Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening

Not Applicable

Recruiting

• Conditions: Colorectal Cancer Screening; Hepatitis C Virus

• Registration Number: NCT06745895
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

This innovative Multilevel Action Toward Colorectal Cancer (CRC) and Hepatitis C Virus (HCV) Education and Screening (MATCHES) intervention aims to promote concurrent HCV and CRC screening among FQHC patients ages 45-75.

Detailed Description

While this is a multi-level intervention study, only information related to the patient-level intervention is being reported for the purposes ClinicalTrials.gov.

Study Timeline

• Study Start: 2024-10-21
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-10
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Participants must be receiving care at one of the participating FQHC clinics.
• Participants must be 45-75 years of age.
• Participants must not be up to date with Colorectal Cancer (CRC) screening recommendations such as no colonoscopy in the past 10 years, occult blood test in the past 12 months.
• Participants must never have had Hepatitis C Virus (HCV) antibody screening.
• Participants must be able to read, write, and understand English or Spanish.
• Participants must have no personal history of CRC or current presumptive CRC symptoms such as unresolved rectal bleeding or abdominal pain/bloating.
• Participants must be at average risk for CRC (no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC).
• Participants must be asymptomatic for HCV.
• Participants receiving intervention materials must be able and willing to complete surveys and receive the patient level intervention.
• Participants completing qualitative interviews must be willing to complete a remote interview via phone or teleconference software such as ZOOM.
• Participants completing qualitative interviews must be willing to be audio recorded.
• Participants recruited for qualitative interviews only (did not receive MATCHES intervention materials) must have a clinic visit within prior two months.
• All Participants must be able to provide informed consent.

Exclusion Criteria

• Participants that do not meet all Inclusion Eligibility requirements will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC)	Up to 12 Months	Screening Uptake will be measured by the number of participants who complete both CRC and HCV screening documented via Electronic Health Record (EHR) at 12 months post-intervention.

Secondary Outcome Measures

Name	Time	Method
Screening Completion for Hepatitis C Virus (HCV)	Up to 41 Months	Screening Completion for HCV will be measured by the number of participants who complete HCV Screening at any time during the Study Period.
Screening Completion for Colorectal Cancer (CRC)	Up to 41 Months	Screening Completion for CRC will be measured by the number of participants who complete CRC Screening at any time during the Study Period.
Screening Test Results for Hepatitis C (HCV)	Up to 41 Months	Screening Test Results will be measured as abnormal vs normal
Screening Test Results for Colorectal Cancer (CRC)	Up to 41 Months	Screening Test Results will be measured as abnormal vs normal
Completion of repeat CRC Screening	Up to 41 Months	Completion of any repeat CRC Screening will be measured by the number of participants who repeat CRC Screening during the Study interval.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States