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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052202
• Other study ID #: R44CA246899
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: ISA Associates, Inc.
• Contact: Samantha L Leaf, Ph.D.
• Phone: 7037390880
• Email: sleaf[@]isagroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	ISA Associates, Inc.	Alexandria	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ISA Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of Colorectal Cancer Screening Test at Month 6	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 medical 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.	Month 6
Secondary	Change from Baseline in Perceived Severity of Colorectal Cancer at 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 0 to 4 with higher scores indicating higher perceived severity.	Baseline and Month 6
Secondary	Change from Baseline in Perceived Susceptibility to Colorectal Cancer at 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 0 to 4 with higher scores indicating higher perceived susceptibility.	Baseline and Month 6
Secondary	Change from Baseline in Perceived Benefits to Colonoscopy at Month 6	Measured using Rawl and colleagues' (2001) 5-item perceived benefits to colonoscopy scale. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher perceived benefits to colonoscopy.	Baseline and Month 6
Secondary	Change from Baseline in Perceived Benefits to Stool Test at 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 0 to 4 with higher scores indicating higher perceived benefits to stool tests.	Baseline and Month 6
Secondary	Change from Baseline in Cancer Fatalism at Month 6	Measured using the 15-item Powe Fatalism Inventory. Items are averaged to form a score ranging from 0 to 4 with higher scores indicating higher cancer fatalism beliefs.	Baseline and Month 6
Secondary	Change from Baseline in Colorectal Cancer Knowledge at 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.	Baseline and Month 6