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

NCT ID: NCT06052202

Last Updated: 2026-01-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-08

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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CRC mHealth intervention

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

Group Type EXPERIMENTAL

CRC mHealth

Intervention Type 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.

Control Education

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type 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.

Interventions

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CRC mHealth

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.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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ISA Associates, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samantha L Leaf, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

ISA Associates

Locations

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ISA Associates, Inc.

Alexandria, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R44CA246899

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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