Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
19. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Darren Nix
- Telefonnummer: 314-362-3201
- E-post: nixd@wustl.edu
Studer Kontakt Backup
- Navn: Cassandra Fritz, MD, MPHS
- Telefonnummer: 314-454-8165
- E-post: cfritz@wustl.edu
Studiesteder
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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Ta kontakt med:
- Darren Nix
- Telefonnummer: 314-362-3201
- E-post: nixd@wustl.edu
-
Ta kontakt med:
- Cassandra Fritz, MD, MPHS
- Telefonnummer: 314-454-8165
- E-post: cfritz@wustl.edu
-
Underetterforsker:
- Kamilah Scales, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Cassandra Fritz, MD, MPHS, Washington University School of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
31. mars 2029
Studiet fullført (Antatt)
31. mars 2029
Datoer for studieregistrering
Først innsendt
19. august 2026
Først innsendt som oppfylte QC-kriteriene
19. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202606027
Plan for individuelle deltakerdata (IPD)
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