Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening

NCT ID: NCT06745895

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2028-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Screening Hepatitis C Virus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

MATCHES

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florida Biomedical Research Program - Bankhead Coley

UNKNOWN

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shannon Christy, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Clement K. Gwede, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carol Boxtha

Role: CONTACT

Phone: 813-745-8963

Email: [email protected]

Shannon Christy, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carol Boxtha

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCC-23232

Identifier Type: -

Identifier Source: org_study_id