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

February 5, 2024 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

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 Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157

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
Other: mPATH-CRC Web app
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
Other: mPATH-CRC Web app
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
Other: mPATH-CRC Web app
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
Other: mPATH-CRC Web app
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
Proportion of participants who request a colorectal cancer (CRC) screening test
Time Frame: 28 days
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
Proportion of participants who complete the mPATH-CRC Web App
Time Frame: 28 days
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.

Sponsor

Digital Health Navigation Solutions, Inc

Collaborators

National Cancer Institute (NCI)
Wake Forest University Health Sciences

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 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 (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

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.

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