Additional Mailed FIT Kits

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

Randomized Trial of Additional Mailed FIT Kits

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1700

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

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care (Annual FIT Kit Only)
This arm was sent an annual FIT Kit but was not sent a follow-up FIT Kit in November 2024.
Other: Usual Care
This group was sent an annual FIT Kit per usual care.
Experimental: Mailed Additional FIT Kit
This arm was sent a follow-up FIT Kit in November 2024 in addition to the annual FIT Kit mailing.
Behavioral: Mailed Additional FIT Kit
Mailed additional FIT Kits in November 2024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FIT Kit return rate
Time Frame: 60-Days
Indicator of whether a patient successfully returned a FIT Kit to the 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)

November 1, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

January 15, 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-SECOND-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.

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