Colorectal Cancer (CRC) ScreeningNCT07781774
Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
A study testing Colorectal Cancer Education Materials, Cologuard test kit and Fecal immunochemical test kit in people with Colorectal Cancer (CRC) Screening and CRC Screening, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a mixed-methods implementation pilot combining an educational intervention with a mailed stool-based testing outreach feasibility study within a resident primary care clinic. Participants will be assigned by clinic team to education, mailed FIT, mailed Cologuard, or usual care comparison groups. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC) Screening, CRC Screening, Rectal Cancer
- What is being tested?
- Colorectal Cancer Education Materials, Cologuard test kit and Fecal immunochemical test kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Phase 1 Education Arm Inclusion Criteria:
- Previously enrolled in prior study IRB #202202059 who agreed to participate in future research
Phase 1 Education Arm Exclusion Criteria:
- Not enrolled in prior study IRB #202202059
Phase 2 (All Other Arms) Inclusion Criteria:
- Primary Care Medicine Clinic patient (PRMC)
- Eligible for CRC screening
- Between age 45-75 years old
- Have eligible health insurance
Phase 2 (All Other Arms) Exclusion Criteria:
- Prior history of colorectal cancer
- Diagnosis of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
Cassandra Fritz, MD, MPHS, 314-454-8165, cfritz@wustl.edu
Darren Nix, 314-362-3201, nixd@wustl.edu
About this study
Official title: Improving Colorectal Cancer Screening Uptake Through Patient-Centered Education and Mailed Stool-Based Testing Outreach in the Primary Care Medicine Clinic
This is a mixed-methods implementation pilot combining an educational intervention with a mailed stool-based testing outreach feasibility study within a resident primary care clinic. Participants will be assigned by clinic team to education, mailed FIT, mailed Cologuard, or usual care comparison groups.
- Conditions
- Colorectal Cancer (CRC) Screening, CRC Screening, Rectal Cancer, Colon Cancer, Colorectal Cancer
- Being tested
- Colorectal Cancer Education Materials, Cologuard test kit, Fecal immunochemical test kit, Usual Care
- Keywords
- Colorectal cancer, Screening, Primary care, Teaching clinics
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal Cancer Education MaterialsBehavioural
Education materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope. The education materials are at a 6th grade reading level. Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes.
Cologuard test kitDiagnostic test
The Cologuard test will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
Fecal immunochemical test kitDiagnostic test
The Fecal immunochemical test (FIT) will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
Usual CareBehavioural
Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Participants will complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test prior to receiving education materials. After the pre-test, participants will be provided with ACCL education materials. Three months after being provided education materials, participants will repeat ACCL testing. Receives: Behavioral: Colorectal Cancer Education Materials |
| Mailed FIT | Experimental | Participants will receive a mailed package including 1 FIT test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart.
Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. Receives: Diagnostic Test: Fecal immunochemical test kit |
| Mailed Cologuard | Experimental | Participants will receive a mailed package including 1 Cologuard test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants will have 3 months to return the kit. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart.
Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. Receives: Diagnostic Test: Cologuard test kit |
| Usual Care | Active comparator | Participants will receive usual care from provider after enrollment with no intervention. Usual care includes providers offering standard screening options including FIT, Cologuard, and colonoscopy at the initial visit with no default option or structured follow-up. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRC knowledge (Education Arm only)
Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test. The ACCL consists of 10-items with True/False/Unsure. The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy.
Measured: At enrollment and 3 months after educational intervention (total estimated time is 3 months)
Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
Measured: At 3 months after receiving kit (total estimated time 3 months)
Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)
Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3). The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent. Generally, the higher the score indicates greater customer satisfaction.
Measured: At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
CRC screening completion rate (All arms)
CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
Measured: From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC) 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients are assigned to a resident primary care provider. Each resident is assigned to a team-based structure within the resident clinic, and there are 12 resident teams. Each team is composed of 12 residents, and each resident has a patient panel of \~100 patients. Participants will be recruited via resident patient panels and randomized 1:1:1 by resident clinic teams. The Education Arm will be drawn from patients who agreed to be recontacted from a prior study and will not be randomized.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cassandra Fritz, MD, MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781774
- Sponsor's protocol ID
- 202606027
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Colorectal Cancer Screening Uptake Through Patient-Centered Education and Mailed Stool-Based Testing Outreach in the Primary Care Medicine Clinic
- ClinicalTrials.gov ID
- NCT07781774
- Acronym / sponsor ID
- 202606027
- Conditions
- Colorectal Cancer (CRC) Screening, CRC Screening, Rectal Cancer, Colon Cancer, Colorectal Cancer
- Keywords
- Colorectal cancer, Screening, Primary care, Teaching clinics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a mixed-methods implementation pilot combining an educational intervention with a mailed stool-based testing outreach feasibility study within a resident primary care clinic. Participants will be assigned by clinic team to education, mailed FIT, mailed Cologuard, or usual care comparison groups.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All patients are assigned to a resident primary care provider. Each resident is assigned to a team-based structure within the resident clinic, and there are 12 resident teams. Each team is composed of 12 residents, and each resident has a patient panel of ~100 patients. Participants will be recruited via resident patient panels and randomized 1:1:1 by resident clinic teams. The Education Arm will be drawn from patients who agreed to be recontacted from a prior study and will not be randomized.
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Colorectal Cancer Education MaterialsParticipants will complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test prior to receiving education materials. After the pre-test, participants will be provided with ACCL education materials. Three months after being provided education materials, participants will repeat ACCL testing. |
| Mailed FIT | Experimental | Diagnostic Test: Fecal immunochemical test kitParticipants will receive a mailed package including 1 FIT test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. |
| Mailed Cologuard | Experimental | Diagnostic Test: Cologuard test kitParticipants will receive a mailed package including 1 Cologuard test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants will have 3 months to return the kit. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will receive usual care from provider after enrollment with no intervention. Usual care includes providers offering standard screening options including FIT, Cologuard, and colonoscopy at the initial visit with no default option or structured follow-up. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 Education MaterialsEducation materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope. The education materials are at a 6th grade reading level. Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes. | Behavioural | Education |
| Cologuard test kitThe Cologuard test will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided. | Diagnostic test | Mailed Cologuard |
| Fecal immunochemical test kitThe Fecal immunochemical test (FIT) will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided. | Diagnostic test | Mailed FIT |
| Usual CareUsual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic. | Behavioural | Usual Care |
Primary outcome
Change in CRC knowledge (Education Arm only)
Time frame: At enrollment and 3 months after educational intervention (total estimated time is 3 months)
Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test. The ACCL consists of 10-items with True/False/Unsure. The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy.
Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
Time frame: At 3 months after receiving kit (total estimated time 3 months)
Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)
Time frame: At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3). The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent. Generally, the higher the score indicates greater customer satisfaction.
CRC screening completion rate (All arms)
Time frame: From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cassandra Fritz, MD, MPHS 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 Education Materials, Cologuard test kit and Fecal immunochemical test kit in people with Colorectal Cancer (CRC) Screening and CRC 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?
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: opening soon, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassandra Fritz, MD, MPHS (314-454-8165, cfritz@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CRC knowledge (Education Arm only) (time frame: At enrollment and 3 months after educational intervention (total estimated time is 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.