Colorectal Cancer ScreeningNCT06821009
Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
A study testing mPATH-CRC in people with Colorectal Cancer Screening, run by Digital Health Navigation Solutions, Inc at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- mPATH-CRC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-74 years
- Be identified in the electronic health record as due for routine CRC screening, defined as
- No colonoscopy in prior 10 years
- No flexible sigmoidoscopy in prior 5 years
- No CT colography in prior 5 years
- No FIT-DNA test (Cologuard) within prior 3 years
Show all 11Show fewer
- No Fecal Occult Blood Test within prior 1 year
- Have a cell phone number listed in the EHR
- Have a preferred language of English or Spanish in the EHR
- Upcoming appointment within 9 to 16 days
- Georgia Market Only: Insurance type is listed as Medicare Advantage.
Who cannot join
- Prior diagnosis of colorectal cancer
- Prior history of total colectomy
- Currently enrolled in palliative care or Hospice
- Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
- Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atrium Health Floyd
Rome, Georgia, 30161
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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.
- Conditions
- Colorectal Cancer Screening
- Being tested
- mPATH-CRC, Usual Care (Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPATH-CRCOther
Individuals will receive an automated text message inviting them to use the mPATH-CRC WebApp. The WebApp takes approximately 5 to 8 minutes to complete. The WebApp verifies patients are due for routine CRC screening, educates them about their options, and lets them request a screening test via the program.
Usual Care (Control)Other
Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening. In the participating Fee-for-Service and Value-Based settings, the EHR flags patients who are overdue for CRC screening as a "care gap" that is visible to all primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| mPATH-CRC | Experimental | 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. Receives: Other: mPATH-CRC |
| Usual Care (Control) | Placebo comparator | Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening. Receives: Other: Usual Care (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of mPATH-CRC
The proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms
Measured: 180 Days
Secondary outcomes (6)
Reach of mPATH-CRC
The proportion of patients in the mPATH-CRC arm who complete the mPATH-CRC Web App to the point of being told if screening is due or not due
Measured: 30 Days
Reporting current CRC screening
The proportion of participants within the mPATH arm who report they are current with CRC screening within the mPATH program.
Measured: 30 Days
CRC screening ordered
The proportion of patients who have a CRC screening test ordered within 180 days of randomization in both arms.
Measured: 180 Days
Colorectal Neoplasia
The proportion of patients in each arm with neoplasia found on colonoscopy within 180 days after randomization.
Measured: 180 days
Mean revenue generated in a Fee-for-Service setting
Mean revenue generated in a Fee-for-Service setting from screening and resulting downstream care within 12 months (365 days) of the screening event, assuming Medicare reimbursement rates in both arms.
Measured: 365 Days
Quality gaps closed in a value-based care setting
Proportion of quality gaps closed in a value-based setting in each arm defined as completing screening or acquiring documentation of previously completed screening in both arms.
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start9 Jun 2025
- Primary completion14 Aug 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digital Health Navigation Solutions, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Wake Forest University Health Sciences
- Responsible party
- Principal investigator, David P. Miller, Jr., Digital Health Navigation Solutions, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821009
- Sponsor's protocol ID
- IRB00118236
- Other IDs
- 4R42CA275665
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual participant data that underlie our published or presented results.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT06821009
- Acronym / sponsor ID
- IRB00118236
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Digital Health Navigation Solutions, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Wake Forest University Health Sciences
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mPATH-CRC | Experimental | Other: mPATH-CRCParticipants 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. |
| Usual Care (Control) | Placebo comparator | Other: Usual Care (Control)Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 45-74 years
- Be identified in the electronic health record as due for routine CRC screening, defined as
- Have a cell phone number listed in the EHR
- Have a preferred language of English or Spanish in the EHR
- Upcoming appointment within 9 to 16 days
Key exclusion criteria (5 listed)
- Prior diagnosis of colorectal cancer
- Prior history of total colectomy
- Currently enrolled in palliative care or Hospice
- Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
- Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)
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-CRCIndividuals will receive an automated text message inviting them to use the mPATH-CRC WebApp. The WebApp takes approximately 5 to 8 minutes to complete. The WebApp verifies patients are due for routine CRC screening, educates them about their options, and lets them request a screening test via the program. | Other | mPATH-CRC |
| Usual Care (Control)Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening. In the participating Fee-for-Service and Value-Based settings, the EHR flags patients who are overdue for CRC screening as a "care gap" that is visible to all primary care providers. | Other | Usual Care (Control) |
Primary outcome
Effectiveness of mPATH-CRC
Time frame: 180 Days
The proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms
6 secondary outcomes
Reach of mPATH-CRC
Time frame: 30 Days
Reporting current CRC screening
Time frame: 30 Days
CRC screening ordered
Time frame: 180 Days
Colorectal Neoplasia
Time frame: 180 days
Mean revenue generated in a Fee-for-Service setting
Time frame: 365 Days
Quality gaps closed in a value-based care setting
Time frame: 180 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. We will share de-identified individual participant data that underlie our published or presented results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPATH-CRC in people with Colorectal Cancer Screening, run by Digital Health Navigation Solutions, Inc at 2 sites 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 11 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Effectiveness of mPATH-CRC (time frame: 180 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 9 Oct 2026.