NCT04980157

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

July 19, 2021

Last Update Submit

January 20, 2023

Conditions

Hepatitis C Virus InfectionColorectal Cancer

Keywords

HCV ScreeningCRC Screening

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

All Participants

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

Behavioral: CARES-HCV

Interventions

CARES-HCVBEHAVIORAL

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

All Participants

Eligibility Criteria

Age56 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Hepatitis CColorectal Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Shannon M Christy, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

  • Clement K Gwede, PhD, MPH, RN, FAAN

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 28, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

US(1)