Colorectal Cancer ScreeningNCT06241768
Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients
A study testing mPATH-CRC Web app in people with Colorectal Cancer Screening, run by Digital Health Navigation Solutions, Inc at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are: Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program?… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- mPATH-CRC Web app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 921 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 26 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a phone number listed in the electronic health record
- Language preference of English in the electronic health record
- Have a scheduled primary care appointment within the next 15 days
Who cannot join
- Prior diagnosis of colorectal cancer
- Prior diagnosis of inflammatory bowel disease
- Have a record in the electronic health record of completing a colonoscopy within the last 10 years, a FIT-DNA test within the last 3 years, or a fecal immunochemical test (FIT) within the last 1 year
- Have an electronic Charlson Comorbidity Index > 2
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are:
- Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program?
- How many patients will respond to a text message intervention to use the web app?
Read more
Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program.
Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.
- Conditions
- Colorectal Cancer Screening
- Being tested
- mPATH-CRC Web app
- Keywords
- colorectal cancer screening, pragmatic clinical trial, randomized clinical trial, digital health, feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPATH-CRC Web appOther
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
| Study group | Role | What they receive |
|---|---|---|
| Text message 1 | Experimental | Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program Receives: Other: mPATH-CRC Web app |
| Text message 2 | Experimental | Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program Receives: Other: mPATH-CRC Web app |
| Text message 3 | Experimental | Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program Receives: Other: mPATH-CRC Web app |
| Text message 4 | Experimental | Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program Receives: Other: mPATH-CRC Web app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test
Number (and proportion) of participants who are confirmed eligible for CRC screening and request a CRC screening test within the mPATH-CRC Web App
Measured: 28 days
Secondary outcomes (1)
Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App
Number (and proportion) of participants who complete the CRC screening eligibility questions within 4 weeks of the initial invitation using the mPATH-CRC Web App
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Feb 2024
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Digital Health Navigation Solutions, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Miller, MD, MS, Principal investigator, Digital Health Navigation Solutions, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241768
- Sponsor's protocol ID
- 93476
- Other IDs
- R42CA275665
- Status last verified
- Jun 2025
- First submitted
- 28 Jan 2024
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share the data dictionary and de-identified individual participant data that underlie our published results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT06241768
- Acronym / sponsor ID
- 93476
- Conditions
- Colorectal Cancer Screening
- Keywords
- colorectal cancer screening, pragmatic clinical trial, randomized clinical trial, digital health, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Digital Health Navigation Solutions, IncIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences, National Cancer Institute (NCI)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are:
- Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program?
- How many patients will respond to a text message intervention to use the web app?
Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program.
Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Text message 1 | Experimental | Other: mPATH-CRC Web appVersion 1 of the text message invitation to use the cloud-based colorectal cancer screening program |
| Text message 2 | Experimental | Other: mPATH-CRC Web appVersion 2 of the text message invitation to use the cloud-based colorectal cancer screening program |
| Text message 3 | Experimental | Other: mPATH-CRC Web appVersion 3 of the text message invitation to use the cloud-based colorectal cancer screening program |
| Text message 4 | Experimental | Other: mPATH-CRC Web appVersion 4 of the text message invitation to use the cloud-based colorectal cancer screening program |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a phone number listed in the electronic health record
- Language preference of English in the electronic health record
- Have a scheduled primary care appointment within the next 15 days
Key exclusion criteria (4 listed)
- Prior diagnosis of colorectal cancer
- Prior diagnosis of inflammatory bowel disease
- Have a record in the electronic health record of completing a colonoscopy within the last 10 years, a FIT-DNA test within the last 3 years, or a fecal immunochemical test (FIT) within the last 1 year
- Have an electronic Charlson Comorbidity Index > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mPATH-CRC Web appCloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening | Other | Text message 1, Text message 2, Text message 3, Text message 4 |
Primary outcome
Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test
Time frame: 28 days
Number (and proportion) of participants who are confirmed eligible for CRC screening and request a CRC screening test within the mPATH-CRC Web App
1 secondary outcome
Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators will share the data dictionary and de-identified individual participant data that underlie our published results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Miller, MD, MS principal investigator
Digital Health Navigation Solutions, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPATH-CRC Web app in people with Colorectal Cancer Screening, run by Digital Health Navigation Solutions, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.