Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening

NCT06745895 | Recruiting

• 1 other identifier: MCC-23232
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Screening; Hepatitis C Virus

Keywords

Screening; HCV Screening; CRC Screening; Colorectal Cancer (CRC); Hepatitis C Virus (HCV)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Screening Completion for Hepatitis C Virus (HCV)

  Up to 41 Months

• Screening Completion for Colorectal Cancer (CRC)

  Up to 41 Months

• Screening Test Results for Hepatitis C (HCV)

  Up to 41 Months

• Screening Test Results for Colorectal Cancer (CRC)

  Up to 41 Months

• Completion of repeat CRC Screening

  Up to 41 Months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

MATCHES BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Florida Biomedical Research Program - Bankhead Coley: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Hepatitis C; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Shannon Christy, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Clement K. Gwede, PhD, MPH, RN

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Boxtha

CONTACT

813-745-8963; Carol.Boxtha@Moffitt.org

Shannon Christy, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible and enrolled patient participants enrolled in the intervention will receive a theory-informed educational booklet about both Colorectal Cancer (CRC) and Hepatitis C Virus (HCV) screening in English or Spanish, access to free stool-based CRC screening, and access to HCV screening. Implementation outcomes, facilitators, and barriers will be examined.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (1)