Colorectal CarcinomaSMARTER CRCNCT04890054
Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
A study testing Fecal Immunochemical Test, Interview and Patient Navigation in people with Colorectal Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Fecal Immunochemical Test, Interview and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,696 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 1 Jul 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10)
- CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews)
- CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening
- CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations
- CLINICS: Are served by CCOs agreeing to participate in the project
- CLINICS: Willing to implement the intervention into their clinic for the study
Show all 23Show fewer
- CLINIC STAFF/PROVIDERS: Employed as a clinician or ancillary staff member in a participating clinic
- CLINIC STAFF/PROVIDERS: Willing to participate in data collection activities (e.g., interviews, observation, surveys)
- PATIENTS: Attributed to participating clinic
- PATIENTS: Are enrolled in Medicaid or dual eligible
- PATIENTS: Eligible for colorectal cancer (CRC) screening
- PATIENTS: For the subset of patients that will be invited to participate in key informant interviews, a 5th eligibility criteria is consented to participate
- COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: (Includes endoscopy providers, community-based outreach workers, or leaders from regional or national organizations who participate in the pilot, pragmatic trial, or scale-up study)
- COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Involved in study activities (training, care delivery)
- COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Willing to participate in data collection activities (e.g., trainings, interviews, surveys)
- Elderly - Yes - we anticipate that a limited number of clinic and CCO staff, or community organization representatives may be elderly; we limit our patient recruitment to those aged 45-75
- Rural - Yes
- Inner city - No
- Low income - Yes
- Disabled - Yes
- Chronic care - Yes
- End of life - Yes - This is possible, but we predict limited numbers because of the types of individuals we are recruiting: clinic and CCO staff, and patients who are not currently in hospice care
- Minorities - Yes
Who cannot join
- CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population
- PATIENTS: Are current for screening
- PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice)
- PATIENTS: Are not an established patient or for other reasons documented by the clinics
- All patients that we recruit will be at least 45 years of age or older
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC)
This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.
Read the detailed description
PRIMARY OBJECTIVE:
- Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs.
OUTLINE:
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys.
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months.
Implementation outcomes and adaptations will be evaluated through interviews with clinic staff, patients, and CCO partners. Clinic staff in various roles related to the program (e.g., outreach workers, patient navigators, quality improvement leads) complete surveys and participate in interviews and observations at baseline, 6-9 months (post-implementation) and at approximately 12 months later, to assess clinic/health system level factors that may influence outcomes. Patients participate in interviews to explore patient experiences with the program. Regional and Organizational partners: CCO leaders, endoscopy providers (e.g., gastrointestinal specialists, general surgeons, primary care clinicians), and community organizations also participate in interviews.
- Conditions
- Colorectal Carcinoma
- Being tested
- Fecal Immunochemical Test, Interview, Patient Navigation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Immunochemical TestOther
Also called FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test
Patients due for CRC screening are mailed a FIT test by the clinic or health plan
InterviewOther
Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations
Patient NavigationBehavioural
Also called Patient Navigator Program
Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators
| Study group | Role | What they receive |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Active comparator | In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Receives: Other: Fecal Immunochemical Test; Other: Interview; Behavioral: Patient Navigation |
| SMARTER CRC Usual Care | No intervention | Usual clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients)
Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number [%] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.
Measured: Primary outcome at 6 months following CCO eligible patient list pull date,
Secondary outcomes (10)
Completion of CRC Screening
Completed CRC screening at 12 months. Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy).
Measured: Up to 12 months
Rate of CRC Screening Among the Intervention-eligible Population
In the intervention clinics only, the list of patients eligible for screening was scrubbed by clinics. This percent is the N completed CRC screening out of the N included in intervention outreach after clinics scrubbed the list of eligible patients.
Measured: 6 months
Time to Screening From Study-eligible Patient List Pull
Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level.
Measured: Up to 12 months
Abnormal FIT Results
Number of participants with abnormal FIT Results
Measured: 6 months
Patient Navigation Trainings (Intervention Group)
Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial
Measured: Up to 12 months
Patient Navigation Completed (Intervention Group)
Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).
Measured: Up to 12 months
Follow-up Colonoscopy Completion
The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months
Measured: Up to 12 months
Time to Colonoscopy From Abnormal FIT Result
Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.
Measured: Up to 12 months
Adenomas or Cancers Detected
Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.
Measured: Up to 12 months
Key Implementation Barriers
Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start14 May 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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 (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,696 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Davis, OHSU Knight Cancer Institute
- Investigators
- Melinda Davis, PhD, Principal investigator, OHSU Knight Cancer InstituteGloria Coronado, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890054
- Sponsor's protocol ID
- STUDY00020681
- Other IDs
- NCI-2021-01032, STUDY00020681, UH3CA244298
- Acronym
- SMARTER CRC
- Status last verified
- Jul 2025
- First submitted
- 12 May 2021
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All non-identifiable data is going to be available through the ACCSIS coordinating center as a public common data set across all the ACCSIS studies along with paper-specific de-identified data sets.
Publications
Kenzie ES, Herreid-O'Neill A, Myers E, Coury J, Badicke B, Coronado G, Davis MM. Facilitation of Health Plan-Clinic Partnerships to Improve Colorectal Cancer Screening for Rural Medicaid Enrollees: A Qualitative Study. J Rural Health. 2026 Jun;42(3):e70203. doi: 10.1111/jrh.70203.
PubMed 42572815Currier JJ, Coury J, Myers E, Kenzie ES, Petrik AF, Badicke B, McDonnell MM, Abbott MC, Coronado GD, Davis MM. Scale-up evaluation results of a multi-level approach using mailed immunochemical test (FIT) and patient navigation to increase colorectal cancer screening rates in rural clinic settings. BMC Prim Care. 2026 Jul 14. doi: 10.1186/s12875-026-03428-w. Online ahead of print.
PubMed 42449237Coronado GD, Petrik AF, Leo MC, Coury J, Durr R, Badicke B, Thompson JH, Edelmann AC, Davis MM. Mailed Outreach and Patient Navigation for Colorectal Cancer Screening Among Rural Medicaid Enrollees: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250928. doi: 10.1001/jamanetworkopen.2025.0928.
PubMed 40094661Coury J, Coronado G, Currier JJ, Kenzie ES, Petrik AF, Badicke B, Myers E, Davis MM. Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas. Implement Sci Commun. 2024 Jan 8;5(1):6. doi: 10.1186/s43058-023-00540-1.
PubMed 38191536Coronado GD, Leo MC, Ramsey K, Coury J, Petrik AF, Patzel M, Kenzie ES, Thompson JH, Brodt E, Mummadi R, Elder N, Davis MM. Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial. Implement Sci Commun. 2022 Apr 13;3(1):42. doi: 10.1186/s43058-022-00285-3.
PubMed 35418107
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC)
- ClinicalTrials.gov ID
- NCT04890054
- Acronym / sponsor ID
- SMARTER CRC / STUDY00020681
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,696 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 14 May 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.
Detailed description
PRIMARY OBJECTIVE:
- Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs.
OUTLINE:
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys.
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months.
Implementation outcomes and adaptations will be evaluated through interviews with clinic staff, patients, and CCO partners. Clinic staff in various roles related to the program (e.g., outreach workers, patient navigators, quality improvement leads) complete surveys and participate in interviews and observations at baseline, 6-9 months (post-implementation) and at approximately 12 months later, to assess clinic/health system level factors that may influence outcomes. Patients participate in interviews to explore patient experiences with the program. Regional and Organizational partners: CCO leaders, endoscopy providers (e.g., gastrointestinal specialists, general surgeons, primary care clinicians), and community organizations also participate in interviews.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Active comparator | Other: Fecal Immunochemical Test, Other: Interview, Behavioral: Patient NavigationIn year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. |
| SMARTER CRC Usual Care | No intervention | –Usual clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10)
- CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews)
- CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening
- CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations
- CLINICS: Are served by CCOs agreeing to participate in the project
Key exclusion criteria (5 listed)
- CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population
- PATIENTS: Are current for screening
- PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice)
- PATIENTS: Are not an established patient or for other reasons documented by the clinics
- All patients that we recruit will be at least 45 years of age or older
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 |
|---|---|---|
| Fecal Immunochemical TestAlso: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood testPatients due for CRC screening are mailed a FIT test by the clinic or health plan | Other | SMARTER CRC Intervention Year 1 |
| InterviewParticipate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations | Other | SMARTER CRC Intervention Year 1 |
| Patient NavigationAlso: Patient Navigator ProgramClinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators | Behavioural | SMARTER CRC Intervention Year 1 |
Primary outcome
Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients)
Time frame: Primary outcome at 6 months following CCO eligible patient list pull date,
Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number [%] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.
10 secondary outcomes
Completion of CRC Screening
Time frame: Up to 12 months
Rate of CRC Screening Among the Intervention-eligible Population
Time frame: 6 months
Time to Screening From Study-eligible Patient List Pull
Time frame: Up to 12 months
Abnormal FIT Results
Time frame: 6 months
Patient Navigation Trainings (Intervention Group)
Time frame: Up to 12 months
Patient Navigation Completed (Intervention Group)
Time frame: Up to 12 months
Follow-up Colonoscopy Completion
Time frame: Up to 12 months
Time to Colonoscopy From Abnormal FIT Result
Time frame: Up to 12 months
Adenomas or Cancers Detected
Time frame: Up to 12 months
Key Implementation Barriers
Time frame: Up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42572815Kenzie ES, Herreid-O'Neill A, Myers E, Coury J, Badicke B, Coronado G, Davis MM. Facilitation of Health Plan-Clinic Partnerships to Improve Colorectal Cancer Screening for Rural Medicaid Enrollees: A Qualitative Study. J Rural Health. 2026 Jun;42(3):e70203. doi: 10.1111/jrh.70203.
- Derived from this study: PubMed 42449237Currier JJ, Coury J, Myers E, Kenzie ES, Petrik AF, Badicke B, McDonnell MM, Abbott MC, Coronado GD, Davis MM. Scale-up evaluation results of a multi-level approach using mailed immunochemical test (FIT) and patient navigation to increase colorectal cancer screening rates in rural clinic settings. BMC Prim Care. 2026 Jul 14. doi: 10.1186/s12875-026-03428-w. Online ahead of print.
- Derived from this study: PubMed 40094661Coronado GD, Petrik AF, Leo MC, Coury J, Durr R, Badicke B, Thompson JH, Edelmann AC, Davis MM. Mailed Outreach and Patient Navigation for Colorectal Cancer Screening Among Rural Medicaid Enrollees: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250928. doi: 10.1001/jamanetworkopen.2025.0928.
- Derived from this study: PubMed 38191536Coury J, Coronado G, Currier JJ, Kenzie ES, Petrik AF, Badicke B, Myers E, Davis MM. Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas. Implement Sci Commun. 2024 Jan 8;5(1):6. doi: 10.1186/s43058-023-00540-1.
- Derived from this study: PubMed 35418107Coronado GD, Leo MC, Ramsey K, Coury J, Petrik AF, Patzel M, Kenzie ES, Thompson JH, Brodt E, Mummadi R, Elder N, Davis MM. Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial. Implement Sci Commun. 2022 Apr 13;3(1):42. doi: 10.1186/s43058-022-00285-3.
- Individual participant dataSharing planned: Yes. All non-identifiable data is going to be available through the ACCSIS coordinating center as a public common data set across all the ACCSIS studies along with paper-specific de-identified data sets.
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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.
Melinda Davis, PhD principal investigator
OHSU Knight Cancer Institute
Gloria Coronado, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Immunochemical Test, Interview and Patient Navigation in people with Colorectal Carcinoma, run by OHSU Knight Cancer 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 23 inclusion and 5 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 19 Aug 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?
Yes. Results are posted in the registry (first posted 19 Aug 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?
Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) (time frame: Primary outcome at 6 months following CCO eligible patient list pull date,). 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 NCT04890054, which also lists 5 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 19 Aug 2025.