Active — Not RecruitingNot Applicable

mPATH-Cloud for Colorectal Cancer Screening

United States1,062 participantsStarted 2025-06-24

Plain-language 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.

Who can participate

Age range

45 Years – 73 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation: * 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, colo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Colorectal cancer screening completion rate

Timeframe: Up to 6 months

Trial details

NCT IDNCT06441487

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

View on ClinicalTrials.gov More Colorectal Cancer trials