Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eNav, Standard of Care.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Screening. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers
Overview
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.
Interventions
- 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.
Primary outcome measures
- Colorectal Cancer (CRC) Screening completion [Time frame: End of study, at 6 months]
Secondary outcome measures (4)
- Number of participants who complete screening tests with adequate quality [Time frame: End of study, at 6 months]
- Number of participants who complete the screening test with inadequate preparation [Time frame: End of study, at 6 months]
- Adherence to follow up recommendations [Time frame: End of study, at 6 months]
- The Colorectal Cancer Screening Beliefs Instrument Score [Time frame: Approximately 3-4 weeks after primary care appointment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT06184594 · STUDY-20-01888 · R01CA248981