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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: CRC mHealth; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha L Leaf, Ph.D.; Phone Number: 4 7037390880; Email: sleaf@isagroup.com
• Study Contact Backup: Name: Douglas Billings, Ph.D.; Phone Number: 3 7037390880; Email: dbillings@isagroup.com

Study Locations

• United States
  • Virginia
    • Alexandria, Virginia, United States, 22314
      • Recruiting
      • ISA Associates, Inc.
      • Contact: Samantha Leaf, Ph.D.; Phone Number: 4 703-739-0880; Email: sleaf@isagroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRC mHealth intervention; Experimental group participants will have access to the CRC mHealth 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.
Active Comparator: Control Education; Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: ISA Associates, Inc.
• Investigators: Principal Investigator: Samantha L Leaf, Ph.D., ISA Associates

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: R44CA246899 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No