Randomized Trial of Follow-up to Mailed FIT Kits

University of Southern California

Status: Completed

Conditions: Colorectal Cancer Screening

Treatments: Other: Mailed FIT Kit; Behavioral: Phone call

Study type: Interventional

Funder types: Other

Identifiers

NCT06805383

CCHS-QIP-FOLLOWUP-FIT-KIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,135 patients

Sex: All

Ages: 45 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,135 participants in 2 patient groups

FIT Kit Only

Active Comparator group

Description:

Patients sent a second FIT Kit.

Treatment:

Other: Mailed FIT Kit

FIT Kit + Phone Call

Experimental group

Description:

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

Treatment:

Behavioral: Phone call

Other: Mailed FIT Kit