Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA233848-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Care Clinics | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal Cancer Toolkit | Other | The intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of referrals for colonoscopies after positive fecal immunochemical test | Completion of follow-up (estimated to be 44 months) | |
| Number of colonoscopy completions after positive fecal immunochemical test | -Within 60 days of referral | Completion of follow-up (estimated to be 44 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to colonoscopy | Completion of follow-up (estimated to be 44 months) | |
| Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test | Completion of follow-up (estimated to be 44 months) |
Not provided
Inclusion Criteria for Primary Care Clinic Sites
Exclusion Criteria for Primary Care Clinic Sites
Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
Inclusion Criteria for Patients
Exclusion Criteria for Patients
Inclusion Criteria for Community Members
Exclusion Criteria for Community Members
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aimee James, Ph.D., MPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2025 | |
| Reset | Dec 4, 2025 | |
| Release | Dec 16, 2025 | |
| Reset | Jan 9, 2026 | |
| Release | Jan 29, 2026 | |
| Reset | Feb 17, 2026 | |
| Release | Jun 11, 2026 | |
| Reset | Jul 8, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2020 | Oct 18, 2025 | ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2025 | Dec 4, 2025 | |||
| Dec 16, 2025 |
This is a stepped wedge trial where clusters of sites sequentially enter the intervention. Independent samples of patients are enrolled within a cluster at each set interval of time thus, it is analyzed as a repeated cross-sectional study.
Not provided
Not provided
Not provided
Not provided
|
| Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test | Completion of follow-up (estimated to be 44 months) |
| Jan 9, 2026 |
| Jan 29, 2026 | Feb 17, 2026 |
| Jun 11, 2026 | Jul 8, 2026 |
| Jul 9, 2026 |