Rural Colon Cancer Screening Toolkit Intervention

Not Applicable

Recruiting

• Conditions: Colon Cancer Screening

• Registration Number: NCT04651504
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Study Start: 2020-12-02
• Study First Posted: 2020-12-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-28
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 285841

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of colonoscopy completions after positive fecal immunochemical test	Completion of follow-up (estimated to be 44 months)	-Within 60 days of referral
Number of referrals for colonoscopies after positive fecal immunochemical test	Completion of follow-up (estimated to be 44 months)

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test	Completion of follow-up (estimated to be 44 months)
Time to colonoscopy	Completion of follow-up (estimated to be 44 months)
Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test	Completion of follow-up (estimated to be 44 months)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States