Colorectal CancerCARES-REACHNCT04464668
Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health
An observational study of Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Provider Tools and Provider surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Staff and providers from the two participating Federally Qualified Health Care systems - Central Florida Health Centers and Manatee County Rural Health Services.
Who may be able to join
- Staff and providers working in a clinic within one of the two participating systems
- Involved in adult patient care
Who cannot join
- Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening
Trial locations and contacts
1 site in 1 country.
About this study
This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.
Read the detailed description
This study will not accrue individual patients. Instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.
- Conditions
- Colorectal Cancer
- Being tested
- Provider Tools, Provider surveys
- Keywords
- Fecal Immunochemical Test, F.I.T.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider ToolsBehavioural
Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.
Provider surveysBehavioural
Remote/electronic data collection surveys will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 Only: Clinics using CARES Intervention | Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics to implement the Colorectal Cancer Awareness, Research, Education \& Screening (CARES) intervention. Receives: Behavioral: Provider Tools; Behavioral: Provider surveys | |
| Wave 1 Only: Control Clinics | Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics as control (usual care) clinics. | |
| All Clinics | For Wave 2, the 7 clinics in the control group will roll out as intervention clinic, thus, all 14 clinics will be exposed to the intervention by year 2. Receives: Behavioral: Provider Tools; Behavioral: Provider surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Colorectal Cancer Screening Rates - Initial FIT
Percentage of patients who complete initial Fecal Immunochemical Test (FIT)
Measured: Years 1-5
Change in Colorectal Cancer Screening Rates - Repeat FIT
Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)
Measured: Years 1-5
Secondary outcomes (1)
Differences in Screening Rates
Screening rate differences to determine how variables such as clinic setting (rural vs urban), population characteristics such as nativity (foreign born status), language preference, education, income, health insurance, etc. differentially impact annual clinic Colorectal Cancer (CRC) screening rates.
Measured: Years 2-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start25 Jun 2020
- Primary completion26 Oct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clement K Gwede, PhD MPH RN FAAN, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464668
- Sponsor's protocol ID
- MCC-20560
- Acronym
- CARES-REACH
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2020
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Pollard J, Friedman M, Byrne MM, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center Clinics: A stepped-wedge, multilevel intervention trial. Contemp Clin Trials. 2026 May;164:108274. doi: 10.1016/j.cct.2026.108274. Epub 2026 Mar 2.
PubMed 41780746Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Joshua A, Pollard J, Friedman M, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center clinics: A stepped-wedge, multilevel intervention trial. Res Sq [Preprint]. 2024 Jul 18:rs.3.rs-4558718. doi: 10.21203/rs.3.rs-4558718/v1.
PubMed 39070625
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health
- ClinicalTrials.gov ID
- NCT04464668
- Acronym / sponsor ID
- CARES-REACH / MCC-20560
- Conditions
- Colorectal Cancer
- Keywords
- Fecal Immunochemical Test, F.I.T.
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jul 2020 (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.
This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.
Detailed description
This study will not accrue individual patients. Instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wave 1 Only: Clinics using CARES Intervention | – | Behavioral: Provider Tools, Behavioral: Provider surveysBased on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics to implement the Colorectal Cancer Awareness, Research, Education \& Screening (CARES) intervention. |
| Wave 1 Only: Control Clinics | – | –Based on a stratified (rural vs urban) procedure, investigators will randomly select 7 clinics as control (usual care) clinics. |
| All Clinics | – | Behavioral: Provider Tools, Behavioral: Provider surveysFor Wave 2, the 7 clinics in the control group will roll out as intervention clinic, thus, all 14 clinics will be exposed to the intervention by year 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Staff and providers from the two participating Federally Qualified Health Care systems - Central Florida Health Centers and Manatee County Rural Health Services.
Key inclusion criteria (2 listed)
- Staff and providers working in a clinic within one of the two participating systems
- Involved in adult patient care
Key exclusion criteria (1 listed)
- Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening
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 |
|---|---|---|
| Provider ToolsProviders will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients. | Behavioural | All Clinics, Wave 1 Only: Clinics using CARES Intervention |
| Provider surveysRemote/electronic data collection surveys will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation) | Behavioural | All Clinics, Wave 1 Only: Clinics using CARES Intervention |
Primary outcome
Change in Colorectal Cancer Screening Rates - Initial FIT
Time frame: Years 1-5
Percentage of patients who complete initial Fecal Immunochemical Test (FIT)
Change in Colorectal Cancer Screening Rates - Repeat FIT
Time frame: Years 1-5
Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)
1 secondary outcome
Differences in Screening Rates
Time frame: Years 2-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 41780746Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Pollard J, Friedman M, Byrne MM, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center Clinics: A stepped-wedge, multilevel intervention trial. Contemp Clin Trials. 2026 May;164:108274. doi: 10.1016/j.cct.2026.108274. Epub 2026 Mar 2.
- Derived from this study: PubMed 39070625Montoya SM, Olaore P, Bastardo-Acosta J, Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Joshua A, Pollard J, Friedman M, Christy SM, Meade CD, Gwede CK. Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center clinics: A stepped-wedge, multilevel intervention trial. Res Sq [Preprint]. 2024 Jul 18:rs.3.rs-4558718. doi: 10.21203/rs.3.rs-4558718/v1.
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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 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 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 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 Colorectal Cancer Screening Rates - Initial FIT (time frame: Years 1-5). 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?
On the ClinicalTrials.gov record for NCT04464668, which also lists 2 linked publications.
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 3 Dec 2025.