71Educational video intervention to enhance latinx participation in genitourinary oncology clinical trials: a randomized study

Abstract Background The Hispanic and Latinx population comprises over 60 million individuals in the United States, representing approximately 18 percent of the total population. Cancer is the leading cause of death in this group. Despite the disease burden, Latinx individuals remain underrepresented in cancer clinical trials, accounting for only 2.3 to 3.9 percent of participants in therapeutic studies. This disparity limits the applicability of research findings and contributes to inequities in outcomes. Barriers such as limited awareness, language discordance, mistrust in the medical system, and structural inequities impact participation. Culturally tailored educational interventions may help address these gaps. This investigator-initiated trial aims to investigate whether a brief, bilingual educational video can improve willingness to participate in clinical trials among Latinx adults diagnosed with genitourinary (GU) malignancies. Methods This is investigator-initiated, randomized, controlled, multi-center trial conducted. Eligible participants are adults aged 18 or older with a histologically confirmed diagnosis of a GU malignancy, including prostate, bladder, kidney, testicular, or penile cancer, or with tumor markers consistent with metastatic germ cell neoplasia. All participants must speak either English or Spanish and be attending their first consultation in Medical Oncology, Radiation Oncology, or Urology. Patients are randomized in a 1 to 1 ratio to either the experimental or control arm (Figure 1). Randomization is stratified by cancer type (prostate versus non-prostate) and language preference (English versus Spanish) to ensure balance across key variables. In the experimental arm, participants watch a 10-minute culturally adapted video in their preferred language. The video was developed in collaboration with clinicians, patient advocates, and community partners. It explains the purpose, risks, and benefits of clinical trials, emphasizes ethical protections, and highlights the importance of Latinx representation in research. Immediately afterward, participants complete the 31-item Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) questionnaire. This validated tool assesses willingness to participate in trials and explores attitudes across six domains, including fear, mistrust, privacy concerns, and knowledge gaps. In the control arm, participants complete the AIET questionnaire without viewing the video. After the survey, they are offered the opportunity to watch the video to ensure equitable access to educational content. The primary endpoint is the proportion of Latinx participants who express willingness to participate in a clinical trial, based on responses to item 31 of the AIET questionnaire. Based on prior data, a baseline willingness of 15 percent is assumed. The study is powered to detect an increase to 35 percent with a sample size of 110 participants (55 per arm), using a one-sided alpha of 0.1 and 80 percent power. Secondary endpoints include the proportion of Latinx participants who enroll in a clinical trial within six months of the intervention and changes in AIET subscale scores that reflect trust, perceived fairness, and understanding of clinical research. Additional questions assess general clinical trial literacy. Exploratory analyses will examine the same outcomes in non-Latinx participants. Statistical comparisons will be made using Fisher’s exact test and Wilcoxon rank-sum tests. Proportions will be reported with exact 95 percent confidence intervals. Significance & Vision The study is currently open to enrollment and is designed to inform scalable, culturally responsive strategies to improve equity in clinical trial participation for Latinx patients with cancer. Trial Schema