Cancer of ColonNCT04812743
Colorectal Health Research Champions
A study testing Colorectal Health Research Champions in people with Cancer of Colon and Cancer of Rectum, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of the Colorectal Health Research Champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research. Read more about this study
- Who is it for?
- Ages 30 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer of Colon, Cancer of Rectum
- What is being tested?
- Colorectal Health Research Champions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 15 May 2023
- Phase
- Interventional
- 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 30 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the individual is > 30 years of age
- They are literate
- They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research.
- To participate in a chat hosted by the CHRC the inclusion criteria is:
- adult of any gender
- over 30 years of age.
Who cannot join
- -Those < 30 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of the Colorectal Health Research Champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research.
- Conditions
- Cancer of Colon, Cancer of Rectum
- Being tested
- Colorectal Health Research Champions
- Keywords
- Prevention
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal Health Research ChampionsBehavioural
20 Colorectal Health Research Champions will be recruited from the VCU Massey Cancer Center Catchment Area (66 counties in Virginia) The Colorectal Health Research Champions will receive training in four specific areas during group educational sessions.
Colorectal Health Research Champions will be asked to disseminate the four defined messages on at least two occasions to small groups in their social network in a venue of their choice (house chats, faith-based, social gatherings, family gatherings, etc.). We ask that each CHRC participant host 2 chats with 5-10 people in attendance at each chat. We expect that at least 200 participants will be invited to chats through 10 CHRCs.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Health Research Champion trainees | Experimental | Colorectal Health Research Champion (CHRC) trainees receive 5 education sessions on colorectal cancer, clinical research, biospecimen donation, ethics, and presentation skills. The CHRCs will invite others in their social networks to present to them this educational information, following the train the trainer model of health education. Receives: Behavioral: Colorectal Health Research Champions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in participants knowledge and intentions related to colorectal cancer screening.
Participant knowledge will be measured using pre/post questionnaires, with each correct answer being worth one point (14 total points) Higher summary scores indicate a greater change in knowledge. Intentions are measured on a 5 -point likert scale.
Measured: 4 months
Increase in knowledge and intentions related to biospecimen donation and clinical trial participation.
Participant knowledge and intentions related to biospecimen donation and clinical trial participation will be measured using pre/post questionnaires, with each correct answer being worth one point (20 total points). Higher summary scores indicate a greater change in knowledge. Intentions are measured on a 5 -point likert scale.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start10 Jan 2020
- Primary completion15 May 2023
- Study completion15 May 2023
Why it stopped: End of grant funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa B Sheppard, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812743
- Sponsor's protocol ID
- MCC-19-15899
- Other IDs
- HM20017398, NCI-2019-08595
- Status last verified
- Feb 2024
- First submitted
- 16 Dec 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Health Research Champions
- ClinicalTrials.gov ID
- NCT04812743
- Acronym / sponsor ID
- MCC-19-15899
- Conditions
- Cancer of Colon, Cancer of Rectum
- Keywords
- Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of grant funding
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 24 Mar 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 Colorectal Health Research Champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Health Research Champion trainees | Experimental | Behavioral: Colorectal Health Research ChampionsColorectal Health Research Champion (CHRC) trainees receive 5 education sessions on colorectal cancer, clinical research, biospecimen donation, ethics, and presentation skills. The CHRCs will invite others in their social networks to present to them this educational information, following the train the trainer model of health education. |
Who may qualify
- Ages
- 30 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the individual is > 30 years of age
- They are literate
- They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research.
- adult of any gender
- over 30 years of age.
Key exclusion criteria (1 listed)
- -Those < 30 years of age
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 |
|---|---|---|
| Colorectal Health Research Champions20 Colorectal Health Research Champions will be recruited from the VCU Massey Cancer Center Catchment Area (66 counties in Virginia) The Colorectal Health Research Champions will receive training in four specific areas during group educational sessions. Colorectal Health Research Champions will be asked to disseminate the four defined messages on at least two occasions to small groups in their social network in a venue of their choice (house chats, faith-based, social gatherings, family gatherings, etc.). We ask that each CHRC participant host 2 chats with 5-10 people in attendance at each chat. We expect that at least 200 participants will be invited to chats through 10 CHRCs. | Behavioural | Colorectal Health Research Champion trainees |
Primary outcome
Increase in participants knowledge and intentions related to colorectal cancer screening.
Time frame: 4 months
Participant knowledge will be measured using pre/post questionnaires, with each correct answer being worth one point (14 total points) Higher summary scores indicate a greater change in knowledge. Intentions are measured on a 5 -point likert scale.
Increase in knowledge and intentions related to biospecimen donation and clinical trial participation.
Time frame: 4 months
Participant knowledge and intentions related to biospecimen donation and clinical trial participation will be measured using pre/post questionnaires, with each correct answer being worth one point (20 total points). Higher summary scores indicate a greater change in knowledge. Intentions are measured on a 5 -point likert scale.
Results and safety
The study was stopped early (reason given: End of grant funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Vanessa B Sheppard, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal Health Research Champions in people with Cancer of Colon and Cancer of Rectum, run by Virginia Commonwealth University 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Feb 2024. 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 was stopped early (reason given: End of grant funding). Results are not available in the source record.
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?
Increase in participants knowledge and intentions related to colorectal cancer screening. (time frame: 4 months). The study lists 2 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 13 Feb 2024.