CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers

January 20, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients born between 1945-1965 up to age 75 who have clinic visits at a partnering federally qualified health center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
Patients born between 1945-1965 who have clinic visits at a partnering federally qualified health center.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hepatitis C Virus (HCV) knowledge
Time Frame: Day 1 & Day 7
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
Change in Colorectal Cancer (CRC) knowledge
Time Frame: Day 1 & Day 7
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
Hepatitis C Virus Screening Status
Time Frame: at 6 months
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
Colorectal Cancer Screening Status
Time Frame: at 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Shannon M Christy, PhD, Moffitt Cancer Center
  • Principal Investigator: Clement K Gwede, PhD, MPH, RN, FAAN, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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