NCT06184594

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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).

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: 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

• Colorectal Cancer Screening

Interventions

Type	Name	Description
OTHER	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).
OTHER	Standard of Care	Standard of care procedures for selecting their CRC screening test.

Timeline

• Start date: 2024-01-24
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2023-12-28
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States