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

NCT ID: NCT06184594

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2026-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. eNav group (N=200) or
2. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

eNav intervention

Subjects assigned to this arm will receive a link to the eNav website.

Group Type EXPERIMENTAL

eNav

Intervention Type 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).

Usual Care Group

Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care.

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard of care procedures for selecting their CRC screening test.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eNav

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).

Intervention Type OTHER

Standard of Care

Standard of care procedures for selecting their CRC screening test.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Institute for Family Health

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sarah Miller

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah Miller, PsyD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA248981

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-20-01888

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Patient Navigation for Colorectal Cancer Screening
NCT06401174 ENROLLING_BY_INVITATION NA