Digital Health Program for Colorectal Cancer Screening

Recruiting at 1 trial location

Overseen By David Miller, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Digital Health Navigation Solutions, Inc

Disqualifiers: Colorectal cancer, Inflammatory bowel, others

Compensation: Varies

Number of Visits: Unknown

6500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital program called mPATH-CRC, designed to help people screen for colorectal cancer from home. Participants use an app on their devices to learn about screening options and request tests. The trial aims to evaluate the program's effectiveness in various healthcare settings. It suits individuals aged 45-74 who haven't had recent colorectal cancer screenings and have a phone number on file. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could simplify cancer screening for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital health program is safe for colorectal cancer screening?

Research has shown that mPATH-CRC, a digital health program for colorectal cancer screening, has been used in earlier studies without safety concerns. The program educates users about their screening options and allows them to request tests if needed. As a digital tool rather than a drug or medical procedure, mPATH-CRC poses minimal risk of physical harm. Participants use the program on their own devices, further reducing potential safety issues. Previous studies have examined its effectiveness and usability, suggesting that users generally have a positive experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mPATH-CRC program because it introduces a digital twist to colorectal cancer screening. Unlike traditional methods that rely on in-person consultations and procedural reminders, mPATH-CRC uses a WebApp accessible via a simple text message invitation. This app not only verifies when you're due for a screening but also educates you about your options and allows you to request a screening test from the comfort of your home. This convenient and streamlined approach aims to increase screening rates by making the process more accessible and user-friendly.

What evidence suggests that the mPATH-CRC program is effective for colorectal cancer screening?

In this trial, participants assigned to the mPATH-CRC arm will receive a text message inviting them to use the mPATH-CRC WebApp. Studies have shown that mPATH-CRC effectively increases colorectal cancer screening rates. Earlier research found the tablet version of mPATH-CRC easy for patients to use and successful in encouraging them to complete their screenings. The program educates users about screening options and allows them to request a test directly, simplifying and enhancing accessibility. However, another study found that once tests were ordered, completion rates were similar whether participants used mPATH or standard care. This suggests that while mPATH-CRC helps initiate the process and order tests, completion rates may not differ significantly from usual care. Overall, mPATH-CRC aims to simplify the screening process and encourage more people to get tested. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible for colorectal cancer screening. Participants will use their own devices to access a cloud-based digital health program, mPATH-CRC, aimed at facilitating the screening process. The specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I haven't had recent colorectal cancer screenings as recommended.

I am between 45 and 74 years old.

My cell phone number is listed in my electronic health record.

Exclusion Criteria

I have been diagnosed with colorectal cancer before.

I do not have severe liver disease, metastatic cancer, or AIDS.

I have been diagnosed with inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Health Navigation

Participants use the mPATH-CRC WebApp to verify if they are due for CRC screening, learn about options, and request a screening test

4 weeks

Remote access via personal devices

Follow-up

Participants are monitored for completion of CRC screening tests and outcomes

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mPATH-CRC

Trial Overview The study is testing the effectiveness of mPATH-CRC, a digital health navigation program designed to help patients arrange colorectal cancer screenings from home. It compares this new method with usual care practices in two healthcare settings: Fee-for-Service and value-based care.

How Is the Trial Designed?

Group I: mPATH-CRC Experimental Treatment 1 Intervention

Participants randomized to the mPATH arm will receive a text message inviting them to use the mPATH-CRC WebApp. The WebApp verifies individuals are due for routine colorectal cancer (CRC) screening, educates them about their options, and lets them request a screening test via the program.

Group II: Usual Care (Control) Placebo Group 1 Intervention

Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening.

Who Is Running the Clinical Trial?

Digital Health Navigation Solutions, Inc

Lead Sponsor

Trials

2

Recruited

7,500+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A personally tailored interactive multimedia computer program (IMCP) significantly improved self-efficacy for colorectal cancer (CRC) screening and increased readiness for screening among 49 participants in a pilot trial.

Compared to a non-tailored control, the tailored IMCP showed promise in reducing perceived barriers to screening, suggesting that personalized approaches could enhance CRC screening uptake in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a tailored interactive multimedia computer program on determinants of colorectal cancer screening: a randomized controlled pilot study in physician offices. Jerant, A., Kravitz, RL., Rooney, M., et al.[2018]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03843957

Effectiveness and Implementation of mPATH-CRC The study team has developed mPATH-CRC (mobile PAtient Technology for Health-Colorectal Cancer), a patient-friendly iPad program used by individuals ...

3. aacrjournals.org aacrjournals.org/cebp/article/29/8/1564/72434/Effect-of-a-Digital-Health-Intervention-on

Effect of a Digital Health Intervention on Decreasing Barriers ... Overall, patients in both the mPATH and Control arms were equally likely to complete colorectal cancer tests once they were ordered (43% and 46% respectively, P ...

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-025-13262-y

Using a digital health platform to implement a multi ... In partnership with a rural federally qualified health center, this study will evaluate the impact of mPATH-CRC® on CRC screening outcomes, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06821009

Effectiveness of a Cloud-based Digital Health Navigation ... mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this ...

6. 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), ...

7. school.wakehealth.edu school.wakehealth.edu/features/research/mpath

On the mPATH to Better Health and Longer Lives The platform currently consists of mPATH-CRC, which is designed to increase screening for colorectal cancer (CRC), the second-leading cause of cancer deaths in ...