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

NCT06184594 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY-20-01888R01CA248981
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Colorectal Cancer Screening

Keywords

Colorectal Cancer; Screening; Federally Qualified Health Centers; Digital Patient Navigation Toolkit

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study, at 6 months

Secondary Outcomes (4)

• Number of participants who complete screening tests with adequate quality

  End of study, at 6 months

• Number of participants who complete the screening test with inadequate preparation

  End of study, at 6 months

• Adherence to follow up recommendations

  End of study, at 6 months

• The Colorectal Cancer Screening Beliefs Instrument Score

  Approximately 3-4 weeks after primary care appointment

Study Arms (2)

eNav intervention

EXPERIMENTAL

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

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.

Other: Standard of Care

Interventions

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).

eNav intervention

Standard of Care OTHER

Standard of care procedures for selecting their CRC screening test.

Usual Care Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The Institute for Family Health: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 100029, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah Miller, PsyD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

Locations

US (1)