Improving Fecal Immunochemical Test (FIT) Completion RatesNCT06796049
Behavioral Nudge in Colorectal Cancer Screening
A study testing Information pamphlet + social norm driver and Information pamphlet in people with Improving Fecal Immunochemical Test (FIT) Completion Rates, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Improving Fecal Immunochemical Test (FIT) Completion Rates
- What is being tested?
- Information pamphlet + social norm driver and Information pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Behavioral Nudge as a Tool to Increase CRC Screening at an Urban Center Outpatient Clinic
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.
- Being tested
- Information pamphlet + social norm driver, Information pamphlet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information pamphlet + social norm driverBehavioural
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.
Information pamphletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Information pamphlet + social norm driver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startMay 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Study was discontinued due to a lack of feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Fecal Immunochemical Test (FIT) Completion RatesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aasma Shaukat, MD, Study director, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796049
- Sponsor's protocol ID
- 24-00165
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Behavioral Nudge as a Tool to Increase CRC Screening at an Urban Center Outpatient Clinic
- ClinicalTrials.gov ID
- NCT06796049
- Acronym / sponsor ID
- 24-00165
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was discontinued due to a lack of feasibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Information pamphletA 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. |
| Time Period 3 | Experimental | Behavioral: Information pamphlet + social norm driverA 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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information pamphlet + social norm driverThe 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. | Behavioural | Time Period 3 |
| Information pamphletThe 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. | Behavioural | Time Period 2 |
Primary outcome
Time until the fecal immunochemical test (FIT) is returned to the clinic for processing
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aasma Shaukat, MD study director
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information pamphlet + social norm driver and Information pamphlet in people with Improving Fecal Immunochemical Test (FIT) Completion Rates, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until the fecal immunochemical test (FIT) is returned to the clinic for processing (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 5 Nov 2026.