- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06796049
Behavioral Nudge in Colorectal Cancer Screening
Role of Behavioral Nudge as a Tool to Increase CRC Screening at an Urban Center Outpatient Clinic
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
-
New York, New York, United States, 10016
- NYU Langone Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Time Period 1 Inclusion Criteria:
- Patient at Bellevue Ambulatory Care Medicine Clinic between 1/1/2024 and 7/1/2024
- Age 45-75 years old
Time Period 2 Inclusion Criteria:
- Patient at Bellevue Ambulatory Care Resident Clinic
- Age 45-75 years old
- Has not had a FIT test within the past year
- Can read either English or Spanish
- Is able and willing to provide consent
Time Period 3 Inclusion Criteria:
- Patient at Bellevue Ambulatory Care Resident Clinic
- Age 45-75 years old
- Has not had a FIT test completed within the past year
- Can read either English or Spanish
- Is able and willing to provide consent
Time Period 1 Exclusion Criteria:
- Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
- Age outside of 45-75 years old
Time Period 2 Exclusion Criteria:
- Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
- Age outside of 45-75 years old
- Has had a FIT test completed within the past year
- Cannot read either English or Spanish
Time Period 3 Exclusion Criteria:
- Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
- Age outside of 45-75 years old
- Has had a FIT test completed within the past year
- Cannot read either English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Time Period 1
A FIT test is ordered by the provider and a patient care assistant (PCA) gives patient a FIT kit, which includes a specimen cup and instructions on how to use it, at the end of the visit prior to their departure.
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|
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Experimental: Time Period 2
A new information pamphlet is given to participants alongside the FIT kit at the end of the visit.
The pamphlet contains an easy-to-read description of FIT screening adapted from the NYC department of health C5 Colorectal cancer (CRC) screening coalition pamphlet and lead-time CRC screening messaging tool, instructions on how to complete the test and the importance of FIT screening.
|
The information pamphlet is given to participants at the end of the visit.
The pamphlet contains an easy-to-read description of FIT screening adapted from the NYC department of health C5 CRC screening coalition pamphlet and lead-time CRC screening messaging tool, instructions on how to complete the test and the importance of FIT screening.
|
|
Experimental: Time Period 3
A new information pamphlet is given to participants along the FIT kit similar to "Time period 2", but includes a social norm driver in the pamphlet that displays the sub-par screening rate of our clinic compared to a collective New York State screening rate and a national screening rate goal set by the Centers for Disease Control and Prevention (CDC).
|
The information pamphlet is given to participants at the end of the visit. The pamphlet contains an easy-to-read description of FIT screening adapted from the NYC department of health C5 Colorectal cancer (CRC) screening coalition pamphlet and lead-time CRC screening messaging tool, instructions on how to complete the test and the importance of FIT screening. The information pamphlet will also contain a social norm driver that displays the sub-par screening rate the clinic compared to a collective New York State screening rate and a national screening rate goal set by the CDC. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time until the fecal immunochemical test (FIT) is returned to the clinic for processing
Time Frame: Month 3
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Study participants will be tracked for completion of their FIT screening test up until 3 months after the initial stool study was given.
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Month 3
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Percentage of participants who completed the FIT screening test
Time Frame: Month 3
|
Study participants will be tracked for completion of their FIT screening test up until 3 months after the initial stool study was given.
|
Month 3
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aasma Shaukat, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24-00165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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