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

NCT06052202 | Completed Results

• 1 other identifier: R44CA246899
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Received a Colorectal Cancer Screening Test

  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.

  Month 6

• Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test

  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.

  baseline, 6-months

Secondary Outcomes (5)

• Perceived Severity of Colorectal Cancer at Month 6

  Month 6

• Perceived Susceptibility to Colorectal Cancer at Month 6

  Month 6

• Perceived Benefits to Colonoscopy at Month 6

  Month 6

• Perceived Benefits to Stool Test at Month 6

  Month 6

• Colorectal Cancer Knowledge at Month 6

  Month 6

Study Arms (2)

CRC mHealth intervention

EXPERIMENTAL

Experimental group participants will have access to the CRC mHealth intervention.

Behavioral: CRC mHealth

Control Education

ACTIVE COMPARATOR

Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.

Behavioral: Control

Interventions

Control BEHAVIORAL

Participants receive text messages that include links to videos and/or brochures developed by the Centers for Disease Control. This information is designed to educate the public about colorectal cancer and motivate screening. Text messages are sent every 2-3 days for 6 weeks.

Control Education

CRC mHealth BEHAVIORAL

Participants receive text messages that contain information about colorectal cancer and screening. Some text messages include links to videos that are intended to reduce barriers to colorectal cancer screening. Other text messages include links to brief web-based assessments. Responses to assessment questions are used to make sure each man receives only the information relevant to his needs. The main educational content is completed in the first 6 weeks. Additional educational and motivation text messages continue for up to 4 more months if a participant reports not having completed colorectal cancer screening.

CRC mHealth intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American/Black
• not compliant with current United States Preventive Services Taskforce colorectal cancer screening recommendations
• owns a mobile phone capable of text messaging and accessing webpages
• able to speak/understand English

You may not qualify if:

• personal history of colorectal cancer

Sponsors & Collaborators

• ISA Associates, Inc.: lead

Study Sites (1)

ISA Associates, Inc.

Alexandria, Virginia, 22314, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

The planned primary outcome -EHR-verified CRC screening - could not be assessed due to failed record linkage. The clinic initially confirmed that name and phone number would suffice, but immediately before extraction FMCS required additional identifiers (e.g., date of birth) to match most records. Despite multiple attempts at alternative matching, linkage remained inadequate, leaving the EHR data unusable for the endpoint. We therefore report survey-based proxy composite outcomes.

Results Point of Contact

• Title: Samantha Leaf, PhD
• Organization: ISA Associates, Inc.

sleaf@isagroup.com

7037390883

Study Officials

• Samantha L Leaf, Ph.D.

  ISA Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: December 8, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Locations

US (1)