NCT05375643

SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Nadine McCleary, MD, MPH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SURGE aims to increase equity in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.

Detailed description

Supporting UnderRepresented populations in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.

Conditions

• Gastrointestinal Cancer
• Hematologic Cancer
• Thoracic Cancer

Interventions

Type	Name	Description
BEHAVIORAL	SURGE	Video with or without person to person guidance to support decision making around genetic testing

Timeline

• Start date: 2023-04-03
• Primary completion: 2027-12-30
• Completion: 2028-07-30
• First posted: 2022-05-16
• Last updated: 2025-11-05

Locations

3 sites across 1 country: United States