Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)

Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C Virus; Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: MATCHES

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 Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol Boxtha; Phone Number: 813-745-8963; Email: Carol.Boxtha@Moffitt.org
• Study Contact Backup: Name: Shannon Christy, PhD

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Carol Boxtha; Phone Number: 813-745-8963; Email: Carol.Boxtha@Moffitt.org
      • Principal Investigator: Christy Shannon, PhD
      • Sub-Investigator: Clement K Gwede, PhD, MPH, RN
      • Sub-Investigator: Susan T Vadaparampil, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES); The MATCHES intervention includes three patient-level intervention strategies that will be rolled out in two waves. Patient-level strategies are: 1) a combined education booklet with information about CRC/CRC screening and HCV infections/liver cancer/HCV screening in English or Spanish, 2) access to free stool-based CRC screening, and 3) access to free HCV antibody testing.

Behavioral: MATCHES; Participants will be asked to complete a survey with specific topics including Hepatitis C (HCV) and Colorectal (CRC) knowledge and health beliefs, screening intentions and demographic characteristics. Participants will be provided with education intervention materials (for example, a booklet) either in-person or via mail, access to free stool-based CRC screening, and access to free HCV screening. Approximately 1-2 weeks after receiving the education materials, participants will be asked to complete a post-intervention survey about the same specific topics (for example, HCV and CRC knowledge, HCV and CRC health beliefs, HCV and CRC screening intentions, healthcare experiences, perceptions of the educational materials) over the phone with a trained study staff. Participants with a positive HCV screening and/or CRC screening result will be navigated to follow-up care as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC)	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.	Up to 12 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Florida Biomedical Research Program - Bankhead Coley
• Investigators: Principal Investigator: Shannon Christy, PhD, Moffitt Cancer Center; Principal Investigator: Clement K. Gwede, PhD, MPH, RN, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Screening; CRC Screening; Colorectal Cancer (CRC); Hepatitis C Virus (HCV); HCV Screening
• Additional Relevant MeSH Terms: Blood-Borne Infections; Neoplasms by Site; Neoplasms; Intestinal Diseases; Infections; RNA Virus Infections; Virus Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Colonic Diseases; Communicable Diseases; Flaviviridae Infections; Hepatitis A; Hepatitis; Colorectal Neoplasms; Hepatitis C
• Other Study ID Numbers: MCC-23232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No