Rural Colon Cancer Screening Toolkit Intervention

Not Applicable

Recruiting

• Conditions: Colon Cancer Screening
• Interventions: Other: Colorectal Cancer Toolkit

• 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: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83663

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Primary Care Clinics	Colorectal Cancer Toolkit	* Southern Illinois Healthcare System will contact the site management and ask for participation in the study * Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.

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