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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04980157
Other study ID # MCC-20601
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2022

Study information

Verified date January 2023
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 56 Years to 75 Years
Eligibility Inclusion Criteria: - Born between 1945 and 1965 and up to age 75 - No personal history of colorectal cancer (CRC) or current presumptive colorectal cancer symptoms (e.g., unresolved rectal bleeding or abdominal pain/bloating) - No personal history of hepatitis C virus (HCV) or liver cancer - Able to read, write, speak, and understand English or Spanish - Not currently enrolled in another CRC screening or a HCV screening study - At average risk for CRC (that is, no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC) - Not currently up-to date with CRC screenings - Not having previously completed HCV screening - Able and willing to complete a phone interview - Able to provide informed consent

Study Design


Intervention

Behavioral:
CARES-HCV
CARES-HCV is an educational intervention to promote both hepatitis c screening and colorectal cancer screening among diverse baby boomers in the area.

Locations

Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hepatitis C Virus (HCV) knowledge Participants will be interviewed regarding their HCV knowledge on Day 1 prior to receiving educational materials. They will be interviewed once again approximately one week after receiving educational materials. Day 1 & Day 7
Primary Change in Colorectal Cancer (CRC) knowledge Participants will be interviewed regarding their CRC knowledge on Day 1 prior to receiving educational materials. They will be interviewed once again approximately one week after receiving educational materials. Day 1 & Day 7
Primary Hepatitis C Virus Screening Status Data about participants' HCV screening status will be collected from Federally Qualified Health Care Center's (FQHC) 6 months after participants have received educational materials. at 6 months
Primary Colorectal Cancer Screening Status Data about participants' CRC screening status will be collected from Federally Qualified Health Care Center's (FQHC) 6 months after participants have received educational materials. at 6 months
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