Hepatitis C Virus InfectionNCT04980157
CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers
An observational study of Hepatitis C Virus Infection and Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 56 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus Infection, Colorectal Cancer
- What is being tested?
- CARES-HCV
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients born between 1945-1965 up to age 75 who have clinic visits at a partnering federally qualified health center.
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatitis C Virus Infection, Colorectal Cancer
- Being tested
- CARES-HCV
- Keywords
- HCV Screening, CRC Screening
- Medical subject headings
- Hepatitis C, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARES-HCVBehavioural
CARES-HCV is an educational intervention to promote both hepatitis c screening and colorectal cancer screening among diverse baby boomers in the area.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Patients born between 1945-1965 who have clinic visits at a partnering federally qualified health center. Receives: Behavioral: CARES-HCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Nov 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon M Christy, PhD, Principal investigator, Moffitt Cancer CenterClement K Gwede, PhD, MPH, RN, FAAN, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980157
- Sponsor's protocol ID
- MCC-20601
- Status last verified
- Jan 2023
- First submitted
- 19 Jul 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARES-HCV: Promoting Concurrent Hepatitis C Virus Screening and Colorectal Cancer Screening Uptake Among Diverse Baby Boomers
- ClinicalTrials.gov ID
- NCT04980157
- Acronym / sponsor ID
- MCC-20601
- Conditions
- Hepatitis C Virus Infection, Colorectal Cancer
- Keywords
- HCV Screening, CRC Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Behavioral: CARES-HCVPatients born between 1945-1965 who have clinic visits at a partnering federally qualified health center. |
Who may qualify
- Ages
- 56 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients born between 1945-1965 up to age 75 who have clinic visits at a partnering federally qualified health center.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARES-HCVCARES-HCV is an educational intervention to promote both hepatitis c screening and colorectal cancer screening among diverse baby boomers in the area. | Behavioural | All Participants |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M Christy, PhD principal investigator
Moffitt Cancer Center
Clement K Gwede, PhD, MPH, RN, FAAN principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection and Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepatitis C Virus (HCV) knowledge (time frame: Day 1 & Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.