NCT06241768

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
921

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

January 28, 2024

Results QC Date

June 1, 2025

Last Update Submit

June 4, 2025

Conditions

Keywords

colorectal cancer screeningpragmatic clinical trialrandomized clinical trialdigital healthfeasibility study

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

EXPERIMENTAL

Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program

Other: mPATH-CRC Web app

Text message 2

EXPERIMENTAL

Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program

Other: mPATH-CRC Web app

Text message 3

EXPERIMENTAL

Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program

Other: mPATH-CRC Web app

Text message 4

EXPERIMENTAL

Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program

Other: mPATH-CRC Web app

Interventions

Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening

Text message 1Text message 2Text message 3Text message 4

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

Title
Dr. Anna Snavely
Organization
Wake Forest University School of Medicine

Study Officials

  • David Miller, MD, MS

    Digital Health Navigation Solutions, Inc

    PRINCIPAL INVESTIGATOR

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

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.

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).
More information

Locations