Mobile Health Support for Colorectal Cancer Screening
(mPATH-Cloud Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byLeah M Frerichs, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals overdue for colorectal cancer screening as per USPSTF guidelines, served by a health center in North Carolina. Participants must be comfortable with mobile or mail communication and willing to potentially engage with an online decision aid.

Inclusion Criteria

For the second and third study rounds only: No record of a positive (abnormal) CRC screening result in a previous study round

I am between 45 and 73 years old.

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 CT colonography within 10 years of the EHR query date

+3 more

Exclusion Criteria

For second and third annual study rounds only: Record of a positive (abnormal) CRC screening result in a previous study round

I am either under 45 or over 73 years old.

Not an active client of the clinic as documented in the EHR (not seen at least 2 times within the past 12 months)

+3 more

Participant Groups

The study compares usual care (in-person recommendations and referrals) against a mobile health intervention where participants receive messages to use mPATH™-Cloud, helping them choose between FIT tests or colonoscopies for colorectal cancer screening.

2Treatment groups

Experimental Treatment

Active Control

Group I: Trial Mailed FIT InterventionExperimental Treatment1 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 II: Trial Usual CareActive Control1 Intervention

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.