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Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits

NCT03718221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8653

Last updated 2021-11-30

No results posted yet for this study

Summary

This is a pragmatic, randomized, controlled trial of a geographically randomized intervention in which all eligible patients will receive a mailed fecal immunochemical test (FIT) kit (the GeoMail study). In this study, all ZIP Codes in Dallas County will be randomized to either treatment or usual care. Patients in treated neighborhoods will receive kits at the same time; patients in usual care neighborhoods will receive FIT kits randomly throughout the year. All eligible patients will receive a FIT kit each year. The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system. This study represents a pragmatic adaptation to the "FIT first" population health screening strategy in which all eligible patients are mailed FIT kits. All patients will also have access to whatever colorectal cancer (CRC) screening is recommended through usual visit-based care.

Conditions

Interventions

OTHER

Usual Care FIT Screening Strategy

Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.

OTHER

GeoMail FIT Screening Strategy

Patients in treated neighborhoods will receive kits at the same time.

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • Parkland Health and Hospital System

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Sandi Pruitt, PhD · UT Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2021-08-30
Completion
2021-08-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718221 on ClinicalTrials.gov