NCT06052202

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men

Completed NA Results posted Last updated 2 January 2026

What this trial tests

NA trial testing CRC mHealth in Colorectal Cancer in 128 participants. Completed in 1 May 2025.

Timeline

8 December 2023

Primary endpoint
1 May 2025

1 May 2025

Quick facts

Lead sponsor	ISA Associates, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	128
Start date	8 December 2023
Primary completion	1 May 2025
Estimated completion	1 May 2025
Sites	1 location across United States

Drugs / interventions tested

• CRC mHealth
• Control

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

ISA Associates, Inc.

Who can join

Adults 45 to 75, male only, with Colorectal 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.

Percentage of Participants Who Received a Colorectal Cancer Screening Test Primary · Month 6

This measure assesses whether or not a participant received a colorectal cancer screening test since beginning the study. The date and type of screening will be verified via electronic health records. A value of "0" will be recorded if no screening test is found in the electronic health record. A value of "1" will be recorded if a screening test is found in the electronic health record. The percentage of participants with a electronic health record verified screening will be calculated from these values.

Group	Value	95% CI
CRC mHealth Intervention	2
Control Education	2

Perceived Severity of Colorectal Cancer at Month 6 Secondary · Month 6

Measured using the 12-item perceived severity subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived severity.

Group	Value	95% CI
CRC mHealth Intervention	2.82	± 0.76
Control Education	2.59	± 0.61

Perceived Susceptibility to Colorectal Cancer at Month 6 Secondary · Month 6

Measured using the 5-item perceived susceptibility subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived susceptibility.

Group	Value	95% CI
CRC mHealth Intervention	2.82	± 0.76
Control Education	2.59	± 0.61

Perceived Benefits to Colonoscopy at Month 6 Secondary · Month 6

Measured using Rawl and colleagues' (2001) 5-item perceived benefits to colonoscopy scale. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived benefits to colonoscopy.

Group	Value	95% CI
CRC mHealth Intervention	4.23	± 0.51
Control Education	4.11	± 0.54

Perceived Benefits to Stool Test at Month 6 Secondary · Month 6

Measured using Rawl and colleagues' (2001) 5-item perceived benefits to fecal occult blood test scale. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived benefits to stool tests.

Group	Value	95% CI
CRC mHealth Intervention	3.91	± 0.52
Control Education	4.06	± 0.52

Colorectal Cancer Knowledge at Month 6 Secondary · Month 6

Measured using the 16-item CRC Knowledge test subsection of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. The true/false items are scored 1 (correct) or 0 (incorrect) and summed to form a score ranging from 0 to 16. Higher scores indicate greater colorectal cancer knowledge.

Group	Value	95% CI
CRC mHealth Intervention	13.70	± 1.49
Control Education	13.17	± 1.43

Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test Primary · baseline, 6-months

Participants responded to a multiple-choice item asking whether they had completed a recommended colorectal cancer screening (colonoscopy, FIT, FIT-DNA, virtual colonoscopy, or flexible sigmoidoscopy) in the past 6 months. Response options were Yes/No/I'm not sure.

Group	Value	95% CI
CRC mHealth Intervention	40.4	27.6 – 54.7
Control Education	17.0	8.9 – 30.1

Sponsor's own description

The goal of this clinical trial is to test a new smartphone-based program designed to help African American men get screened for colorectal cancer (CRC). The main question it aims to answer is:

° Are African American men who complete the smartphone-based program more likely to get screened for colorectal cancer than men who do not?

Participants will:

* Complete a baseline survey asking about their colorectal cancer screening history and their thoughts and beliefs about colorectal cancer and the medical system.
* Be randomized to receive the new smartphone-based program or to receive text messages containing colorectal cancer education materials designed by the Centers for Disease Control (CDC). The new program sends text messages with information about colorectal cancer. Some of these text messages have links to videos that try to help men overcome anything that may stand in the way of getting screened.
* Complete a follow-up survey 6 months after the baseline survey. This survey will ask the same questions as the baseline survey.
* A medical records review will be conducted at 6 months to verify whether participants received a colorectal cancer screening test during the study period.

Researchers will compare participants who receive the new smartphone-based program to participants who receive the CDC information. The goal is to see whether the smartphone-based program increasing screening more than standard educational materials available on the internet.

Publications & conference data

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

1. Current Progress in Clinical Research in Secondary Prevention and Early Detection of Colorectal Cancer.
   Partyka O, Pajewska M, Czerw A, Deptała A, et al · · 2025 · cited 2× · PMID 39941735 · DOI 10.3390/cancers17030367