Randomized Trial of Follow-up to Mailed FIT Kits

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.

Completed

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Key information

Conditions

Colorectal Cancer Screening

Age range

45 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contra Costa Health, Martinez, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phone call

Behavioral

Phone call to patients randomized to experimental arm.

Mailed FIT Kit

Other

FIT Kit mailed to patient address in EMR.

Primary outcomes

Return Rate

Time frame: 60 Days

FIT Kit returned to health system for processing.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Follow-up to Mailed FIT Kits

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 3, 2025
Registry last updated: Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed