Clinical trial NCT06745895: Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening
Official title: Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer Screening
Hepatitis C Virus
Keywords: Screening
HCV Screening
CRC Screening
Colorectal Cancer (CRC)
Hepatitis C Virus (HCV)
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Biomedical Research Program - Bankhead Coley
First posted: 2024-12-20
Enrollment: 350
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC)
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Screening Completion for Hepatitis C Virus (HCV)
timeFrame: Up to 41 Months
measure: Screening Completion for Colorectal Cancer (CRC)
timeFrame: Up to 41 Months
measure: Screening Test Results for Hepatitis C (HCV)
timeFrame: Up to 41 Months
measure: Screening Test Results for Colorectal Cancer (CRC)
timeFrame: Up to 41 Months
measure: Completion of repeat CRC Screening
timeFrame: Up to 41 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Shannon Christy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Clement K. Gwede, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: