Clinical trial NCT06184594: Evaluating the Efficacy of the ENav Toolkit to Improve Colorectal Cancer Screening
Official title: Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Colorectal Cancer
Screening
Federally Qualified Health Centers
Digital Patient Navigation Toolkit
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The Institute for Family Health
name: National Cancer Institute (NCI)
First posted: 2023-12-28
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colorectal Cancer (CRC) Screening completion
timeFrame: End of study, at 6 months
Secondary outcomes:
measure: Number of participants who complete screening tests with adequate quality
timeFrame: End of study, at 6 months
measure: Number of participants who complete the screening test with inadequate preparation
timeFrame: End of study, at 6 months
measure: Adherence to follow up recommendations
timeFrame: End of study, at 6 months
measure: The Colorectal Cancer Screening Beliefs Instrument Score
timeFrame: Approximately 3-4 weeks after primary care appointment
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sarah Miller, PsyD
role: PRINCIPAL_INVESTIGATOR
References: