Colorectal CancerNCT03906110
Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)
An observational study of Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials, Contact Message and Personalized One on One Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 26 May 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Established patients of community health clinics aged 50-75 with average risk of colorectal cancer.
Who may be able to join
- Able to understand, read and speak English or Spanish
- Are not up-to-date with colorectal cancer screening
- No symptoms of colorectal cancer
- Not at increased risk for colorectal cancer due to family history or personal high-risk GI syndromes
Who cannot join
- Symptoms of colorectal cancer
- Family history of colorectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) : A Multilevel Intervention to Increase Colorectal Cancer Screening Adherence In Community Clinics
The purpose of this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening.
- Conditions
- Colorectal Cancer
- Being tested
- Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials, Contact Message, Personalized One on One Education, Fecal Immunochemical Test (FIT)
- Keywords
- Colorectal Cancer Screening, FIT test, Fecal Immunochemical Test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) MaterialsBehavioural
Educational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit.
Contact MessageBehavioural
Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.
Personalized One on One EducationBehavioural
- Trained study coordinators will meet with participant for a brief 15 minute educational session delivered in clinic that summarizes information from the materials and demonstrates FIT collection.
- Email or text reminders with brief messages in clear language will be sent that aim to remind and prompt patients to complete FIT.
- For participants that are not responsive to above, trained study staff will address specific FIT specific hinderances by telephone or in clinic.
- Participants will receive a one page summary of key points of salience of repeat screening "GET FIT AGAIN". Another FIT kit is provided.
Fecal Immunochemical Test (FIT)Diagnostic test
The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.
| Study group | Role | What they receive |
|---|---|---|
| C-Cares | Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits. Receives: Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials; Behavioral: Contact Message; Diagnostic Test: Fecal Immunochemical Test (FIT) | |
| C-Cares Plus | Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) materials, FIT kits, and personalized one-on-one education and coaching. Receives: Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials; Behavioral: Contact Message; Behavioral: Personalized One on One Education; Diagnostic Test: Fecal Immunochemical Test (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Immunochemical Test (FIT) use -Time Point 1
Participants use of FIT kits will be measured based on FIT sample return rate.
Measured: Time Point 1 (at 3 months)
Fecal Immunochemical Test (FIT) Use- Time Point 2
Participants use of FIT kits will be measured based on FIT sample return rate.
Measured: Time Point 2 (up to 18 months)
Fecal Immunochemical Test (FIT) Use- Time Point 3
Participants long term FIT adherence will be measured based on FIT sample return rate.
Measured: Time Point 3 (End of study, up to 30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start3 Apr 2018
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Clement K Gwede, PhD, MPH, RN, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906110
- Sponsor's protocol ID
- MCC-19106
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2019
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christy SM, Sutton SK, Abdulla R, Boxtha C, Gonzalez P, Cousin L, Ewing A, Montoya S, Lopez D, Beehler T, Sanchez J, Carvajal R, Meade CD, Gwede CK. A multilevel, low literacy dual language intervention to promote colorectal cancer screening in community clinics in Florida: A randomized controlled trial. Prev Med. 2022 May;158:107021. doi: 10.1016/j.ypmed.2022.107021. Epub 2022 Mar 17.
PubMed 35305995
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) : A Multilevel Intervention to Increase Colorectal Cancer Screening Adherence In Community Clinics
- ClinicalTrials.gov ID
- NCT03906110
- Acronym / sponsor ID
- MCC-19106
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening, FIT test, Fecal Immunochemical Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 8 Apr 2019 (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 this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Cares | – | Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials, Behavioral: Contact Message, Diagnostic Test: Fecal Immunochemical Test (FIT)Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits. |
| C-Cares Plus | – | Behavioral: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials, Behavioral: Contact Message, Behavioral: Personalized One on One Education, Diagnostic Test: Fecal Immunochemical Test (FIT)Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) materials, FIT kits, and personalized one-on-one education and coaching. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Established patients of community health clinics aged 50-75 with average risk of colorectal cancer.
Key inclusion criteria (4 listed)
- Able to understand, read and speak English or Spanish
- Are not up-to-date with colorectal cancer screening
- No symptoms of colorectal cancer
- Not at increased risk for colorectal cancer due to family history or personal high-risk GI syndromes
Key exclusion criteria (2 listed)
- Symptoms of colorectal cancer
- Family history of colorectal cancer
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 |
|---|---|---|
| Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) MaterialsEducational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit. | Behavioural | C-Cares, C-Cares Plus |
| Contact MessageCard with a general message about colorectal cancer screening. This same message will be delivered at 3 time points. | Behavioural | C-Cares, C-Cares Plus |
| Personalized One on One Education* Trained study coordinators will meet with participant for a brief 15 minute educational session delivered in clinic that summarizes information from the materials and demonstrates FIT collection. * Email or text reminders with brief messages in clear language will be sent that aim to remind and prompt patients to complete FIT. * For participants that are not responsive to above, trained study staff will address specific FIT specific hinderances by telephone or in clinic. * Participants will receive a one page summary of key points of salience of repeat screening "GET FIT AGAIN". Another FIT kit is provided. | Behavioural | C-Cares Plus |
| Fecal Immunochemical Test (FIT)The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample. | Diagnostic test | C-Cares, C-Cares Plus |
Primary outcome
Fecal Immunochemical Test (FIT) use -Time Point 1
Time frame: Time Point 1 (at 3 months)
Participants use of FIT kits will be measured based on FIT sample return rate.
Fecal Immunochemical Test (FIT) Use- Time Point 2
Time frame: Time Point 2 (up to 18 months)
Participants use of FIT kits will be measured based on FIT sample return rate.
Fecal Immunochemical Test (FIT) Use- Time Point 3
Time frame: Time Point 3 (End of study, up to 30 months)
Participants long term FIT adherence will be measured based on FIT sample return rate.
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 20 Apr 2023.
- Background: PubMed 35305995Christy SM, Sutton SK, Abdulla R, Boxtha C, Gonzalez P, Cousin L, Ewing A, Montoya S, Lopez D, Beehler T, Sanchez J, Carvajal R, Meade CD, Gwede CK. A multilevel, low literacy dual language intervention to promote colorectal cancer screening in community clinics in Florida: A randomized controlled trial. Prev Med. 2022 May;158:107021. doi: 10.1016/j.ypmed.2022.107021. Epub 2022 Mar 17.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
- 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.
Clement K Gwede, PhD, MPH, RN principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 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 4 inclusion and 2 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 20 Apr 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?
Fecal Immunochemical Test (FIT) use -Time Point 1 (time frame: Time Point 1 (at 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906110, which also lists 1 linked publication.
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 20 Apr 2023.