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Colon Cancer Screening Toolkit for Colorectal Cancer

N/A
Recruiting
Led By Aimee James, Ph.D., MPH
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of follow-up (estimated to be 44 months)
Awards & highlights

Summary

This trial is testing a multilevel intervention to improve follow-up rates for positive fecal immunochemical tests (FITs), which are used to screen for colorectal cancer (CRC). The intervention is being implemented in a rural, underserved area in Southern Illinois.

Who is the study for?
This trial is for people in rural Southern Illinois who have had a positive fecal immunochemical test (FIT) for colorectal cancer and need to follow up with a colonoscopy. It's focused on primary care clinic sites affiliated with the Southern Illinois Healthcare Physician Hospital Organization.Check my eligibility
What is being tested?
The study is testing a 'Colorectal Cancer Toolkit' designed to improve follow-up rates after positive FIT results. The goal is to see if this toolkit helps more people get colonoscopies, which could lead to earlier detection of colorectal cancer in rural areas.See study design
What are the potential side effects?
Since this trial involves an organizational intervention rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience increased medical interactions or procedures as part of the enhanced follow-up process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of follow-up (estimated to be 44 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of follow-up (estimated to be 44 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of colonoscopy completions after positive fecal immunochemical test
Number of referrals for colonoscopies after positive fecal immunochemical test
Secondary outcome measures
Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test
Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test
Time to colonoscopy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Primary Care ClinicsExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,424,287 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,875,738 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,223,895 Total Patients Enrolled
2 Trials studying Colon Cancer Screening
1,290 Patients Enrolled for Colon Cancer Screening

Media Library

Colorectal Cancer Toolkit (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04651504 — N/A
Colon Cancer Screening Research Study Groups: Primary Care Clinics
Colon Cancer Screening Clinical Trial 2023: Colorectal Cancer Toolkit Highlights & Side Effects. Trial Name: NCT04651504 — N/A
Colorectal Cancer Toolkit (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04651504 — N/A
~18254 spots leftby Jul 2025
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