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Colorectal Cancer ScreeningSCREENNCT06401174

Patient Navigation for Colorectal Cancer Screening

A study testing Delivery of patient navigation in people with Colorectal Cancer Screening, run by Medstar Health Research Institute at 15 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities, but there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Colorectal Cancer Screening
What is being tested?
Delivery of patient navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
15 sitesUnited States
Study dates
1 Jun 2024to 30 Jul 2028
Phase
Interventional
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 45-75
  • Due for colorectal cancer screening
  • Identify as Black or Hispanic/Latino
  • Attend primary care visit at one of the 15 selected clinics within the step time -period

Who cannot join

  • -

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

15 sites in 1 country

United States15 sites

  • Honeygo

    Baltimore, Maryland, 21128

  • MedStar Adult Medicine at Union Memorial

    Baltimore, Maryland, 21218

  • Harbor Hospital Primary Care Federal Hill

    Baltimore, Maryland, 21230

  • Franklin Square

    Baltimore, Maryland, 21237

  • Primary Care at Franklin Square

    Baltimore, Maryland, 21237

  • Charlotte Hall

    Charlotte Hall, Maryland, 20622

  • Internal Medicine Clinton

    Clinton, Maryland, 20735

  • Family Medicine

    Gaithersburg, Maryland, 20878

  • Internal Medicine Hyattsville

    Hyattsville, Maryland, 20782

  • Family Medicine

    Olney, Maryland, 20832

  • Olney Prof Park

    Olney, Maryland, 20832

  • Internal Medicine Wisconsin Avenue

    Washington D.C., District of Columbia, 20007

  • Family Medicine Spring Valley

    Washington D.C., District of Columbia, 20016

  • Primary Care Lafayette

    Washington D.C., District of Columbia, 20036

  • Family Medicine Fort Lincoln

    Washington D.C., District of Columbia, 20722

Other trials in United States

About this study

Official title: Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities, but there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices. The investigators will conduct a stepped-wedge, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. The research team will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or colorectal cancer screening completion.

Read the detailed description

Colorectal cancer (CRC) screening is recommended by the United States Preventative Services Task Force for adults age 45-75. Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities. While patient navigation is an evidence-based approach to improve screening, there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices, particularly using a health-equity focused, stakeholder-centered approach. Guided by the Practical, Robust Implementation and Sustainability Model (PRISM) and core health and racial equity principles, the investigative team aims to increase reach of patient navigation and show effectiveness through improvement in the percentage of Black and Hispanic patients completing CRC screening. Investigators will also utilize longitudinal tracking of implementation strategies to better track implementation or intervention adaptations navigation delivery in order to inform future scale up. The research team will conduct a stepped-wedged, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. Researchers will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or CRC screening completion.

Being tested
Delivery of patient navigation
Keywords
disparities, Patient navigation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delivery of patient navigationBehavioural

    Clinics will receive educational materials and access a referral order for patient navigation. Iterative strategies will be used to increase CRC screening

Study groups in NCT06401174
Study groupRoleWhat they receive
Patient navigationExperimentalPatient navigation will be rolled out at the clinic level (15 clinics). Referral orders will become available to participating clinics, with education and audit and feedback for providers. The study team will tailor patient navigation supports by clinic site for specifics on how the intervention is delivered.
Receives: Behavioral: Delivery of patient navigation
Usual careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colorectal cancer screening completion

    Completion of any USPSTF approved screening test

    Measured: 12 months

Secondary outcomes (6)

  1. Reach

    Percent of patients referred out of those eligible

    Measured: 6 months

  2. Adoption

    Percent of providers referring to patient navigation

    Measured: 6 months

  3. Acceptability measured by the Acceptability of Intervention Measure (AIM)

    Stakeholder assessments of acceptability of navigation and implementation strategies measured on a four-item scale

    Measured: 12 months

  4. Appropriateness measured by the Intervention Appropriateness Measure (IAM)

    Stakeholder assessments of appropriateness of navigation and implementation strategies measured on a four-item scale

    Measured: 12 months

  5. Feasibility measured by the Feasibility of Implementation Measure (FIM)

    Stakeholder assessments of feasibility of navigation and implementation strategies measured on 4 item scale

    Measured: 12 months

  6. Sustainability measured by the clinical sustainability assessment tool

    Understanding clinical sustainability of interventions

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start1 Jun 2024
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion30 Jul 2028 (estimated)

Resources

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
Sequential
Model description
Step wedge trial with 5 six-month steps, three clinics at a time, for a total of 15 clinics.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401174
Sponsor's protocol ID
6963
Acronym
SCREEN
Status last verified
Oct 2025
First submitted
22 Apr 2024
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rivera Rivera JN, AuBuchon KE, Schubel LC, Starling C, Tran J, Locke M, Grady M, Mete M, Blumenthal HJ, Galarraga JE, Arem H. Supporting ColoREctal Equitable Navigation (SCREEN): a protocol for a stepped-wedge cluster randomized trial for patient navigation in primary care. Implement Sci Commun. 2024 Jun 3;5(1):60. doi: 10.1186/s43058-024-00598-5.

    PubMed 38831365

Questions about this trial

What is this clinical trial studying?

A study testing Delivery of patient navigation in people with Colorectal Cancer Screening, run by Medstar Health Research Institute at 15 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 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: enrolling by invitation, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

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?

Colorectal cancer screening completion (time frame: 12 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 NCT06401174, 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 22 Oct 2025.

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