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Randomized Trial of Follow-up to Mailed FIT Kits

Follow-up to Mailed FIT Kits

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06805383
Enrollment
2135
Registered
2025-02-03
Start date
2024-10-16
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 tests (FIT), cancer screening, Nurse follow-up

Brief summary

This study aims to assess whether follow-up calls can increase the return rate of mailed FIT Kits. To assess this, a randomly selected half of eligible patients were randomized to receive a follow-up call reminding the patient to return the FIT Kit.

Detailed description

This study aims to assess whether follow-up calls can increase the return rate of mailed FIT Kits. Patients ages 45 to 59 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 sent a FIT Kit in October of 2024. Half of patients were randomized to receive a follow-up call reminding the patient to return the FIT Kit. This work analyzes the return rate of the mailed FIT Kit, with or without phone call follow-up.

Interventions

BEHAVIORALPhone call

Phone call to patients randomized to experimental arm.

OTHERMailed FIT Kit

FIT Kit mailed to patient address in EMR.

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
45 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* Age 45-59 * Due for colorectal cancer screening * Not sent a FIT Kit in the past 3-months * Previously returned a FIT Kit.

Exclusion criteria

* Under age 45 or over age 59; * incarcerated; * not due for colorectal cancer screening * sent a FIT Kit in the past 3-months

Design outcomes

Primary

MeasureTime frameDescription
Return Rate60 DaysFIT Kit returned to health system for processing.

Countries

United States

Outcome results

None listed

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