Colorectal Cancer Screening, Hepatitis C Virus
Conditions
Keywords
Screening, HCV Screening, CRC Screening, Colorectal Cancer (CRC), Hepatitis C Virus (HCV)
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.
Interventions
BEHAVIORALMATCHES
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Florida Biomedical Research Program - Bankhead Coley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening Uptake for Hepatitis C Virus (HCV) and Colorectal Cancer (CRC) | Up to 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening Completion for Hepatitis C Virus (HCV) | Up to 41 Months | Screening Completion for HCV will be measured by the number of participants who complete HCV Screening at any time during the Study Period. |
| Screening Completion for Colorectal Cancer (CRC) | Up to 41 Months | Screening Completion for CRC will be measured by the number of participants who complete CRC Screening at any time during the Study Period. |
| Screening Test Results for Hepatitis C (HCV) | Up to 41 Months | Screening Test Results will be measured as abnormal vs normal |
| Screening Test Results for Colorectal Cancer (CRC) | Up to 41 Months | Screening Test Results will be measured as abnormal vs normal |
| Completion of repeat CRC Screening | Up to 41 Months | Completion of any repeat CRC Screening will be measured by the number of participants who repeat CRC Screening during the Study interval. |
Countries
United States
Contacts
CONTACTCarol Boxtha
CONTACTShannon Christy, PhD
PRINCIPAL_INVESTIGATORShannon Christy, PhD
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORClement K. Gwede, PhD, MPH, RN
Moffitt Cancer Center
Outcome results
None listed