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Clinical Trials/NCT06052202
NCT06052202
Completed
N/A

Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve Screening Among African American Men

ISA Associates, Inc.1 site in 1 country128 target enrollmentDecember 8, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
ISA Associates, Inc.
Enrollment
128
Locations
1
Primary Endpoint
Percentage of Participants Who Received a Colorectal Cancer Screening Test
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 8, 2023
End Date
May 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • personal history of colorectal cancer

Outcomes

Primary Outcomes

Percentage of Participants Who Received a Colorectal Cancer Screening Test

Time Frame: 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.

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

Time Frame: 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.

Secondary Outcomes

  • 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)
  • Perceived Severity of Colorectal Cancer at Month 6(Month 6)
  • Perceived Susceptibility to Colorectal Cancer at Month 6(Month 6)

Study Sites (1)

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