A randomized controlled trial of a multilingual digital genetic cancer risk assessment tool in a diverse patient population.

Abstract

10619 Background: Most individuals with hereditary cancer risk remain unidentified, particularly racial, ethnic, and linguistic minorities and those publicly insured. Patient-facing digital tools may improve personal/family history collection and genetic cancer risk assessment (GCRA). In this randomized controlled trial (RCT), we evaluated a multilingual digital GCRA tool in a diverse, predominantly publicly insured population. Methods: An IRB-approved RCT (NCT05562778) was conducted among new patients at four urban academic gynecology clinics. Eligible patients (≥ 18 years old, English-, Spanish-, Cantonese-, or Mandarin-speaking, no prior cancer genetic testing (GT)) were randomized to a digital GCRA tool versus usual care. The digital tool collected patient history and generated National Comprehensive Cancer Network (NCCN)-based GT eligibility reports for providers. Usual care relied on clinician assessment of personal/family history. The primary outcome was clinician identification of high-risk patients and recommendation for GT. Results: From 10/2023 to 10/2025, 210 patients enrolled in the study; 104 (50%) were randomized to GCRA via digital tool and 106 (50%) via clinician interview. Eighty (38%) patients self-identified as Hispanic, 39 (19%) non-Hispanic White, 40 (19%) non-Hispanic Black, and 51 (24%) Asian; 159 (76%) were English-speaking, 40 (19%) Spanish-speaking, and 11 (5%) Mandarin/Cantonese-speaking. Most were publicly insured (133, 63%), (Table 1). In the intervention arm, 99 (95%) completed the digital tool. Among all patients, 36 (17%) were identified as meeting NCCN criteria for high risk of hereditary cancer and thus eligible for GT (intervention: 14; control: 22). Use of the digital GCRA tool was associated with a higher likelihood of high-risk patients being identified and recommended GT (13 [93%] vs. 3 [14%]; P = < 0.001). Digital tool completion and high-risk identification did not differ by race, ethnicity, or language. Conclusions: In a diverse, predominantly publicly insured population, a multilingual digital GCRA tool increased identification and recommended GT for those at elevated risk for hereditary cancer. Integrating such tools may improve detection of at-risk individuals and reduce disparities in genetic service utilization. Clinical trial information: NCT05562778 . Participant characteristics. Characteristic Total Control Intervention Age in years (median, (IQR)) 45.5 (34-59) 46.5 (34-58) 43.4 (33.5-59) Race and Ethnicity (N (%)) Hispanic Non-Hispanic White Non-Hispanic Black Asian 80 (38%)39 (19%)40 (19%)51 (24%) 40 (38%)20 (19%)21 (20%)25 (24%) 40 (38%)19 (18%)19 (18%)26 (25%) Primary Insurance (N (%)) Public Private No Coverage/Other 133 (63%)46 (22%)31 (15%) 64 (60%)26 (25%)16 (15%) 69 (66%)20 (19%)15 (14%) IQR: interquartile range. Public: Medicaid, Medicare, or other government insurance. Private: employment-based or directly purchased.