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NCT06241768 Clinical Trial

Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients

Colorectal Cancer Screening Clinical Trial

Official title:
Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06241768
Other study ID # 93476
Secondary ID R42CA275665
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date June 2024

Study information
Verified date February 2024
Source Digital Health Navigation Solutions, Inc
Contact Elena Wright, MS
Phone 1-336-713-3103
Email eswright@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are: - Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program? - How many patients will respond to a text message intervention to use the web app? Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program. Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - Have a phone number listed in the electronic health record - Language preference of English in the electronic health record - Have a scheduled primary care appointment within the next 15 days Exclusion Criteria: - Prior diagnosis of colorectal cancer - Prior diagnosis of inflammatory bowel disease - Have a record in the electronic health record of completing a colonoscopy within the last 10 years, a FIT-DNA test within the last 3 years, or a fecal immunochemical test (FIT) within the last 1 year - Have an electronic Charlson Comorbidity Index > 2

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• mPATH-CRC Web app
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening

Locations
Country Name City State
United States Atrium Health Wake Forest Baptist Winston-Salem North Carolina

Sponsors (3)
Lead Sponsor Collaborator
Digital Health Navigation Solutions, Inc National Cancer Institute (NCI), Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants who request a colorectal cancer (CRC) screening test Proportion of participants who are confirmed eligible for CRC screening and request a CRC screening test within the mPATH-CRC Web App 28 days
Secondary Proportion of participants who complete the mPATH-CRC Web App Proportion of participants who complete the CRC screening eligibility questions within 4 weeks of the initial invitation using the mPATH-CRC Web App 28 days
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