NCT06805370

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 month 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 15, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

fecal immunochemical test (FIT)cancer screening

Outcome Measures

Primary Outcomes (1)

  • FIT Kit return rate

    Indicator of whether a patient successfully returned a FIT Kit to the health system for processing

    60-Days

Study Arms (2)

Usual Care (Annual FIT Kit Only)

ACTIVE COMPARATOR

This arm was sent an annual FIT Kit but was not sent a follow-up FIT Kit in November 2024.

Other: Usual Care

Mailed Additional FIT Kit

EXPERIMENTAL

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

Interventions

Mailed additional FIT Kits in November 2024.

Mailed Additional FIT Kit

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

Usual Care (Annual FIT Kit Only)

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60-74
  • Due for colorectal cancer screening;
  • Not sent a FIT Kit in the past 3-months;
  • Previously successfully returned a FIT Kit.

You may not qualify if:

  • Under age 60 or over age 74;
  • 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 (1)

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
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2025

First Posted

February 3, 2025

Study Start

November 1, 2024

Primary Completion

February 28, 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