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

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRC mHealth
Control
Sponsored by
ISA Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • ISA Associates, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRC mHealth intervention

Control Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
ISA Associates, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06052202
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ISA Associates, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRC mHealth intervention
Arm Type
Experimental
Arm Description
Experimental group participants will have access to the CRC mHealth intervention.
Arm Title
Control Education
Arm Type
Active Comparator
Arm Description
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Intervention Type
Behavioral
Intervention Name(s)
CRC mHealth
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Receipt of Colorectal Cancer Screening Test at Month 6
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Perceived Severity of Colorectal Cancer at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change from Baseline in Perceived Susceptibility to Colorectal Cancer at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change from Baseline in Perceived Benefits to Colonoscopy at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change from Baseline in Perceived Benefits to Stool Test at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change from Baseline in Cancer Fatalism at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change from Baseline in Colorectal Cancer Knowledge at Month 6
Description
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.
Time Frame
Baseline and Month 6

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha L Leaf, Ph.D.
Phone
7037390880
Ext
4
Email
sleaf@isagroup.com
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas Billings, Ph.D.
Phone
7037390880
Ext
3
Email
dbillings@isagroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha L Leaf, Ph.D.
Organizational Affiliation
ISA Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
ISA Associates, Inc.
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22314
Country
United States

12. IPD Sharing Statement

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

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