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Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

NCT06821009 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6500

Last updated 2026-04-23

No results posted yet for this study

Summary

mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based care setting; and (2) determine the value generated by mPATH in each healthcare setting.

Conditions

  • Colorectal Cancer Screening

Interventions

OTHER

mPATH-CRC

Individuals will receive an automated text message inviting them to use the mPATH-CRC WebApp. The WebApp takes approximately 5 to 8 minutes to complete. The WebApp verifies patients are due for routine CRC screening, educates them about their options, and lets them request a screening test via the program.

OTHER

Usual Care (Control)

Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening. In the participating Fee-for-Service and Value-Based settings, the EHR flags patients who are overdue for CRC screening as a "care gap" that is visible to all primary care providers.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Digital Health Navigation Solutions, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06821009 on ClinicalTrials.gov