Colon Cancer ScreeningNCT04651504

Rural Colon Cancer Screening Toolkit Intervention

A study testing Colorectal Cancer Toolkit in people with Colon Cancer Screening, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Colon Cancer Screening
What is being tested?: Colorectal Cancer Toolkit
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185,903 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2020to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare
Age 45-75 during the study period
Must be patient of the selected primary care clinic sites
Age 45-75 at the time of the health fair or screening event
Able to undergo stool testing as determined by SIH staff at the health fair or screening event

Who cannot join

Not a part of the PHO
Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
Employment at the relevant clinic at the time of the study
Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
Not employed at the relevant clinic at the time of the study
Younger than 45 years of age or older than 75 years of age during the study period

Show all 9Show fewer

Not a patient of the selected primary care clinic sites
Younger than 45 years of age or older than 75 years of age
Unable to undergo stool testing

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities

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.

Conditions: Colon Cancer Screening
Being tested: Colorectal Cancer Toolkit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colorectal Cancer ToolkitOther
The intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process.

Study groups in NCT04651504
Study group	Role	What they receive
Primary Care Clinics	Experimental	* 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. * At least 6 months of control data collection before clinics begin receiving the intervention. Receives: Other: Colorectal Cancer Toolkit

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test
- Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test.
- Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.
Measured: Within 60 days after receipt of positive FIT/FOBT
Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)
Measured: Within 60 days of referral to Gastroenterology

Secondary outcomes (3)

Time to Colonoscopy
Time between FIT date and colonoscopy.
Measured: Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 days
Proportion of Participants Who Initiate a Colonoscopy Within 14 Days of Positive Fecal Immunochemical Test
Measured: 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
Measured: Within 60 days after receipt of positive FIT/FOBT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202031 Dec 2024

First posted3 Dec 2020
Study start2 Dec 2020
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colon Cancer ScreeningStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Sequential
Model description: This is a stepped wedge trial where clusters of sites sequentially enter the intervention. Independent samples of patients are enrolled within a cluster at each set interval of time thus, it is analyzed as a repeated cross-sectional study.
Masking: None (open label)
Enrolment: 185,903 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04651504
Sponsor's protocol ID: 202010206
Other IDs: 5R01CA233848-02
Status last verified: Jul 2026
First submitted: 25 Nov 2020
Last updated: 5 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
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The PharmFIT Study
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Not yet recruiting
Life Expectancy-informed Colorectal Cancer Screening
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All Colon Cancer Screening trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities
ClinicalTrials.gov ID: NCT04651504
Acronym / sponsor ID: 202010206
Conditions: Colon Cancer Screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 185,903 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Study start: 2 Dec 2020 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 3 Dec 2020 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: This is a stepped wedge trial where clusters of sites sequentially enter the intervention. Independent samples of patients are enrolled within a cluster at each set interval of time thus, it is analyzed as a repeated cross-sectional study.

Arm	Type	Receives
Primary Care Clinics	Experimental	Other: 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. * At least 6 months of control data collection before clinics begin receiving the intervention.

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare
Age 45-75 during the study period
Must be patient of the selected primary care clinic sites
Age 45-75 at the time of the health fair or screening event
Able to undergo stool testing as determined by SIH staff at the health fair or screening event

Key exclusion criteria (9 listed)

Not a part of the PHO
Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
Employment at the relevant clinic at the time of the study
Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
Not employed at the relevant clinic at the time of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colorectal Cancer ToolkitThe intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process.	Other	Primary Care Clinics

Primary outcome

Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test
Time frame: Within 60 days after receipt of positive FIT/FOBT
* Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test. * Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.
Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)
Time frame: Within 60 days of referral to Gastroenterology

3 secondary outcomes

Time to Colonoscopy
Time frame: Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 days
Proportion of Participants Who Initiate a Colonoscopy Within 14 Days of Positive Fecal Immunochemical Test
Time frame: 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 frame: Within 60 days after receipt of positive FIT/FOBT

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Care Clinics Step Wedge 1: Control Portion Year 1, Intervention Portion Years 2-4	8,518	8,518
Primary Care Clinics Step Wedge 2: Control Portion Years 1-3, Intervention Portion Year 4	25,651	25,651
Primary Care Clinics Control Only Years 1-4	51,779	51,779

Primary outcome: Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test

Time frame: Within 60 days after receipt of positive FIT/FOBT. Count of participants. Unit: Participants

Measure	Primary Care Clinics n = 76134
Value	329

Population analysed: Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.

Primary outcome: Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)

Time frame: Within 60 days of referral to Gastroenterology. Number. Unit: colonoscopy completions

Measure	Primary Care Clinics Step Wedge 1 n = 139	Primary Care Clinics Step Wedge 2 n = 907	Primary Care Clinics Control Only n = 1235
Value	74	374	614

Population analysed: Over the study time period, individuals could receive \>1 FIT and thus can contribute more than 1 unit of data (instance of positive FIT followed by colonoscopy).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events, adverse events, and all-cause mortality were not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Primary Care Clinics Step Wedge 1	0 of 0	0 of 0
Primary Care Clinics Step Wedge 2	0 of 0	0 of 0
Primary Care Clinics Control Only	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Registry data come from EHR platforms, and may be incomplete, and data fields may vary across platforms. For this reason, registry data was not complete for all anticipated fields. Covid-19 caused delays in colonoscopy due to shutdowns and staff shortages. System-wide strategies were needed to address delays, hence we no longer expected an intervention effect on time to screening. Percentage of patients screened by any method is likely to be more reflective of intervention effects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Colon Cancer Screening

Active, not recruiting
Guardant Shield Colorectal Cancer Screening
Colorectal Cancer
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Not yet recruiting
The PharmFIT Study
Colorectal Cancer
Not yet recruiting
Life Expectancy-informed Colorectal Cancer Screening
Colorectal Cancer Control and Prevention
Enrolling by invitationObservational study
Protein Signature Based Screening of Colorectal Adenomas and Cancer
Colorectal Cancer, Colorectal Adenoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aimee James, Ph.D., MPH principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Colorectal Cancer Toolkit in people with Colon Cancer Screening, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test (time frame: Within 60 days after receipt of positive FIT/FOBT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04651504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.