Colorectal CancerCARESNCT05714644
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
A study testing FIT kit Screening Test and Cologuard Screening Test in people with Colorectal Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FIT kit Screening Test and Cologuard Screening Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,127 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jun 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-75
- Has had a visit at a participating community clinic within the last two years.
- Alive
- Patient's preferred language is English or Spanish
Who cannot join
- Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below).
- Has colorectal cancer documented in the problem list. (Codes below).
- Has had a FIT in the past 1 year
- Has had a colonoscopy in the past 10 years
- ICD-10 codes for exclusion criteria:
- Ulcerative colitis:
Show all 40Show fewer
- K51.0
- K51.2
- K51.3
- K51.4
- K51.5
- K51.8
- K51.9
- K52.8
- K52.9
- Crohn's disease:
- K50.0
- K50.1
- K50.8
- K50.9
- Colorectal cancer
- C18 (malignant neoplasm of colon)
- C18.0 (malignant neoplasm of cecum)
- C18.1 (malignant neoplasm of appendix)
- C18.2 (malignant neoplasm of ascending colon)
- C18.3 (malignant neoplasm of hepatic flexure)
- C18.4 (malignant neoplasm of transverse colon)
- C18.5 (malignant neoplasm of splenic flexure)
- C18.6 (malignant neoplasm of descending colon)
- C18.7 (malignant neoplasm of sigmoid colon)
- C18.8 (malignant neoplasm of overlapping sites of colon)
- C18.9 (malignant neoplasm of colon, unspecified)
- C19 (malignant neoplasm of rectosigmoid junction)
- C20 (malignant neoplasm of rectum)
- C21.8 (malignant neoplasm of overlapping sites of rectum, anus and anal canal)
- C26.0 (malignant neoplasm of intestinal tract, part unspecified)
- C78.5 (secondary malignant neoplasm of large intestine and rectum)
- C78.6 (secondary malignant neoplasm of retroperitoneum and peritoneum)
- D37.4 (neoplasm of uncertain behavior of colon)
- D37.5 (neoplasm of uncertain behavior of rectum)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mass General Brigham
Boston, Massachusetts, 02114
UCLA
Los Angeles, California, 90095-1772
Great Plains Tribal Leaders Health Board
Rapid City, South Dakota, 57703
About this study
The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.
Read the detailed description
This is a 3-year pragmatic trial with four levels of intervention, including system-, provider-, patient-, and community-level components at each of the CARES clinical sites. Health system components will include the development and implementation of a CRC screening registry and tracking database to systematically and actively track patients overdue for screening, screening test completion, and abnormal screening results. Data systems will be coupled with process re-design to improve clinical workflow for screening outreach. Providers will receive educational support through a training session about the importance of CRC screening, screening test options, population management, and an instructional on how to complete a Cologuard kit (Cologuard arm only) or a FIT kit (FIT arm only). Patient components of the intervention vary by study arm. In sites randomized to Cologuard, patients will receive a mailed Cologuard kit and the Exact Sciences patient support program. Patients in clinics randomized to FIT will receive a mailed FIT kit with systematic reminders. Patients who test positive will be offered patient navigation to assist with completing a diagnostic colonoscopy.
- Conditions
- Colorectal Cancer
- Being tested
- FIT kit Screening Test, Cologuard Screening 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.
FIT kit Screening TestOther
FIT kit mailed to the patient's home
Cologuard Screening TestOther
Cologuard test mailed to the patient's home
| Study group | Role | What they receive |
|---|---|---|
| Mailed FIT Kit | Active comparator | A FIT kit mailed to the patient's home Receives: Other: FIT kit Screening Test |
| Cologuard | Active comparator | A Cologuard test mailed to the patient's home Receives: Other: Cologuard Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC Screening Completion Rates
completion rate of the stool-based screening test (FIT or Cologuard)
Measured: 3 months
Secondary outcomes (2)
CRC Screening Completion Rates
completion rate of the stool-based screening test (Cologuard or FIT)
Measured: 6 months
Diagnostic Colonoscopy Completion Rates
completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start7 Jun 2023
- Primary completion30 Jun 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Massachusetts General HospitalThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Health Centers are randomized to FIT testing or Cologuard.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stand Up To Cancer, University of California, Los Angeles, Great Plains Tribal Leaders Health Board
- Responsible party
- Principal investigator, Jennifer S Haas, MD, Massachusetts General Hospital
- Investigators
- Jennifer Haas, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714644
- Sponsor's protocol ID
- 2022P001678
- Acronym
- CARES
- Status last verified
- Dec 2025
- First submitted
- 27 Jan 2023
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
May FP, Brodney S, Tuan JJ, Syngal S, Chan AT, Glenn B, Johnson G, Chang Y, Drew DA, Moy B, Rodriguez NJ, Warner ET, Anyane-Yeboa A, Ukaegbu C, Davis AQ, Schoolcraft K, Regan S, Yoguez N, Kuney S, Le Beaux K, Jeffries C, Lee ET, Bhat R, Haas JS. Community Collaboration to Advance Racial/Ethnic Equity in Colorectal Cancer Screening: Protocol for a Multilevel Intervention to Improve Screening and Follow-up in Community Health Centers. Contemp Clin Trials. 2024 Oct;145:107639. doi: 10.1016/j.cct.2024.107639. Epub 2024 Jul 26.
PubMed 39068985May FP, Brodney S, Tuan JJ, Syngal S, Chan AT, Glenn B, Johnson G, Chang Y, Drew DA, Moy B, Rodriguez NJ, Warner ET, Anyane-Yeboa A, Ukaegbu C, Davis AQ, Schoolcraft K, Regan S, Le Beaux K, Lee ET, Bhat R, Gordon A, Phan LK, Chirino AFC, Marotta CJ, Kindermann RGZ, Haas JS. Mailed Outreach for Colorectal Cancer Screening in Community Health Centers: The CARES Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):703-712. doi: 10.1001/jamainternmed.2026.1170.
PubMed 42043827
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
- ClinicalTrials.gov ID
- NCT05714644
- Acronym / sponsor ID
- CARES / 2022P001678
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,127 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Stand Up To Cancer, University of California, Los Angeles, Great Plains Tribal Leaders Health Board
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 26 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.
Detailed description
This is a 3-year pragmatic trial with four levels of intervention, including system-, provider-, patient-, and community-level components at each of the CARES clinical sites. Health system components will include the development and implementation of a CRC screening registry and tracking database to systematically and actively track patients overdue for screening, screening test completion, and abnormal screening results. Data systems will be coupled with process re-design to improve clinical workflow for screening outreach. Providers will receive educational support through a training session about the importance of CRC screening, screening test options, population management, and an instructional on how to complete a Cologuard kit (Cologuard arm only) or a FIT kit (FIT arm only). Patient components of the intervention vary by study arm. In sites randomized to Cologuard, patients will receive a mailed Cologuard kit and the Exact Sciences patient support program. Patients in clinics randomized to FIT will receive a mailed FIT kit with systematic reminders. Patients who test positive will be offered patient navigation to assist with completing a diagnostic colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Health Centers are randomized to FIT testing or Cologuard.
| Arm | Type | Receives |
|---|---|---|
| Mailed FIT Kit | Active comparator | Other: FIT kit Screening TestA FIT kit mailed to the patient's home |
| Cologuard | Active comparator | Other: Cologuard Screening TestA Cologuard test mailed to the patient's home |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45-75
- Has had a visit at a participating community clinic within the last two years.
- Alive
- Patient's preferred language is English or Spanish
Key exclusion criteria (40 listed)
- Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below).
- Has colorectal cancer documented in the problem list. (Codes below).
- Has had a FIT in the past 1 year
- Has had a colonoscopy in the past 10 years
- K51.0
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 |
|---|---|---|
| FIT kit Screening TestFIT kit mailed to the patient's home | Other | Mailed FIT Kit |
| Cologuard Screening TestCologuard test mailed to the patient's home | Other | Cologuard |
Primary outcome
CRC Screening Completion Rates
Time frame: 3 months
completion rate of the stool-based screening test (FIT or Cologuard)
2 secondary outcomes
CRC Screening Completion Rates
Time frame: 6 months
Diagnostic Colonoscopy Completion Rates
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39068985May FP, Brodney S, Tuan JJ, Syngal S, Chan AT, Glenn B, Johnson G, Chang Y, Drew DA, Moy B, Rodriguez NJ, Warner ET, Anyane-Yeboa A, Ukaegbu C, Davis AQ, Schoolcraft K, Regan S, Yoguez N, Kuney S, Le Beaux K, Jeffries C, Lee ET, Bhat R, Haas JS. Community Collaboration to Advance Racial/Ethnic Equity in Colorectal Cancer Screening: Protocol for a Multilevel Intervention to Improve Screening and Follow-up in Community Health Centers. Contemp Clin Trials. 2024 Oct;145:107639. doi: 10.1016/j.cct.2024.107639. Epub 2024 Jul 26.
- Derived from this study: PubMed 42043827May FP, Brodney S, Tuan JJ, Syngal S, Chan AT, Glenn B, Johnson G, Chang Y, Drew DA, Moy B, Rodriguez NJ, Warner ET, Anyane-Yeboa A, Ukaegbu C, Davis AQ, Schoolcraft K, Regan S, Le Beaux K, Lee ET, Bhat R, Gordon A, Phan LK, Chirino AFC, Marotta CJ, Kindermann RGZ, Haas JS. Mailed Outreach for Colorectal Cancer Screening in Community Health Centers: The CARES Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):703-712. doi: 10.1001/jamainternmed.2026.1170.
- 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.
Jennifer Haas, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT kit Screening Test and Cologuard Screening Test in people with Colorectal Cancer, run by Massachusetts General Hospital at 3 sites 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 40 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 26 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 3 sites 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?
Yes. Results are posted in the registry (first posted 26 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CRC Screening Completion Rates (time frame: 3 months). 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 NCT05714644, 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 26 Dec 2025.