Recruiting

Colorectal Cancer & Hepatitis C

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06745895

Conditions

Colorectal Cancer Screening

Hepatitis C Virus

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

MATCHES

Study Details

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

Study ID

NCT06745895

Start date

Oct 21, 2024

Status verified date

Dec, 2024

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Enrollment

350 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC) [ Time Frame: Up to 12 Months ]

Central Contacts and Locations

Central contacts

Carol Boxtha

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

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Carol Boxtha

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

Principal Investigator:

Christy Shannon, PhD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Dec 20, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2024-12-20.