Randomized Trial of Follow-up to Mailed FIT Kits

NCT ID: NCT06805383

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2025-03-31

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.

Conditions

Colorectal Cancer Screening

Study Design

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

Study Groups

FIT Kit Only

Patients sent a second FIT Kit.

Group Type: ACTIVE_COMPARATOR

Mailed FIT Kit

Intervention Type: OTHER

FIT Kit mailed to patient address in EMR.

FIT Kit + Phone Call

Patients sent a second FIT Kit and follow-up call to encourage completion and return of kit.

Group Type: EXPERIMENTAL

Phone call

Intervention Type: BEHAVIORAL

Phone call to patients randomized to experimental arm.

Mailed FIT Kit

Intervention Type: OTHER

FIT Kit mailed to patient address in EMR.

Interventions

Phone call

Phone call to patients randomized to experimental arm.

Intervention Type: BEHAVIORAL

Mailed FIT Kit

FIT Kit mailed to patient address in EMR.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 59 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 Services

Martinez, California, United States

Contra Costa Health

Martinez, California, United States

Countries

United States

Other Identifiers

CCHS-QIP-FOLLOWUP-FIT-KIT

Identifier Type: -

Identifier Source: org_study_id