Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
19. august 2026 opdateret af: Washington University School of Medicine
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Darren Nix
- Telefonnummer: 314-362-3201
- E-mail: nixd@wustl.edu
Undersøgelse Kontakt Backup
- Navn: Cassandra Fritz, MD, MPHS
- Telefonnummer: 314-454-8165
- E-mail: cfritz@wustl.edu
Studiesteder
-
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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Kontakt:
- Darren Nix
- Telefonnummer: 314-362-3201
- E-mail: nixd@wustl.edu
-
Kontakt:
- Cassandra Fritz, MD, MPHS
- Telefonnummer: 314-454-8165
- E-mail: cfritz@wustl.edu
-
Underforsker:
- Kamilah Scales, MD
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Education
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.
|
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.
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Eksperimentel: Mailed FIT
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. |
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.
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Eksperimentel: Mailed Cologuard
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. |
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.
|
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Aktiv komparator: Usual Care
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.
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Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in CRC knowledge (Education Arm only)
Tidsramme: At enrollment and 3 months after educational intervention (total estimated time is 3 months)
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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.
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At enrollment and 3 months after educational intervention (total estimated time is 3 months)
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Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
Tidsramme: At 3 months after receiving kit (total estimated time 3 months)
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At 3 months after receiving kit (total estimated time 3 months)
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Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)
Tidsramme: At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
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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.
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At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
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CRC screening completion rate (All arms)
Tidsramme: From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
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CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
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From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Cassandra Fritz, MD, MPHS, Washington University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. september 2026
Primær færdiggørelse (Anslået)
31. marts 2029
Studieafslutning (Anslået)
31. marts 2029
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
24. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202606027
Plan for individuelle deltagerdata (IPD)
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Ja
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