Trial results comparing colorectal cancer screening outreach approaches were posted on ClinicalTrials.gov on 2025-12-26, indicating Cologuard demonstrated a risk difference of 4.7% (95% CI: 0.8-8.7) for higher screening completion rates compared to mailed FIT kits.
Background
Colorectal cancer (CRC) is a significant public health concern, with early detection through screening being crucial for improving outcomes. Disparities in screening rates persist, especially among racial and ethnic minority groups. Community health centers (CHCs) are vital in reaching underserved populations. This trial aimed to evaluate at-home screening outreach approaches—mailed Fecal Immunochemical Test (FIT) kits and Cologuard—to enhance CRC screening completion rates within CHCs and advance racial/ethnic equity.
Trial design
This pragmatic randomized clinical trial, with an enrollment of 5127 participants, compared two colorectal cancer screening outreach approaches. The study, which did not specify a phase, focused on patients overdue for CRC screening in community health centers. Participants were randomized to receive either a mailed Fecal Immunochemical Test (FIT) kit or Cologuard, to be completed at home. The main objectives were to compare screening test completion rates and assess feasibility and acceptability in a CHC setting.
Key results
The trial results provided key measurements and analyses regarding screening and diagnostic completion rates:
- For CRC Screening Completion Rates, one measurement showed 550 participants completed screening with the Mailed FIT Kit, while 751 completed with Cologuard. Another measurement reported 649 participants completed screening with Mailed FIT Kit, and 854 with Cologuard.
- Regarding Diagnostic Colonoscopy Completion Rates, 13 participants in the Mailed FIT Kit group completed the procedure, compared to 23 participants in the Cologuard group.
Key analyses revealed:
- A logistic regression analysis showed a Risk Difference (RD) of 4.7 (95.0% CI: 0.8 to 8.7) with a p-value of 0.05.
- Another logistic regression analysis indicated a Risk Difference (RD) of 4.5 (95.0% CI: 0.4 to 8.5) with a p-value of 0.05.
What this means
The findings suggest that Cologuard outreach may lead to higher colorectal cancer screening completion rates compared to mailed FIT kits in community health center settings. The observed risk differences of 4.7% and 4.5%, both with a p-value of 0.05, indicate a statistically significant advantage for Cologuard in encouraging screening participation. This could impact public health strategies aimed at improving early detection of colorectal cancer, particularly in underserved populations. Higher completion rates for diagnostic colonoscopy in the Cologuard group (23 vs. 13 participants for FIT) also suggest a potential benefit in completing the diagnostic pathway. These results support considering Cologuard as an effective option for improving CRC screening equity and outcomes.
Source
The information for this condition update was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05714644, titled "Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening", were posted on 2025-12-26 on clinicaltrials.gov.