Randomized Trial of Follow-up to Mailed FIT Kits

June 3, 2025 updated by: Mireille Jacobson, University of Southern California

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Martinez, California, United States, 94553
        • Contra Costa Health Services
      • Martinez, California, United States, 94553
        • Contra Costa Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FIT Kit Only
Patients sent a second FIT Kit.
Other: Mailed FIT Kit
FIT Kit mailed to patient address in EMR.
Experimental: FIT Kit + Phone Call
Patients sent a second FIT Kit and follow-up call to encourage completion and return of kit.
Other: Mailed FIT Kit
FIT Kit mailed to patient address in EMR.
Behavioral: Phone call
Phone call to patients randomized to experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return Rate
Time Frame: 60 Days
FIT Kit returned to health system for processing.
60 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHS-QIP-FOLLOWUP-FIT-KIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Researchers can apply for permission to use anonymized data from CCHS.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Cancer Screening

Clinical Trials on Mailed FIT Kit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe