mPATH-Cloud for Colorectal Cancer Screening

NCT ID: NCT06441487

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2029-01-01

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 3-year intervention phase, Arm 1 receives usual care only.

Detailed Description

Subjects randomized to the Mobile Health Decision Support intervention arm (Arm 2) receive a link to mobile Patient Technology for Health (mPATH™-Cloud), a digital health platform designed to alleviate the implementation burden on clinical teams by automating many key steps in the CRC screening process. If the subject uses mPATH-Cloud to select a screening test, mPATH-Cloud notifies the subject's primary care provider at the FQHC. Subjects who request colonoscopy are then referred by their primary care provider to colonoscopy as appropriate. Subjects who request FIT receive a FIT mailed to their home.

Primary outcome assessment: To assess intervention effectiveness, CRC screening completion within 6 months of randomization (primary outcome) is assessed by EHR chart review. Screening completion is defined as any of the following: colonoscopy completion (regardless of indication); at least one FIT test with a normal FIT result; or diagnostic colonoscopy following an abnormal FIT result.

Secondary outcome assessment: To assess intervention effectiveness on adherence to USPSTF recommendations over time (secondary outcome), the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review.

CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years. FIT should be repeated annually, and colonoscopy typically only needs to be repeated once every 10 years. Thus, subjects will be assigned one year per annual FIT completed (e.g., FIT in years 1, 2, and 3 would be assigned 3 years; FIT in year 1, and 3 would be assigned 2 years) and up to 3 years for colonoscopy depending on the year received (e.g., colonoscopy in year 1 would be assigned 3 years, colonoscopy in year 3 would be assigned 1 year). Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach.

Implementation assessment (exploratory outcome): This study will identify implementation processes and outcomes that will impact future dissemination and scalability. After the trial phase concludes, researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Trial Mailed FIT Intervention

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 do not click on the link or select a screening test receive a FIT mailed to their home address.

Group Type: EXPERIMENTAL

Mobile Health Decision Support

Intervention Type: BEHAVIORAL

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.

Trial Usual Care

Subjects 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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

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.

Interventions

Mobile Health Decision Support

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

mPATH™-Cloud

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leah M Frerichs, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Isabelle D Falk, MPH

Role: CONTACT

isabelle_falk@med.unc.edu

919-962-5498

Alexis A Moore, MPH

Role: CONTACT

919-962-5498

Facility Contacts

Alexis A Moor, MPH

Role: primary

Aliza Randazzo

Role: primary

336-716-0844

References

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.

Reference Type: DERIVED

PMID: 40781671 (View on PubMed)

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

Clinical trials at UNC Lineberger

Other Identifiers

R01CA260822

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-1969

Identifier Type: -

Identifier Source: org_study_id