Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients
June 4, 2025 updated by: Digital Health Navigation Solutions, Inc
Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
921
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Atrium Health Wake Forest Baptist
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Text message 1
Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program
|
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
|
|
Experimental: Text message 2
Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program
|
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
|
|
Experimental: Text message 3
Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program
|
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
|
|
Experimental: Text message 4
Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program
|
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test
Time Frame: 28 days
|
Number (and 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App
Time Frame: 28 days
|
Number (and 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Miller, MD, MS, Digital Health Navigation Solutions, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2024
Primary Completion (Actual)
March 26, 2024
Study Completion (Actual)
March 26, 2024
Study Registration Dates
First Submitted
January 28, 2024
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Estimated)
June 5, 2025
Last Update Submitted That Met QC Criteria
June 4, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93476
- R42CA275665 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The investigators will share the data dictionary and de-identified individual participant data that underlie our published results with researchers who provide a methodologically sound proposal.
Use of the data will be limited to achieve the aims in their submitted proposal.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Time Frame
Individual participant data (IPD) and supporting information will be available beginning 6 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal will be provided the data dictionary and deidentified participant data that underlie published study results.
Use of the data will be limited to achieve the aims in their submitted proposal.
To gain access, data requestors will need to sign a data access agreement.
Researchers desiring IPD access should email requests to the study PI, Dr. David Miller (dave@mpathhealth.com).
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.