Trial · NCT04890054
Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
NCT04890054, Not applicable, Completed, OHSU Knight Cancer Institute; results first posted 2025-08-19
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC. Trials, record NCT04890054. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04890054
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
- NCT number
- NCT04890054
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,696 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Colorectal Carcinoma
- Interventions
- Fecal Immunochemical Test, Interview, Patient Navigation
- First posted
- 2021-05-18
- Last updated
- 2025-08-19
- Results first posted
- 2025-08-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | 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. |
| Secondary | Completion of CRC Screening | 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). |
| Secondary | Rate of CRC Screening Among the Intervention-eligible Population | 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. |
| Secondary | Time to Screening From Study-eligible Patient List Pull | Up to 12 months | Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level. |
| Secondary | Abnormal FIT Results | 6 months | Number of participants with abnormal FIT Results |
| Secondary | Patient Navigation Trainings (Intervention Group) | Up to 12 months | Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial |
| Secondary | Patient Navigation Completed (Intervention Group) | Up to 12 months | Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level). |
| Secondary | Follow-up Colonoscopy Completion | Up to 12 months | The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months |
| Secondary | Time to Colonoscopy From Abnormal FIT Result | Up to 12 months | Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level. |
| Secondary | Adenomas or Cancers Detected | Up to 12 months | Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | Primary outcome at 6 months following CCO eligible patient list pull date, | Intention to treat, multi-level within clinics. One clinic closed immediately after randomization and before patients could be determined eligible before the intervention began. | Percentage of participants | MEAN |
| SECONDARY | Completion of CRC Screening | Up to 12 months | Intent to treat, multi-level within clinics. One clinic closed after randomization and before the intervention began. | Percentage of participants | MEAN |
| SECONDARY | Rate of CRC Screening Among the Intervention-eligible Population | 6 months | Patients NOT excluded during the clinic scrub, expected for intervention components. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Screening From Study-eligible Patient List Pull | Up to 12 months | Intent to treat eligible patients at clinics | Days | MEAN |
| SECONDARY | Abnormal FIT Results | 6 months | Intent to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Navigation Trainings (Intervention Group) | Up to 12 months | A subset of the total population of clinic staff, who were invited to the patient navigation training | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Navigation Completed (Intervention Group) | Up to 12 months | Patients in intervention clinics eligible for navigation to colonoscopy due to FIT test result or medical factors | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Follow-up Colonoscopy Completion | Up to 12 months | Intention to treat, patients in clinics | Percent of participants | NUMBER |
| SECONDARY | Time to Colonoscopy From Abnormal FIT Result | Up to 12 months | Intention to treat, patients in clinics | Days | MEAN |
| SECONDARY | Adenomas or Cancers Detected | Up to 12 months | Intention to treat, patients in clinics | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | SMARTER CRC Intervention Year 1 | 11.8 | 95% Confidence Interval 10 to 13.5 | Percentage of participants | |
| Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | SMARTER CRC Usual Care | 4.5 | 95% Confidence Interval 3.6 to 5.4 | Percentage of participants | |
| Completion of CRC Screening | SMARTER CRC Intervention Year 1 | 16.8 | 95% Confidence Interval 15.3 to 18.2 | Percentage of participants | |
| Completion of CRC Screening | SMARTER CRC Usual Care | 9 | 95% Confidence Interval 8.0 to 10.0 | Percentage of participants | |
| Rate of CRC Screening Among the Intervention-eligible Population | SMARTER CRC Intervention Year 1 | 181 | Participants | ||
| Time to Screening From Study-eligible Patient List Pull | SMARTER CRC Intervention Year 1 | 118.5 | Standard Deviation 293.9 | Days | |
| Time to Screening From Study-eligible Patient List Pull | SMARTER CRC Usual Care | 103.2 | Standard Deviation 383.2 | Days | |
| Abnormal FIT Results | SMARTER CRC Intervention Year 1 | 19 | Participants | ||
| Abnormal FIT Results | Usual Care | 7 | Participants | ||
| Patient Navigation Trainings (Intervention Group) | SMARTER CRC Intervention Year 1 | 22 | Participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SMARTER CRC Intervention Year 1 | 2,655 | 14 |
| Overall Study | STARTED | SMARTER CRC Usual Care | 3,041 | 14 |
| Overall Study | Patients | SMARTER CRC Intervention Year 1 | 2,613 | 14 |
| Overall Study | Patients | SMARTER CRC Usual Care | 3,001 | 14 |
| Overall Study | Staff | SMARTER CRC Intervention Year 1 | 42 | 14 |
| Overall Study | Staff | SMARTER CRC Usual Care | 40 | 14 |
| Overall Study | COMPLETED | SMARTER CRC Intervention Year 1 | 2,453 | 14 |
| Overall Study | COMPLETED | SMARTER CRC Usual Care | 2,822 | 14 |
| Overall Study | NOT COMPLETED | SMARTER CRC Intervention Year 1 | 202 | 0 |
| Overall Study | NOT COMPLETED | SMARTER CRC Usual Care | 219 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SMARTER CRC Intervention Patients | 0 | 2,613 |
| Total, all-cause mortality | Usual Care Patients | 0 | 3,001 |
| Total, all-cause mortality | Intervention Staff Members | 0 | 42 |
| Total, all-cause mortality | Usual Care Staff Members | 0 | 40 |
| Total, other adverse events | SMARTER CRC Intervention Patients | 0 | 2,613 |
| Total, other adverse events | Usual Care Patients | 0 | 3,001 |
| Total, other adverse events | Intervention Staff Members | 0 | 42 |
| Total, other adverse events | Usual Care Staff Members | 0 | 40 |
| Total, serious adverse events | SMARTER CRC Intervention Patients | 0 | 2,613 |
| Total, serious adverse events | Usual Care Patients | 0 | 3,001 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH3CA244298 | Screening More patients for CRC through Adapting and Refining Targeted Evidence-based Interventions in Rural settings (SMARTER CRC) | DAVIS, MELINDA MARIE; CORONADO, GLORIA D | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2020 to 2023 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SMARTER CRC Intervention Year 1 vs Usual Care: Abnormal FIT Results |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04890054
GET https://conductscience.org/api/trials/v1/NCT04890054/results?page=2