NCT06796049

Brief Summary

The purpose of this study is to evaluate if a behavioral nudge principle known as social norm driver can be implemented to improve fecal immunochemical test (FIT) completion rates for patients' age 45-75 years old due for colorectal cancer screening at Bellevue Hospital Medicine Ambulatory Care Clinic. The study's endpoints include FIT screening completion rate and timeliness. Secondary analysis will look at demographic information such as age group, gender, prior screening, number of prior visits at the clinic.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
0mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
May 2025Jul 2026

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 22, 2025

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time until the fecal immunochemical test (FIT) is returned to the clinic for processing

    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

  • Percentage of participants who completed the FIT screening test

    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

Study Arms (3)

Time Period 1

NO INTERVENTION

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.

Time Period 2

EXPERIMENTAL

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.

Behavioral: Information pamphlet

Time Period 3

EXPERIMENTAL

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).

Behavioral: Information pamphlet + social norm driver

Interventions

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.

Time Period 3

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.

Time Period 2

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at Bellevue Ambulatory Care Medicine Clinic between 1/1/2024 and 7/1/2024
  • Age 45-75 years old
  • 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
  • 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

You may not qualify if:

  • Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
  • Age outside of 45-75 years old
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Aasma Shaukat, MD

    NYU Langone Health

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

May 1, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be available to other researchers. Access to this aggregated study database will be limited to HIPAA certified investigators who have been IRB-approved for participation in this study.

Locations