Digital Health Program for Colorectal Cancer Screening

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

Trial Summary

What is the purpose of this trial?

mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. 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 care setting; and (2) determine the value generated by mPATH in each healthcare setting.

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

Research shows that the mPATH-CRC program, an iPad-based application, doubled the number of patients completing colorectal cancer screening. Additionally, digital decision-making aids like mPATH-CRC have been found to significantly improve screening rates compared to usual care. ^{1 2 3 4 5}

Is the mPATH-CRC digital health program safe for humans?

The available research does not specifically mention any safety concerns related to the mPATH-CRC program, which is a digital tool designed to help increase colorectal cancer screening rates. ^{1 2 5 6 7}

How is the mPATH-CRC treatment different from other colorectal cancer screening methods?

The mPATH-CRC treatment is unique because it uses an iPad-based application to help patients understand and choose the best colorectal cancer screening option for them, aiming to increase screening rates. Unlike traditional methods, it provides personalized education and decision support, making it easier for patients to overcome barriers to screening. ^{1 2 5 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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

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

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

Improving Fecal Immunochemical Test Return Rates: A Colorectal Cancer Screening Quality Improvement Project in a Multisite Federally Qualified Health Center. [2023]

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

How effective are digital technology-based interventions at promoting colorectal cancer screening uptake in average-risk populations? A systematic review and meta-analysis of randomized controlled trials. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness and implementation of mPATH™-CRC: a mobile health system for colorectal cancer screening. [2023]

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

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

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

Preference-based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial. [2022]

8. Ireland 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. [2018]

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

Selection of patients for large mailed fecal immunochemical test colorectal cancer screening outreach programs: A systematic review. [2021]