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Colon Cancer Screening Toolkit for Colorectal Cancer

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
Screening 3 weeks
Treatment Varies
Follow Up completion of follow-up (estimated to be 44 months)
Awards & highlights
No Placebo-Only Group

Study 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.


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 Cancer Institute (NCI)NIH
13,579 Previous Clinical Trials
41,140,894 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,666 Previous Clinical Trials
6,611,106 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,920 Previous Clinical Trials
2,210,061 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be included in this trial?

"This clinical investigation is recruiting 83573 patients aged 45 to 75 with colon cancer who also have affiliation with Southern Illinois Healthcare's Physician Hospital Organization (PHO)."

Answered by AI

Does this research project still have openings for volunteers?

"Affirmative. According to clinicaltrials.gov, the trial which began recruiting patients on December 2nd 2020 is still in search of them. Currently 83573 participants need to be acquired from a single clinic site."

Answered by AI

Does this clinical trial accept participants aged sixty or older?

"The parameters for qualification dictate that enrollees should be between 45 and 75 years old."

Answered by AI

How many participants can register for this clinical experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this particular medical study is recruiting participants as of current date. The trial was initially presented on December 2nd 2020 and last updated June 30th 2022; it needs 83573 patients from one site alone for its completion."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~9728 spots leftby Jul 2024