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

Colorectal Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06184594
• Other study ID #: STUDY-20-01888
• Secondary ID: R01CA248981
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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 3-4 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

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).
• Standard of Care
Standard of care procedures for selecting their CRC screening test.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Cancer Institute (NCI), The Institute for Family Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	End of study, at 6 months
Secondary	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).	End of study, at 6 months
Secondary	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	End of study, at 6 months
Secondary	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.	Approximately 3-4 weeks after primary care appointment