NCT05341622

Mailed FIT Outreach 2022

Completed NA Results posted Last updated 24 July 2024

What this trial tests

NA trial testing Differentiated Box in Colorectal Cancer in 5,460 participants. Completed in 13 December 2022.

Timeline

27 May 2022

Primary endpoint
13 October 2022

13 December 2022

Quick facts

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	prevention
Enrollment	5,460
Start date	27 May 2022
Primary completion	13 October 2022
Estimated completion	13 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Differentiated Box
• Standard Mail
• Text
• No Text
• Reminder
• No Reminder

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colon Cancer — all drugs for Colon Cancer →

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

Adults 50 to 74, any sex, with Colorectal Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

FIT Completion Primary · 4 months

Percent of patients who complete FIT

Group	Value	95% CI
Box (Arms 1+2+3+4)	469
Envelope (Arms 5+6+7+8)	470
Text (Arms 1+2+5+6)	558
No Text (Arms 3+4+7+8)	381
Reminder (Arms 1+3+5+7)	532
No Reminder (Arms 2+4+6+8)	407

FIT Completion Secondary · 6 months

Percent of patients who complete FIT

Group	Value	95% CI
Box (Arms 1+2+3+4)	506
Envelope (Arms 5+6+7+8)	492
Text (Arms 1+2+5+6)	593
No Text (Arms 3+4+7+8)	405
Reminder (Arms 1+3+5+7)	559
No Reminder (Arms 2+4+6+8)	439

Colorectal Cancer (CRC) Screening Completion (Any) Secondary · 6 months

Percent of patients who complete any CRC screening

Group	Value	95% CI
Box (Arms 1+2+3+4)	650
Envelope (Arms 5+6+7+8)	640
Text (Arms 1+2+5+6)	739
No Text (Arms 3+4+7+8)	551
Reminder (Arms 1+3+5+7)	700
No Reminder (Arms 2+4+6+8)	590

FIT Positive Follow-up Scheduling Secondary · 6 months

Percent of patients with FIT+ results that schedule a colonoscopy

Group	Value	95% CI
Patients With a Positive FIT Result	26

FIT Positive Follow-up Completion Secondary · 6 months

Percent of patients with FIT+ results that complete a diagnostic colonoscopy

Group	Value	95% CI
Patients With a Positive FIT Result	23

Sponsor's own description

This project aims to evaluate different approaches to increase colorectal cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase response rate to mailed fecal immunochemical test (FIT) kits among eligible patients, including differentiated packaging, sending text reminders, and personalized reminders.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Behavioral Interventions Improve Mailed Colorectal Cancer Screening Among Overdue Patients in a Randomized Trial.
   Mehta SJ, Nadella P, Shaw PA, Reitz C, et al · · 2026 · cited 1× · PMID 40983155 · DOI 10.1016/j.cgh.2025.09.015