Additional Mailed FIT Kits

NCT ID: NCT06805370

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-31

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.

Conditions

Colorectal Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Mailed Additional FIT Kit

This arm was sent a follow-up FIT Kit in November 2024 in addition to the annual FIT Kit mailing.

Group Type: EXPERIMENTAL

Mailed Additional FIT Kit

Intervention Type: BEHAVIORAL

Mailed additional FIT Kits in November 2024.

Interventions

Mailed Additional FIT Kit

Mailed additional FIT Kits in November 2024.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Mireille Jacobson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Contra Costa Health

Martinez, California, United States

Countries

United States

Other Identifiers

CCHS-QIP-SECOND-FIT-KIT

Identifier Type: -

Identifier Source: org_study_id