Proactive Outreach With FIT

NCT ID: NCT06269744

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Proactive Screening Outreach

Participants assigned to the interventional arm will receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer.

Group Type EXPERIMENTAL

Proactive Screening Outreach

Intervention Type 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.

Standard of Care

Participants assigned to the standard of care group will receive usual care (i.e., opportunistic screening for colorectal cancer).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Proactive Screening Outreach

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Patients

* Men and women aged 45-75
* Receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites.
* Due or overdue for CRC screening.
* Medical visit of any type at clinic in past year.

Providers

* Physicians or primary care givers at Flatbush FHC or CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites (CHN employees)
* Provide care to CRC screen-eligible patients

Exclusion Criteria

* Age younger than 45 years old or greater than 75 years old
* Up-to-date with colorectal cancer screening:
* History of colorectal cancer, inflammatory bowel disease, colorectal polyps, or total colectomy
* In hospice care
* Patients 66 years or older living long-term in an institution or with advanced illness
* No address or phone number on file

Providers

• No longer employed at an included clinic site
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aasma Shaukat

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

Brooklyn, New York, United States

Site Status

Community Health Care Network of New York

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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23-01032

Identifier Type: -

Identifier Source: org_study_id

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