Clinical Trial Enrollment Research Articles

Language as a barrier to clinical trial enrollment: Identifying methods to improve clinical trial enrollment in minority and non-English-speaking patients

Language as a barrier to clinical trial enrollment: Identifying methods to improve clinical trial enrollment in minority and non-English-speaking patients

Impact of geographic region on racial disparities in gynecologic oncology clinical trial enrollment

Impact of geographic region on racial disparities in gynecologic oncology clinical trial enrollment

Enrichment for clinical trials of early AD: Combining genetic risk factors and plasma p-tau as screening instruments.

Identifying low-cost, minimally-invasive screening instruments for Alzheimer's disease (AD) trial enrichment will improve the efficiency of AD trials. A total of 685 cognitively normal (CN) individuals and individuals with mild cognitive impairment (MCI) from the Alzheimer's Disease Neuroimaging Initiative (ADNI) were grouped according to cutoffs of genetic risk factor (G) polygenic hazard score (PHS) and tau pathology (T) plasma phosphorylated tau-181 (p-tau181) into four groups: G+T+, G-T-, G+T-, and G-T+. We assessed the associations between group level and longitudinal cognitive decline and AD conversion. Power analyses compared the estimated sample size required to detect differences in cognitive decline. The G+T+ group was associated with faster cognitive decline and higher AD risk. Clinical trials enrolling G+T+ participants would benefit from significantly reduced sample sizes compared with similar trials using only single makers as an inclusion criterion. The combination of two low-cost, minimally-invasive measures-genetics and plasma biomarkers-would be a promising screening procedure for clinical trial enrollment. Participants with unimpaired or mildly impaired cognition were grouped based on cutoffs on genetic risk factors (G: polygenic hazardous score [PHS]) and Alzheimer's pathology (T: baseline plasma phosphorylated tau-181 [p-tau181]). Participants with high PHSs and plasma p-tau181 levels (G+T+) were at risk of faster cognitive decline and AD progression. The combination of PHS and plasma p-tau181 could enhance clinical trial enrichment more effectively than using single biomarkers.

Standard HIPAA Authorization Forms Decreased Response Rates for a Multi-site Pragmatic Trial.

The Health Insurance Portability and Accountability Act (HIPAA) aims to safeguard patient information; however, complex legal language may lead to confusion and mistrust, and hinder enrollment in clinical trials. To evaluate the effect of a standard HIPAA authorization included in mailed survey packets on study enrollment for a multi-site pragmatic trial. This study is nested within an advance care planning pragmatic trial at 50 primary care clinics across three University of California (UC) Health Systems. We included English and Spanish-speaking seriously ill patients. One third of eligible patients received and 2/3 did not receive the HIPAA authorization in their enrollment packet. We compared enrollment rates at 3months and assessed the readability, understandability, and actionability of the standard HIPAA form using the Federal Plain Language Guidelines Checklist for Plain Language, the Automatic Readability Checker consensus calculator (grade 8 is the average reading level for US adults), and the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P, 0-100%, 70% considered the minimum). Of 4632 eligible patients (mean age 71, 48% women, 11% Spanish-speaking, 40% racial/ethnic minority); 1543 received a mailed enrollment packet with a HIPAA form and 3089 did not. Patients mailed the HIPAA form were less likely to enroll (10.2% vs. 14.8%, p < 0.001). The standard HIPAA form scored at the 12th grade reading level, had a PEMAT-P Understandability score of 42%, had an Actionability score of 40%, and only met 50% of Federal Plain Language Guideline Checklist items. The inclusion of a standard HIPAA authorization in mailed enrollment packets for a large pragmatic trial led to lower rates of study enrollment. This study informs how HIPAA authorization forms should be redesigned to be more accessible to patients to prevent unnecessary barriers to research enrollment.

Genetic Panel Reveals Coexisting Neuromuscular Disorders in Patients With Duchenne Muscular Dystrophy.

Duchenne muscular dystrophy is a genetically based neuromuscular disorder characterized by progressive physical impairment and cardiomyopathy in children, leading to fatal cardiac or respiratory failure. Duchenne muscular dystrophy shares some overlapping clinical features with other disorders, complicating clinical differentiation. We hypothesized that some Duchenne muscular dystrophy patients may have a secondary neuromuscular disorders that could negatively skew data during pharmaceutical clinical trials and lead to incomplete treatment plans. Consecutive genetic panels on 353 patients were reviewed. Thirty-two (32; 9.1%) patients with Duchenne muscular dystrophy were identified. Three (3; 9.4%) were found to have at least 1 genetically confirmed secondary neuromuscular disorder. Overlooking these coexisting disorders could lead to unexpected treatment failures, potentially affecting medication efficacy in trials or commercial use. Secondary neuromuscular disorders should be considered in Duchenne muscular dystrophy patients before clinical trial enrollment or treatment planning, with expanded genetic testing, such as whole exome sequencing or whole genome sequencing, likely to reveal even more secondary disorders.

The Diagnostic Challenges of Late-onset Neuropsychiatric Symptoms and Early-onset Dementia: A Clinical and Neuropathological Case Study

The emergence of new-onset neuropsychiatric symptoms in middle age presents a diagnostic challenge, particularly when differentiating between a primary psychiatric disorder and an early neurodegenerative disease. The discrepancy between bedside clinical diagnosis and subsequent neuropathological findings in such cases further highlights the difficulty of accurately predicting pathology, especially when there are no evident focal lesions or changes in brain volume. Here we present the case of a 59-year-old woman with inconclusive neuroimaging who exhibited pronounced neuropsychiatric and behavioral symptoms initially suggestive of a mood disorder, then of behavioral variant frontotemporal dementia. However, upon autopsy, we identified coexisting Lewy body disease pathology and tau-related changes, including argyrophilic grain disease and primary age–related tauopathy. This case illustrates the challenges encountered when diagnosing late-onset neuropsychiatric symptoms, emphasizes the link between such symptoms and early-onset dementia and argyrophilic grain disease, and contributes to our understanding of the impact of mixed neuropathology in this population. Accurate diagnosis is essential for the development of molecular-specific therapies and, as well as for accurate prognosis and enrollment in clinical trials.

Two-stage group-sequential designs with delayed responses – what is the point of applying corresponding methods?

BackgroundIn group-sequential designs, it is typically assumed that there is no time gap between patient enrollment and outcome measurement in clinical trials. However, in practice, there is usually a lag between the two time points. This can affect the statistical analysis of the data, especially in trials with interim analyses. One approach to address delayed responses has been introduced by Hampson and Jennison (J R Stat Soc Ser B Stat Methodol 75:3-54, 2013), who proposed the use of error-spending stopping boundaries for patient enrollment, followed by critical values to reject the null hypothesis if the stopping boundaries are crossed beforehand. Regarding the choice of a trial design, it is important to consider the efficiency of trial designs, e.g. in terms of the probability of trial success (power) and required resources (sample size and time).MethodsThis article aims to shed more light on the performance comparison of group sequential clinical trial designs that account for delayed responses and designs that do not. Suitable performance measures are described and designs are evaluated using the R package rpact. By doing so, we provide insight into global performance measures, discuss the applicability of conditional performance characteristics, and finally whether performance gain justifies the use of complex trial designs that incorporate delayed responses.ResultsWe investigated how the delayed response group sequential test (DR-GSD) design proposed by Hampson and Jennison (J R Stat Soc Ser B Stat Methodol 75:3-54, 2013) can be extended to include nonbinding lower recruitment stopping boundaries, illustrating that their original design framework can accommodate both binding and nonbinding rules when additional constraints are imposed. Our findings indicate that the performance enhancements from methods incorporating delayed responses heavily rely on the sample size at interim and the volume of data in the pipeline, with overall performance gains being limited.ConclusionThis research extends existing literature on group-sequential designs by offering insights into differences in performance. We conclude that, given the overall marginal differences, discussions regarding appropriate trial designs can pivot towards practical considerations of operational feasibility.

Diversity in U.S. Clinical Trials for Head and Neck Cancer: Are We Improving?

This study assesses whether national initiatives undertaken to improve diversity in clinical trial enrollment have been successful within head and neck cancer (HNC) trials. A retrospective analysis was conducted of HNC trials published on clinicaltrials.gov with start dates between 2000 and 2023. Demographic data for 8998 HNC trial enrollees was abstracted and analyzed to investigate potential demographic shifts. In the past 20 years, the percentage of White patients increased 6.1%, Asian patient population decreased 3.1%, and Black patient population increased 0.8%. Compared with previously published SEER data, HNC trials have significantly more White patients, fewer Black patients, and fewer Asian/Native-Hawaiian patients than HNC patients at large. Despite efforts to increase diversity in HNC clinical trials in the United States, diversity has significantly decreased in the past 10 years. As current approaches are failing to show improvement, novel approaches to improving representation in clinical trials are necessitated.

Blue-button: A tool for institution-agnostic, EHR-integrated regional clinical trial matching.

65 Background: Research indicates that most people with cancer are willing to enroll in clinical trials when offered the chance, but only 7% actually participate in cancer treatment trials. Barriers to screening and enrollment include time and effort for providers to screen patients for trials, and lack of awareness of available regional trials. Stakeholders recommended creation of free, automated screening tools and processes integrated into provider workflows, directly interfacing with site electronic health records (EHRs), that would search for regional trial eligibility. The need for such tools was independently identified in a large national survey of oncology providers. Methods: The Blue-button tool was developed to automatically identify relevant, regional clinical trials. A collaboration between ACS CAN and MITRE, a not-for-profit organization working in the public interest, created the tool’s functionality. Clinical workflow and research protocol were developed in collaboration with University of Texas Southwestern Simmons Comprehensive Cancer Center. This SMART-on-FHIR application works within existing EHR systems by automatically extracting and sending limited, deidentified patient data elements to third-party trial matching services via the FHIR mCODE standard, a core set of non-proprietary, open-source structured data elements that establishes minimum standards for the structure and content of oncology data in health records. Potential trial matches within a specified radius of the practice are returned in a standard format using the FHIR Research Study resource. Results: Blue-button extracts limited patient data from EHR and provides it in an interface allowing users to update data before sending to trial matching services. Only non-identifiable information is sent to the external clinical trial matching services, which then return prescreen trial matches for manual review to confirm patient eligibility. Thus, with a few clicks in a medical record, the tool quickly identifies comprehensive trial availability within a specified distance of the patient’s location. When used by providers, Blue-button reduces the manual burden that often prevents consideration of clinical trials and identifies regional opportunities beyond the treating institution. Conclusions: Successful feasibility testing demonstrated the effectiveness of automated regional trial screening as a model. We have launched a clinical trial at two sites to assess the effectiveness of the Blue-button tool with patients in healthcare settings. We expect patient enrollment to continue through part or all of 2025. This trial of the Blue-button tool will provide additional information on provider accessibility and uptake and will demonstrate whether EHR-integrated regional trial screening leads to increased opportunities and enrollment in cancer clinical trials. Clinical trial information: NCT05885880 .

Talk to Me: A social media campaign about clinical trials tailored to the needs of young adults with cancer.

67 Background: Among adolescents and young adults (AYAs; 15-39 years) with cancer, clinical trial enrollment (CTE) rates range from 3% to 14%. Patient-directed interventions to improve CTE are rare. Internet-based interventions, while feasible and acceptable to AYAs with cancer, often lack patient input and engagement that are critical to success. AYAs are digital natives and report that the internet and social media are the two most important sources of health-related information. We leveraged AYA engagement with social media and designed a mixed methods research study, "Talk to Me," to create targeted social media messages to increase awareness about CTE for AYAs with cancer. Methods: Our interdisciplinary study team includes clinicians, researchers, health educators, and AYA patient advocates. We conducted 5 focus groups among a demographically, clinically, and geographically diverse group of AYAs with cancer (n=35) to identify priority topics to 1) inform the development of social media message libraries to address informational gaps and dispel myths surrounding CTE and 2) guide implementation strategies of these messages. Design mock-ups and color palettes were co-designed and co-developed with focus group participants and patient advocates through iterative feedback. Results: Guided by qualitative findings, social media posts were categorized into "introduction", "knowledge dissemination", and "addressing social, cultural, emotional, and financial issues" related to CTE. Instagram was selected to host our messages as the demographics of users most closely matched that of our target audience. Hashtags were carefully chosen based on existing posts of related material on Instagram. Links to trusted sources for additional information were embedded in the post descriptions and housed in a linktr.ee bio-landing page. The campaign was officially launched on Instagram in April 2024. We posted 3 times a week in both English and Spanish and monitored metrics biweekly to assess engagement and reach. Over nearly 2 months, 42 messages were posted, 116 users followed the account, 656 accounts were reached, 108 accounts were engaged, and 432 visited our profile page. Engagement peaked in Week 2 with 238 accounts reached and in Week 6 with 119. Overall, there were 173 likes (English=128, Spanish=43). Conclusions: An interdisciplinary, patient-informed, iterative approach to developing a social media knowledge intervention demonstrates a robust, methodologic approach to developing acceptable information and messages for AYAs who may consider participating in clinical trials.

Influence of an AYA cancer program on cancer care delivery.

4 Background: Adolescent and young adults (AYAs, aged 13-39) with cancer face barriers to care and stagnant survival outcomes. The University of North Carolina (UNC) at Chapel Hill's AYA Cancer Program, established in 2015, aims to address these challenges. The program operates through both consultations and targeted outreach based on patient risk-stratification, offering services such as fertility counseling, enhanced access to clinical trial enrollment, a dedicated sarcoma palliative care collaborative, survivorship clinic, and psychosocial support. AYA program providers work with patients to create tailored care plans that meet AYAs' psychosocial and medical needs. To better understand the reach and impact of this novel care delivery approach, we performed a retrospective cohort study over the 8-year period of program development. Methods: Using linked electronic health record (EHR) and State Cancer Registry data, we performed a retrospective cohort study of AYA patients at UNC from 2014-2022, comparing sociodemographic and clinical criteria between those with and without AYA Cancer Program contact. Our analysis included outcomes of care utilization, complications, and supportive care measures. Using SMR propensity weighting with multivariable log binomial modeling, we evaluated associations between outcomes and AYA program contact. Factors such as age at diagnosis, race, sex, insurance status, cancer site, metastatic disease, and receipt of systemic therapy were considered in the weighting scheme. Results: Of 4,016 AYAs receiving cancer care at UNC, 670 had contact with our program. Program-engaged patients were younger at diagnosis, more likely to be Black, and had higher rates of metastatic disease or hematologic malignancies. In weighted model analyses, program patients were more likely to receive guideline recommended care, including enrollment in a clinical trial, receipt of fertility counseling and palliative care, and documented advanced care planning. Over time, our program's reach expanded from 6% to more than 25% of the total AYA population. Conclusions: Our findings indicate that AYAs contacted by our program through a consult-based, targeted outreach model represent a distinct population with higher clinical needs. Despite this complexity, they were more likely to receive guideline-recommended care, including clinical trial enrollment, fertility counseling, and palliative care. Care delivery outcomes by program contact. No Program Contact (n= 3346) Program Contact (n=670) Clinical Trial Enrollment 882 (26.4%) 301 (44.9%) 1.31 (1.14, 1.49) Fertility Counseling 77 (2.3%) 119 (17.8%) 2.09 (1.56, 2.80) Palliative Care 102 (3.0%) 125 (18.7%) 3.46 (2.44, 4.91) Advanced Care Planning 176 (5.3%) 91 (13.6%) 1.55 (1.14, 2.11)

Treatments for Patients with Metastatic Castration-resistant Prostate Cancer Who Previously Received Triplet Therapy at the Metastatic Hormone-sensitive Stage

The level of evidence for the management of prostate cancer progressing after triplet therapy is currently low. Molecular profiling of patients and enrolment in clinical trials are strongly recommended.

Racial representation in multicenter clinical trials leading to drug approvals for gynecological cancer indications by the US Food and Drug Administration (FDA).

66 Background: Enrollment disparities in gynecologic (Gyn) cancer clinical trials in the United States (US) are well-documented. However, there is limited data evaluating how recruitment sites in international clinical trials contribute to racial representation, specifically in Gyn cancers. Here, we examined racial enrollment and geographic location in clinical trials that have led to approval for Gyn cancer applications. Methods: Agents approved by the FDA for Gyn cancer treatment and corresponding clinical trials were identified from the FDA Drug Approvals and Databases. Enrollment data were abstracted from ClinicalTrials.gov then cross-checked with published manuscripts and FDA labels. Using Gyn disease site prevalence from the 2021 SEER database, we calculated expected enrollment proportions by race and compared these to actual clinical trial enrollment data. The binomial test was used to compare expected vs. observed proportions with White patients as the reference group. Results: From 2014 to 2024, 9 drugs received 22 FDA approvals for ovarian (n=13), endometrial (n=4), or cervical cancer (n=5). These approvals were based on 28 clinical trials enrolling a total of 13,763 patients (75.7% White, 3.4% Black, 12.0% Asian, 8.9% Other/Unknown). These trials included 1 (3.6%) US only study, 3 (10.7%) non-US, primarily Europe-based studies (PAOLA-1, AURELIA, STUDY42 [Europe + Australia]), and 24 (85.7%) international studies across the US and 46 other countries. Considering the distribution of race (White: 86.3%, Black: 8.4%, Asian: 4.9%) of Gyn cancers in the US, Black patients had lower enrollment (45% of expected enrollment) vs. White patients (95% of expected enrollment, P&lt;0.0001). African countries were rarely included among the recruitment sites. Two international trials reported patient recruitment from South Africa (3.2% Black, 6/188 patients, 38% of expected enrollment).However, Asian patients had higher enrollment (269% of expected enrollment, P&lt;0.0001) compared to White patients. In 13 trials that included study sites in East Asia, Asian patients comprised 16% of the trial population (1310/8205 patients; 327% of expected enrollment) vs. 3.2% in trials that did not open in Asia (n=15) (181/5558 patients; 67% of expected enrollment). Conclusions: Black patients were underrepresented in pivotal trials that led to FDA approvals for Gyn cancers. Overrepresentation of Asian patients was likely due to international enrollment from East Asia. Post-marketing retrospective studies or additional studies focused on underrepresented groups are needed to assess true drug efficacy and safety in US populations that are disproportionately affected by Gyn cancer mortality.

Gender differences in spine surgery for degenerative lumbar disease: prospective cohort study.

Despite efforts toward achieving gender-based equality in clinical trial enrollment, females are frequently underrepresented and gender-specific data analysis is lacking. Identifying and addressing gender bias in medical decision-making and outcome reporting may facilitate more equitable healthcare delivery. This study aimed to determine if gender differences exist in the clinical evaluation and surgical management of patients with degenerative lumbar conditions. Consecutive adult patients undergoing spinal surgery for degenerative lumbar conditions (disc herniation [DH], spinal canal stenosis [SCS], and degenerative spondylolisthesis [DS]) were prospectively enrolled across 16 tertiary academic centers. Outcome domains included pain, disability, health-related quality of life (HRQOL), expectations of surgery, and satisfaction with surgical outcome. Covariates pertaining to the preoperative use of healthcare resources, diagnostic testing, and visits to healthcare providers were compared between genders before and after propensity score matching for 13 baseline demographic and procedural variables. Data were analyzed for 5038 patients (2396 female, 2642 male) with degenerative spinal pathologies including SCS (40.2%), DS (33.2%), and DH (26.6%). Surgical treatment effect was similar for both genders. For all conditions, female patients had worse pre- and postoperative pain, disability, and HRQOL. Significant gender differences were identified for marital status, education, employment status, exercise activities, and disability claims. Female patients were more likely to use select medications, diagnostic imaging tests, and nonsurgical therapeutic interventions, and access various healthcare providers. Findings were similar following post hoc propensity score matching. In this multicenter, prospective, observational cohort study, male and female patients benefitted similarly from surgery for degenerative lumbar spine disease. However, female patients had worse preoperative clinical assessment scores and were more likely to use select healthcare resources.

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.

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.

P4.17C.01 Clinical Trial Enrollment at a Thoracic Oncology Program at a Single-Academic Institution Serving Primarily Underrepresented Patients

P4.17C.01 Clinical Trial Enrollment at a Thoracic Oncology Program at a Single-Academic Institution Serving Primarily Underrepresented Patients

P2.16A.01 Actionable Alterations Identification in NSCLC by Comprehensive Genomic Profiling for Clinical Trial Enrollment: EPROPA

P2.16A.01 Actionable Alterations Identification in NSCLC by Comprehensive Genomic Profiling for Clinical Trial Enrollment: EPROPA

Patient interest in clinical trials and remote technology among a diverse oncology patient population.

389 Background: Existing research describes a number of barriers limiting cancer clinical trial enrollment, including time constraints and financial burden, particularly among under-represented populations. In this study, we sought to assess the relationship between the use of remote technology in clinical trials and patient interest in trial participation amongst oncology patients at an urban academic medical center. Methods: We administered a 60-question, cross-sectional, in-person survey to adult patients with a solid tumor or hematological malignancy diagnosis on active treatment at Columbia University Irving Medical Center between 1/2023 and 2/2024. The survey assessed patient demographics, telehealth access, and interest in using telehealth as part of routine care and clinical trials. Demographics including age, gender, race/ethnicity, marital status, income, insurance type, education level, and cancer type were self-reported. Results: The survey was administered to 100 oncology patients. The mean age was 61 years; 51% were female; 45% non-White and 23% identified as Hispanic. The majority (87%) reported having access to a computer or electronic device; 99% of those having internet access and 81% being somewhat or very comfortable using the internet. Forty seven percent of patients had been offered a cancer clinical trial by their oncology provider, and 19% had participated or were currently participating in a clinical trial. Of the 53% of patients who had not been offered a clinical trial or did not know, 64% reported they would consider participating in a trial recommended by their oncologist. Among all respondents, 52% of patients reported it would make no difference in their decision to participate in a trial if they learned about the risks and benefits remotely (phone or video), 28% were somewhat more or much more likely to participate learning about the risks and benefits remotely, and 20% were somewhat less or much less likely to participate under these conditions. Seventy five percent of respondents would be willing to sign consent for a trial remotely. Sixty four percent of respondents were not willing to spend over an hour traveling to a trial site, citing time, cost, family, and work obligations as reasons for limiting travel. The majority of respondents (&gt;50%) indicated that they would be more likely to participate if the trial used remote technology to decrease the need to travel to a trial site. Conclusions: In this cross-sectional study amongst a diverse patient population, we found that the majority of oncology patients on active treatment have access to telehealth, express interest in clinical trials despite barriers to participation, and would be more likely to enroll in trials if remote communication reduced the amount of travel time for trial participation. Decreasing the logistical burden of cancer clinical trials may increase patient access and diversity in trial participation.

Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement.

This study evaluates the effectiveness of the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program on enhancing referrals of underrepresented patients to lupus clinical trials. TIMELY leverages two existing American College of Rheumatology online educational initiatives: Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a continuing medical education activity for health care providers, and the community health worker (CHW) Lupus Clinical Trials Training (LuCTT). TIMELY introduced a unique roundtable meeting format to build on the existing online educational programs and facilitate discussions between local clinical trial sites and provider and CHW participants. This study used an online pretest and posttest design to assess changes in theory-based behavioral predictors of lupus clinical trial referrals and engagement (ie, knowledge, attitudes, self-efficacy, and intentions) among providers and CHWs. Participants completed MIMICT or LuCTT and then were eligible to participate in roundtable meetings. Paired t-tests were used to assess changes in composite scores before and after the intervention for each of the outcomes. The final sample included 40 providers and 18 CHWs. Knowledge scores increased significantly for both providers (P < 0.01) and CHWs (P < 0.001) on completion of MIMICT and LuCTT, respectively. After participating in the TIMELY roundtable, providers' composite scores for self-efficacy and intentions significantly increased (P < 0.001). Provider self-efficacy gains were sustained at three months' follow-up (P < 0.001). These promising findings highlight the potential and opportunities for the TIMELY program to improve behavioral predictors of trial referrals, including CHW knowledge and providers' knowledge, self-efficacy, and intentions to refer underrepresented patients to lupus clinical trials.