NCT06805383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,135

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

January 13, 2025

Last Update Submit

June 3, 2025

Conditions

Colorectal Cancer Screening

Keywords

fecal immunochemical tests (FIT)cancer screeningNurse follow-up

Outcome Measures

Primary Outcomes (1)

  • Return Rate

    FIT Kit returned to health system for processing.

    60 Days

Study Arms (2)

FIT Kit Only

ACTIVE COMPARATOR

Patients sent a second FIT Kit.

Other: Mailed FIT Kit

FIT Kit + Phone Call

EXPERIMENTAL

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

Behavioral: Phone callOther: Mailed FIT Kit

Interventions

Phone callBEHAVIORAL

Phone call to patients randomized to experimental arm.

FIT Kit + Phone Call
Mailed FIT KitOTHER

FIT Kit mailed to patient address in EMR.

FIT Kit + Phone CallFIT Kit Only

Eligibility Criteria

Age45 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 45-59
  • Due for colorectal cancer screening
  • Not sent a FIT Kit in the past 3-months
  • Previously returned a FIT Kit.

You may not qualify if:

  • Under age 45 or over age 59;
  • incarcerated;
  • not due for colorectal cancer screening
  • sent a FIT Kit in the past 3-months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Contra Costa Health Services

Martinez, California, 94553, United States

Location

Contra Costa Health

Martinez, California, 94553, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 3, 2025

Study Start

October 16, 2024

Primary Completion

January 31, 2025

Study Completion

March 31, 2025

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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

Locations

US(2)