mPATH-Cloud for Colorectal Cancer Screening
mPATH-Cloud
Evaluating a Remotely Delivered, Digital Health CRC Screening Intervention Among Racially Diverse Patients of a Community Health Center
2 other identifiers
interventional
1,062
1 country
2
Brief Summary
This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2). Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address. The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2). This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the intervention phase, Arm 1 receives usual care only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jun 2025
Typical duration for not_applicable colorectal-cancer
2 active sites
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
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
April 30, 2026
April 1, 2026
2 years
May 22, 2024
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal cancer screening completion rate
The proportion of individuals who completed CRC screening using any of the screening modalities recommended by the United States Preventive Service Task Force. Screening modalities could be fecal occult blood test (FIT), fecal occult blood test (FOBT), the stool DNA test combines the FIT ( FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography (CT) colonography.
Up to 6 months
Secondary Outcomes (1)
Colorectal cancer screening up-to-datedness
Up-to-date status assessed 12 months after baseline for unscreened or 12 months after screening completion if screened within 12 months. Total follow-up up to 30 months post-baseline. Round 2 anchored to baseline or screening date if within 12 months.
Study Arms (2)
Trial Mailed FIT Intervention
EXPERIMENTALSubjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™-Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT mailed to their home address.
Trial Usual Care
ACTIVE COMPARATORSubjects randomized to this arm receive usual care. Current usual care at the participating community health centers consists of a visit-based colorectal cancer screening recommendation and referral.
Interventions
Subjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™- Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who select FIT, as well as subjects who do not click on the link or select a screening test receive a FIT mailed to their home address.
The study team will send subjects a prompt to visit the mobile health decision support tool (mPATH™-Cloud). Subjects with a mobile phone (as determined by their electronic health record) will receive a link to mPATH-Cloud by text. Subjects with a mailing address, but no mobile phone number in the EHR, will receive a letter inviting them to access mPATH-Cloud via URL code. Within mPATH-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT.
Eligibility Criteria
You may qualify if:
- Age 45-73 years at time of enrollment
- At average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: documented history in the EHR of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease)
- No record in the EHR of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- No record in the EHR of any CRC diagnosis or total colectomy
- Active patient of the clinic as documented in the EHR (seen at least 2 times within the past 12 months)
- For the second and third study rounds only: No record of a positive (abnormal) CRC screening result in a previous study round
You may not qualify if:
- Age younger than 45 years or older than 73 years at the time of enrollment
- Not at average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease)
- Colorectal carcinoma screening in last 12 months Record in the electronic health record (HER) of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- Record in the EHR any CRC diagnosis or total colectomy
- Not an active client of the clinic as documented in the EHR (not seen at least 2 times within the past 12 months)
- For second and third annual study rounds only: Record of a positive (abnormal) CRC screening result in a previous study round
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNC Lineberger Comprehensive Cancer Centerlead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
Frerichs L, Zhang Z, Moore AA, Falk I, Tan X, Randazzo A, Brenner AT, S Reuland D, Dharod A, Miller DP Jr. Using a digital health platform to implement a multi-component CRC screening intervention within a federally qualified health center: study protocol for a hybrid type I trial. BMC Health Serv Res. 2025 Aug 8;25(1):1047. doi: 10.1186/s12913-025-13262-y.
PMID: 40781671DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leah M Frerichs, PhD
UNC Lineberger Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
June 4, 2024
Study Start
June 24, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2029
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
All of the participant data collected during the trial, after de-identification, will be made available. IPD Sharing Supporting Information Type: Study Protocol, SAP, and Analytic Code. IPD Sharing Time Frame: Beginning 6 months after summary data are published or otherwise made available with no end date. IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to leahf@unc.edu.