Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health (CARES-REACH)
December 2, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute
This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Staff and providers from the two participating Federally Qualified Health Care systems - Central Florida Health Centers and Manatee County Rural Health Services.
Description
Inclusion Criteria:
- Staff and providers working in a clinic within one of the two participating systems
- Involved in adult patient care
Exclusion Criteria:
- Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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)
|
|
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.
|
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.
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Colorectal Cancer Screening Rates - Initial FIT
Time Frame: Years 1-5
|
Percentage of patients who complete initial Fecal Immunochemical Test (FIT)
|
Years 1-5
|
|
Change in Colorectal Cancer Screening Rates - Repeat FIT
Time Frame: Years 1-5
|
Percentage of patients who complete a repeat Fecal Immunochemical Test (FIT)
|
Years 1-5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in Screening Rates
Time Frame: Years 2-5
|
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.
|
Years 2-5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Clement K Gwede, PhD MPH RN FAAN, Moffitt Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2020
Primary Completion (Estimated)
October 26, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Estimated)
December 3, 2025
Last Update Submitted That Met QC Criteria
December 2, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-20560
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.