CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers

Colorectal Cancer Clinical Trial

Official title:

CARES-HCV: Promoting Concurrent Hepatitis C Virus Screening and Colorectal Cancer Screening Uptake Among Diverse Baby Boomers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980157
• Other study ID #: MCC-20601
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection

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

External Links

•   Moffitt Cancer Center Clinical Trials website