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

NCT06821009 | Active Not Recruiting

• 2 other identifiers: IRB001182364R42CA275665
• Study Type: interventional
• Target: 6,500
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of mPATH-CRC

  The proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms

  180 Days

Secondary Outcomes (6)

• Reach of mPATH-CRC

  30 Days

• Reporting current CRC screening

  30 Days

• CRC screening ordered

  180 Days

• Colorectal Neoplasia

  180 days

• Mean revenue generated in a Fee-for-Service setting

  365 Days

Study Arms (2)

mPATH-CRC

EXPERIMENTAL

Participants randomized to the mPATH arm will receive a text message inviting them to use the mPATH-CRC WebApp. The WebApp verifies individuals are due for routine colorectal cancer (CRC) screening, educates them about their options, and lets them request a screening test via the program.

Other: mPATH-CRC

Usual Care (Control)

PLACEBO COMPARATOR

Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening.

Other: Usual Care (Control)

Interventions

mPATH-CRC OTHER

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.

mPATH-CRC

Usual Care (Control) OTHER

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.

Usual Care (Control)

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-74 years
• Be identified in the electronic health record as due for routine CRC screening, defined as
• No colonoscopy in prior 10 years
• No flexible sigmoidoscopy in prior 5 years
• No CT colography in prior 5 years
• No FIT-DNA test (Cologuard) within prior 3 years
• No Fecal Occult Blood Test within prior 1 year
• Have a cell phone number listed in the EHR
• Have a preferred language of English or Spanish in the EHR
• Upcoming appointment within 9 to 16 days
• Georgia Market Only: Insurance type is listed as Medicare Advantage.

You may not qualify if:

• Prior diagnosis of colorectal cancer
• Prior history of total colectomy
• Currently enrolled in palliative care or Hospice
• Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
• Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)

Sponsors & Collaborators

• Digital Health Navigation Solutions, Inc: lead
• National Cancer Institute (NCI): collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (2)

Atrium Health Floyd

Rome, Georgia, 30161, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within one year of the publication of the study's results. Data will be kept available until 4 years after the publication of the study's results.
• Access Criteria: Researchers must provide the investigative team 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.

Locations

US (2)