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NCT04890054: SMARTER CRC

Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC

Completed NA Results posted Last updated 19 August 2025
What this trial tests

NA trial testing Fecal Immunochemical Test in Colorectal Carcinoma in 5,696 participants. Completed in 1 July 2024.

Timeline
14 May 2021
Primary endpoint
1 July 2024
1 July 2024

Quick facts

Lead sponsorOHSU Knight Cancer Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposescreening
Enrollment5,696
Start date14 May 2021
Primary completion1 July 2024
Estimated completion1 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

OHSU Knight Cancer Institute

Who can join

18 and older, any sex, with Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) Primary · 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 accou

GroupValue95% CI
SMARTER CRC Intervention Year 111.810 – 13.5
SMARTER CRC Usual Care4.53.6 – 5.4
Completion of CRC Screening Secondary · Up to 12 months

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).

GroupValue95% CI
SMARTER CRC Intervention Year 116.815.3 – 18.2
SMARTER CRC Usual Care98.0 – 10.0
Rate of CRC Screening Among the Intervention-eligible Population Secondary · 6 months

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.

GroupValue95% CI
SMARTER CRC Intervention Year 1181
Time to Screening From Study-eligible Patient List Pull Secondary · Up to 12 months

Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level.

GroupValue95% CI
SMARTER CRC Intervention Year 1118.5± 293.9
SMARTER CRC Usual Care103.2± 383.2
Abnormal FIT Results Secondary · 6 months

Number of participants with abnormal FIT Results

GroupValue95% CI
SMARTER CRC Intervention Year 119
Usual Care7
Patient Navigation Trainings (Intervention Group) Secondary · Up to 12 months

Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial

GroupValue95% CI
SMARTER CRC Intervention Year 122
Patient Navigation Completed (Intervention Group) Secondary · Up to 12 months

Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).

GroupValue95% CI
SMARTER CRC Intervention Year 122
Follow-up Colonoscopy Completion Secondary · Up to 12 months

The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months

GroupValue95% CI
SMARTER CRC Intervention Year 149.1
SMARTER CRC Usual Care19.7
Time to Colonoscopy From Abnormal FIT Result Secondary · Up to 12 months

Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.

GroupValue95% CI
SMARTER CRC Intervention Year 196.372.6 – 119.9
SMARTER CRC Usual Care114.650.0 – 179.2
Adenomas or Cancers Detected Secondary · Up to 12 months

Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.

Adenomas
GroupValue95% CI
SMARTER CRC Intervention Year 17
Usual Care14
Cancers
GroupValue95% CI
SMARTER CRC Intervention Year 11
Usual Care4
Key Implementation Barriers Secondary · Up to 36 months

Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers.

COVID disruptions
GroupValue95% CI
SMARTER CRC Intervention and Usual Care Year 14
Staffing Disruptions
GroupValue95% CI
SMARTER CRC Intervention and Usual Care Year 119
Mailing Delays
GroupValue95% CI
SMARTER CRC Intervention and Usual Care Year 15
Did Not Mention
GroupValue95% CI
SMARTER CRC Intervention and Usual Care Year 154

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Coronado GD, Leo MC, Ramsey K, Coury J, et al · · 2022 · cited 17× · PMID 35418107 · DOI 10.1186/s43058-022-00285-3
  2. Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative.
    Coronado GD, Ferrari RM, Barnes A, Castañeda SF, et al · · 2023 · cited 16× · PMID 36810931 · DOI 10.1093/jnci/djad032
  3. Mailed Outreach and Patient Navigation for Colorectal Cancer Screening Among Rural Medicaid Enrollees: A Cluster Randomized Clinical Trial.
    Coronado GD, Petrik AF, Leo MC, Coury J, et al · · 2025 · cited 7× · PMID 40094661 · DOI 10.1001/jamanetworkopen.2025.0928
  4. Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas.
    Coury J, Coronado G, Currier JJ, Kenzie ES, et al · · 2024 · cited 6× · PMID 38191536 · DOI 10.1186/s43058-023-00540-1
  5. Adaptations to a patient navigation program for follow-up colonoscopy in rural primary care practices.
    Thompson JH, Rivelli JS, Schneider JL, Kenzie ES, et al · · 2024 · cited 5× · PMID 38935862 · DOI 10.1111/jep.14068
  6. Engaging with Rural Communities for Colorectal Cancer Screening Outreach Using Modified Boot Camp Translation.
    Coury J, Coronado GD, Myers E, Patzel M, et al · · 2024 · cited 5× · PMID 38661826 · DOI 10.1353/cpr.2024.a922329
  7. Current Progress in Clinical Research in Secondary Prevention and Early Detection of Colorectal Cancer.
    Partyka O, Pajewska M, Czerw A, Deptała A, et al · · 2025 · cited 2× · PMID 39941735 · DOI 10.3390/cancers17030367
  8. Effort Required and Lessons Learned From Recruiting Health Plans and Rural Primary Care Practices for a Cancer Screening Outreach Study.
    Badicke B, Coury J, Myers E, Petrik AF, et al · · 2024 · cited 2× · PMID 38864248 · DOI 10.1177/21501319241259915

Verify or expand the search:

Other trials of Fecal Immunochemical Test

Trials testing the same drug.

Other recruiting trials for Colorectal Carcinoma

Currently open trials in the same condition.

Other OHSU Knight Cancer Institute trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04890054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing