Clinical trial NCT06052202: A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men
Official title: Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve Screening Among African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: ISA Associates, Inc.
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 128
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Receipt of Colorectal Cancer Screening Test at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Change from Baseline in Perceived Severity of Colorectal Cancer at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline in Perceived Susceptibility to Colorectal Cancer at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline in Perceived Benefits to Colonoscopy at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline in Perceived Benefits to Stool Test at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline in Cancer Fatalism at Month 6
timeFrame: Baseline and Month 6
measure: Change from Baseline in Colorectal Cancer Knowledge at Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: ISA Associates, Inc.
state: Virginia
Study officials:
affiliation: ISA Associates
name: Samantha L Leaf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: