Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients
Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
2 other identifiers
interventional
921
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
February 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2024
CompletedResults Posted
Study results publicly available
June 5, 2025
CompletedJune 5, 2025
June 1, 2025
2 months
January 28, 2024
June 1, 2025
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test
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 Outcomes (1)
Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App
28 days
Study Arms (4)
Text message 1
EXPERIMENTALVersion 1 of the text message invitation to use the cloud-based colorectal cancer screening program
Text message 2
EXPERIMENTALVersion 2 of the text message invitation to use the cloud-based colorectal cancer screening program
Text message 3
EXPERIMENTALVersion 3 of the text message invitation to use the cloud-based colorectal cancer screening program
Text message 4
EXPERIMENTALVersion 4 of the text message invitation to use the cloud-based colorectal cancer screening program
Interventions
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Digital Health Navigation Solutions, Inclead
- Wake Forest University Health Sciencescollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Results Point of Contact
- Title
- Dr. Anna Snavely
- Organization
- Wake Forest University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
David Miller, MD, MS
Digital Health Navigation Solutions, Inc
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2024
First Posted
February 5, 2024
Study Start
February 5, 2024
Primary Completion
March 26, 2024
Study Completion
March 26, 2024
Last Updated
June 5, 2025
Results First Posted
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Individual participant data (IPD) and supporting information will be available beginning 6 months and ending 36 months following article publication.
- 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).
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.