Colorectal Cancer ScreeningNCT06184594
Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening
A study testing eNav in people with Colorectal Cancer Screening, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- eNav
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 30 Apr 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient treated at the Institute for Family Health (IFH)
- Patient 45 to 75 years old
- English or Spanish speaking
- Able to provide consent within the study time frame (within a month of the primary care appointment
- Patients have access to a computer, tablet or mobile device to access the eNav Toolkit OR willing to use a clinic provided device, in person at either IFH OR Mount Sinai
- Patient scheduled for a primary care appointment at IFH
- Patients are due for colorectal cancer screening (as determined by the health maintenance alert in the medical chart)
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 100029
About this study
Official title: Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers
The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
Read the detailed description
This is a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit. A total of 400 participants will be from four FQHC clinics within the Institute for Family Health FQHC network. Participants will be randomly assigned to one of two groups:
- eNav group (N=200) or
- usual care group (N=200)
Participants will consent and complete a baseline questionnaire (demographics, medical information) 1-4 weeks before their primary care appointment.
Those in the intervention group will receive a link to the eNav website. The digital navigation tool includes a website and text-messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
The control group will receive standard clinical care.
Then 3-6 weeks after that primary care appointment, the research team will reach out to participants to complete a follow-up questionnaire. The follow up questionnaire will assess constructs guided by the health belief model (e.g., self-efficacy, benefits/barriers for CRC screening).
The impact of the eNav Toolkit on CRC screening completion at 6 months will be evaluated by checking their medical records. If a patient does not have a CRC screening recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.
- Conditions
- Colorectal Cancer Screening
- Being tested
- eNav, Standard of Care
- Keywords
- Colorectal Cancer, Screening, Federally Qualified Health Centers, Digital Patient Navigation Toolkit
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eNavOther
The eNav toolkit is a digital navigation toolkit that includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
Standard of CareOther
Standard of care procedures for selecting their CRC screening test.
| Study group | Role | What they receive |
|---|---|---|
| eNav intervention | Experimental | Subjects assigned to this arm will receive a link to the eNav website. Receives: Other: eNav |
| Usual Care Group | Placebo comparator | Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer (CRC) Screening completion
CRC, Yes/No
Medical chart review will determine whether the CRC screening was complete. If a patient does not have a CRC screening result recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.
Measured: End of study, at 6 months
Secondary outcomes (4)
Number of participants who complete screening tests with adequate quality
The number of participants who complete the screening test (i.e., colonoscopy, FIT or FIT-DNA) with adequate quality. Test quality will be coded as "inadequate" if the test needs to be repeated or cannot be resulted due to inadequate quality (e.g., poor bowel prep, inadequate stool sample).
Measured: End of study, at 6 months
Number of participants who complete the screening test with inadequate preparation
The number of participants who complete the screening test and the preparation is inadequate (e.g., poor bowel prep quality, inadequate stool sample collection).
Measured: End of study, at 6 months
Adherence to follow up recommendations
Record if the study participant is following the colorectal cancer screening recommendations after the CRC test has been completed. Measured as:
Yes = participant completed the recommended follow up No = participant did NOT complete the recommended follow up In process = the recommended follow up does not fall within the 6-month time frame Missing = data not available in the medical chart
Measured: End of study, at 6 months
The Colorectal Cancer Screening Beliefs Instrument Score
The assessments specifically measure the following Health Belief Model scales:
- Perceived Benefits of Stool-based Tests: min 3 - max 15
- Perceived Benefits of Colonoscopy: min 3 - max 15
- Perceived Susceptibility: min 2 - max 10
- Perceived Barriers of Stool-Based Tests: min 7 - max 35
- Perceived Barriers of Colonoscopy: min 9 - max 45
- Perceived Self-Efficacy of Stool-based Tests: min 8 - max 40
- Perceived Self-Efficacy of Colonoscopy: min 12 - max 60
- Perceive Severity: min 3 - max 15
Higher scores indicate greater benefit/barriers levels of the scale (e.g., higher scores = more barriers, more benefits, higher perceived susceptibility of CRC, higher levels of self-efficacy), there is no summed score.
Measured: Approximately 3-4 weeks after primary care appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start24 Jan 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute for Family Health, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sarah Miller, Icahn School of Medicine at Mount Sinai
- Investigators
- Sarah Miller, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184594
- Sponsor's protocol ID
- STUDY-20-01888
- Other IDs
- R01CA248981
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).