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Enrolling by invitation NCT06269744

Proactive Outreach With FIT

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proactive Screening Outreach.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized, Multi-site Trial to Boost Colorectal Cancer Screening Rates Through Proactive Outreach and Navigation in Federally Qualified Health Centers in Brooklyn

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Proportion of Participants who Complete FIT Test by Month 6 [Time frame: Up to Month 6]
Secondary outcome measures (1)
  • Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6 [Time frame: Up to Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • NYU Langone Health — Brooklyn
  • Community Health Care Network of New York — Brooklyn

Identifiers

NCT: NCT06269744 · 23-01032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗