Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06184594

Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening

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).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Colorectal Cancer Screening Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 100029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Unable to provide informed consent

Treatment and study plan

eNav

Other

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 care

Other

Standard of care procedures for selecting their CRC screening test.

Primary outcomes

  1. Colorectal Cancer (CRC) Screening completion

    Time frame: End of study, at 6 months

    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.

Secondary outcomes

  1. Number of participants who complete screening tests with adequate quality

    Time frame: End of study, at 6 months

    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).

  2. Number of participants who complete the screening test with inadequate preparation

    Time frame: End of study, at 6 months

    The number of participants who complete the screening test and the preparation is inadequate (e.g., poor bowel prep quality, inadequate stool sample collection).

  3. Adherence to follow up recommendations

    Time frame: End of study, at 6 months

    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

  4. The Colorectal Cancer Screening Beliefs Instrument Score

    Time frame: Approximately 3-4 weeks after primary care appointment

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Cancer Institute (NCI)
  • The Institute for Family Health

Registry information

Official study title

Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 28, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.