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The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proactive Screening Outreach | Experimental | Participants assigned to the interventional arm will receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer. |
|
| Standard of Care | No Intervention | Participants assigned to the standard of care group will receive usual care (i.e., opportunistic screening for colorectal cancer). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Screening Outreach | Behavioral | Individuals in the interventional arm will receive an information letter, followed by mailed FIT kit. Individuals that do not respond will receive reminder phone calls. Individuals that do respond will receive navigation to assist with completion of FIT and the colonoscopy if FIT is abnormal. Clinic processes will be closely followed and the primary care provider will be informed of the program. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants who Complete FIT Test by Month 6 | Up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6 | Up to Month 6 |
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Inclusion Criteria:
Patients
Providers
Exclusion Criteria:
Providers
• No longer employed at an included clinic site
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| Name | Affiliation | Role |
|---|---|---|
| Aasma Shaukat | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Brooklyn | New York | 11203 | United States | ||
| Community Health Care Network of New York |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Aasma.Shaukat@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Aasma.Shaukat@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Brooklyn |
| New York |
| 11206 |
| United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |