KEY TAKEAWAYS
- U-Screen is an observational study examining patient compliance with CRC screening by providing blood-based screening tests as an option to those who still need to complete a stool-based screening or colonoscopy within six months at three FQHCs.
- A stepped wedge cluster trial can assess the impact of a blood-based CRC screening test in FQHCs. The study will collect quarterly data to measure the feasibility, acceptability, and number of participants who otherwise would not have participated in the screening.
- The study will also offer a blood-based CRC screening test at no cost to patients who fail to complete CRC screening after 6 months.
- The study concluded the significance of blood tests for patients who don’t complete CRC screening.
The COVID-19 pandemic disrupted healthcare utilization, leading to declining CRC screening rates. This presents an opportunity for innovative approaches like blood-based CRC screening tests at point-of-care, which may improve compliance. FQHCs are vital in enhancing CRC outcomes and promoting health equity, especially for vulnerable populations with poor screening adherence. To improve patient compliance, this study will conduct a blood-based CRC screening test on patients who fail to complete stool-based or colonoscopy screening at 3 FQHCs.
The study will use a stepped wedge cluster trial design with an initial no-exposure period. Each FQHC will have 10 to 17 primary care clinics. Two FQHCs will first implement a blood-based CRC screening test, followed by another nine months later. Quarterly data assessed impact, feasibility, and acceptability. The primary endpoint is the number of participants not previously screened. The study will recruit patients aged 45-75 at average CRC risk, willing to provide informed consent and a blood sample. The blood-based CRC screening will be offered at no cost through a CLIA-certified laboratory (Guardant Health, CA). Up to 2,400 patients will be enrolled over three years.
The study concluded that patients often need to complete CRC screening, and a blood-based test may be more acceptable.
Source: https://meetings.asco.org/abstracts-presentations/225976
Clinical Trial: https://clinicaltrials.gov/study/NCT05536713
Karen Kim, David Liebovitz, Blase Polite, Fornessa Randal, and Helen Lam
Journal of Clinical Oncology 2023 41:16_suppl, TPS6654-TPS6654
