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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile health tool, mPATH™-Cloud, can increase colorectal cancer (CRC) screening completion compared to usual care. Participants overdue for CRC screenings are divided into two groups: one receives standard screening advice, while the other uses mPATH™-Cloud to choose between a stool test or a colonoscopy. The study evaluates whether the mobile tool enhances screening completion within six months. It is suitable for individuals aged 45-73 who have not had recent CRC screenings and do not have a family history of CRC or related health conditions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future CRC screening processes.

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 prior data suggests that the mPATH-Cloud intervention is safe for colorectal cancer screening?

Research has shown that mPATH-Cloud, a mobile health tool for colorectal cancer screening, is user-friendly and well-liked by patients. While specific safety details for mPATH-Cloud are not provided in the studies, its use in other situations has not resulted in any reported safety issues, suggesting it is likely safe. The system assists individuals in choosing between a stool test or a colonoscopy for cancer screening. Its successful and safe use in other studies can reassure those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Support for Colorectal Cancer Screening trial because it explores how digital tools can improve cancer screening rates. Unlike traditional methods that rely on in-person doctor visits, the mPATH-Cloud tool offers a convenient, mobile-based approach. Participants can engage with the app to choose their preferred screening method and even have tests mailed to their homes if they don't act, which could increase screening rates by reducing barriers like scheduling and travel. This innovative approach could make colorectal cancer screening more accessible and proactive, especially for people with busy lifestyles or limited access to healthcare facilities.

What evidence suggests that the mPATH-Cloud intervention is effective for increasing colorectal cancer screening completion?

Research has shown that mPATH™-Cloud, which participants in this trial may use, can increase colorectal cancer screening rates. One study found that users of mPATH™-Cloud were more likely to complete their screening tests within 16 weeks compared to non-users. The tool assists by sending reminders and providing a video to guide users in selecting the best screening test. In past trials, this approach led to more people completing tests like FIT (a stool test for blood) and colonoscopies. These results suggest that mPATH™-Cloud effectively encourages completion of important cancer screenings. ^{1 2 6 7 8}

Who Is on the Research Team?

Leah M Frerichs, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06441487

mPATH-Cloud for Colorectal Cancer Screening This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10103028/

Effectiveness and implementation of mPATH™-CRC: a mobile ... Effectiveness of mPATH™-CRC is evaluated by comparing the proportion who complete CRC screening within 16 weeks of their visit to the clinic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06821009

Effectiveness of a Cloud-based Digital Health Navigation ... This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335168/

study protocol for a hybrid type I trial - PMC - PubMed Central In partnership with a rural federally qualified health center, this study will evaluate the impact of mPATH-CRC® on CRC screening outcomes, ...

5. smartpatients.com smartpatients.com/trials/NCT06441487

mPATH-Cloud for Colorectal Cancer Screening This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03843957

Effectiveness and Implementation of mPATH-CRC A structured online system, such as the ClinicalTrials.gov results ... Effectiveness and implementation of mPATH-CRC: a mobile health system for colorectal cancer ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7416430/

Effect of a Digital Health Intervention on Decreasing ... Conclusions: mPATH-CRC increased completion of CRC screening by affecting patient-level and system-level mediators. However, the most powerful ...

8. withpower.com withpower.com/trial/phase-colorectal-carcinoma-crc-5-2025-4ba3c

Mobile Health Support for Colorectal Cancer Screening 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 ...