical trials. It also aimed to look for factors that will influence people’s willingness to participate in trials. We planned and developed future outreach, education tools, and recruitment strategies to increase clinical trial enrolment. Methods: A cross-sectional study was carried out on a randomly selected sample of 398 Malaysian literate adults. An online questionnaire was created and distributed to the respondents. Descriptive statistics were presented in the form of frequency and percentages. The chi-square test was employed to find the association between independent variables. Results: The majority had good knowledge (61.3%) and high awareness (88.7%) of clinical trials. However, most of them were not willing to take part in a clinical trial if they were assigned to a group of unlicensed drugs (90.2%) or randomly assigned (66.1%). The main reasons for participating in trials were recommendations from doctors (46.5%) and the potential for their own benefit (45.7%). Younger age was positively associated with the necessity and confidentiality of clinical trials. Most respondents indicated negative perceptions towards the safety of clinical trials regardless of demographic variables. Conclusion: We gained a better understanding of Malaysian people who are potential participants in a future clinical trial. These findings could help clinical researchers improve their understanding of the participants and develop effective outreach strategies for clinical trial recruitment and retention.

Addressing disparities in cancer clinical trials: a roadmap to more equitable accrual.

The Georgia Center for Oncology Research and Education (Georgia CORE) and the Georgia Society of Clinical Oncology (GASCO) held a one-day summit exploring opportunities and evidence-based interventions to address disparities in cancer clinical trials. The purpose of the summit was to identify clear and concise recommendations aimed at decreasing clinical trial accrual disparities in Georgia for rural and minority populations. The summit included expert presentations, panel discussions with leaders from provider organizations throughout Georgia, and breakout sessions to allow participants to critically discuss the information presented. Over 120 participants attended the summit. Recognizing the need for evidence-based interventions to improve clinical trial accrual among rural Georgians and persons of color, summit participants identified four key areas of focus that included: improving clinical trial design, providing navigation for all, enhancing public education and awareness of cancer clinical trials, and identifying potential policy and other opportunities. A comprehensive list of takeaways and action plans was developed in the four key areas of focus with the expectation that implementation of the strategies that emerged from the summit will enhance cancer clinical trial accrual for all Georgians.

Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

ObjectivesTo explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.DesignQualitative interviews analysed using thematic analysis.Setting and participantsFive professionals (clinical researchers and methodologists) and three patient and...

The association between social vulnerability and clinical trials awareness and participation: A HINTS-SEER analysis.

The association between social vulnerability and clinical trials awareness and participation: A HINTS-SEER analysis.