Mobile Health Support for Colorectal Cancer Screening

(mPATH-Cloud Trial)

Recruiting at 1 trial location

Overseen By Isabelle D Falk, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Age, CRC history, Inflammatory bowel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on colorectal cancer screening methods, so it's best to check with the study team for specific guidance.

What data supports the effectiveness of the treatment mPATH-Cloud for colorectal cancer screening?

Research shows that a similar digital health tool, mPATH-CRC, doubled the number of patients completing colorectal cancer screening, suggesting that mPATH-Cloud could also be effective in increasing screening rates. ^{1 2 3 4 5}

Is the mobile health support for colorectal cancer screening safe for humans?

The studies reviewed do not provide specific safety data for the mobile health support system, but they indicate that the apps were easy to use and well-received by both physicians and patients, suggesting no major safety concerns were reported. ^{1 4 5 6 7}

How does the mPATH-Cloud treatment differ from other colorectal cancer screening methods?

The mPATH-Cloud treatment is unique because it uses a mobile health app to support colorectal cancer screening, making it easier for patients to understand and complete the screening process. This digital approach has been shown to double the number of patients who complete their screenings compared to traditional methods. ^{1 5 8 9 10}

Research Team

Leah M Frerichs, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

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

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Subjects are randomized to either Usual Care or Mobile Health Decision Support. Those in the intervention arm use mPATH™-Cloud to select a CRC screening test.

6 months

Remote engagement via mPATH™-Cloud

Follow-up

Participants are monitored for CRC screening completion and adherence to USPSTF recommendations.

3 years

Annual assessment

Treatment Details

Interventions

• mPATH-Cloud

Trial Overview 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.

Participant Groups

Group I: Trial Mailed FIT Intervention Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Mailed reminders to patients significantly increased colorectal cancer screening rates from 38.1% to 44.0%, especially among older age groups, indicating that targeted communication can effectively promote screening.

While electronic reminders for physicians did not show a significant overall increase in screening rates, they appeared to be beneficial for patients with frequent primary care visits, suggesting that tailored approaches may enhance screening efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Sequist, TD., Zaslavsky, AM., Marshall, R., et al.[2022]

Patients who received a decision aid from their family physician had a higher fecal occult blood test (FOBT) completion rate (66.6%) compared to those who did not receive the aid (56.9%), indicating that physician recommendations significantly boost screening rates.

The study found that the use of the decision aid itself was low (only 1.1% of patients utilized it), suggesting that direct encouragement from physicians is a more effective strategy for increasing colorectal cancer screening, especially for patients aged 50-59.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: results from a pragmatic cluster randomized controlled trial. Clouston, K., Katz, A., Martens, PJ., et al.[2021]

A systematic review of 2,790 mobile health apps found 20 that could potentially improve colorectal cancer (CRC) screening uptake, but most were primarily informational and focused mainly on colonoscopies.

Despite the availability of these apps, there is a lack of empirical evidence on their effectiveness and usability, highlighting the need for future research to assess their content and impact on CRC screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Colorectal Cancer Screening-Related Apps. Jiang, Z., Hussain, A., Grell, J., et al.[2023]

A systematic review of ten randomized controlled trials involving adults due for colorectal cancer screening found that mobile health (mHealth) interventions significantly increased screening rates compared to usual care, with an adjusted odds ratio of 1.33.

The effectiveness of mHealth interventions was consistent across various methods, including automated phone education and text-message reminders, indicating that these digital tools can effectively promote colorectal cancer screening participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health interventions for improving colorectal cancer screening rates: A systematic review and meta-analysis. Elepaño, A., Fusingan, AS., Yasay, E., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Usefulness of a mobile app to improve performance of specialists in responding correctly to CRC screening and surveillance clinical scenarios. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: results from a pragmatic cluster randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Electronic patient messages to promote colorectal cancer screening: a randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of a Digital Health Intervention on Decreasing Barriers and Increasing Facilitators for Colorectal Cancer Screening in Vulnerable Patients. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening: physicians' knowledge of risk assessment and guidelines, practice, and description of barriers and facilitators. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Mobile App to Increase Informed Decisions About Colorectal Cancer Screening Among African American and Caucasian Women: A Pilot Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Colorectal Cancer Screening-Related Apps. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Acceptability, Utility, and Cost of a Mobile Health Cancer Screening Education Application for Training Primary Care Physicians in India. [2021]

10. Thailand pubmed.ncbi.nlm.nih.gov

Mobile health interventions for improving colorectal cancer screening rates: A systematic review and meta-analysis. [2022]