Additional Mailed FIT Kits

Randomized Trial of Additional Mailed FIT Kits

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06805370

Enrollment

1700

Registered

2025-02-03

Start date

2024-11-01

Completion date

2025-03-31

Last updated

2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

fecal immunochemical test (FIT), cancer screening

Brief summary

This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, the health system mailed a random subset of patients ages 60 to 75 a FIT Kit in November 2024 in addition to sending patients an annual FIT Kit mailing. This work analyzes the return rate of mailed FIT Kits within 60-days of the November mailing.

Detailed description

This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, patients ages 60 to 75 due for colorectal cancer screening, who had not received a FIT Kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were randomized to be sent a FIT Kit in November of 2024 or to usual care. Usual care includes an annual FIT Kit mailing. We will analyze the successful return rate of mailed FIT Kits within 60-days of the November mailing.

Interventions

BEHAVIORALMailed Additional FIT Kit

Mailed additional FIT Kits in November 2024.

OTHERUsual Care

This group was sent an annual FIT Kit per usual care.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

60 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Age 60-74 * Due for colorectal cancer screening; * Not sent a FIT Kit in the past 3-months; * Previously successfully returned a FIT Kit.

Exclusion criteria

* Under age 60 or over age 74; * Incarcerated; * Not due for colorectal cancer screening; * Sent a FIT Kit in the past 3-months.

Design outcomes

Primary

Measure	Time frame	Description
FIT Kit return rate	60-Days	Indicator of whether a patient successfully returned a FIT Kit to the health system for processing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026