Pilot Testing of a Colorectal Cancer Education Program

April 23, 2026 updated by: NYU Langone Health
The primary objective of this study is to assess the feasibility, acceptability, and preliminary efficacy of a culturally and linguistically targeted, colorectal cancer (CRC) education program to improve CRC screening completion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 45-75 years
  2. Not guideline concordant (no stool testing for CRC within past 1 year)
  3. No colonoscopy in past 10 years; no sigmoidoscopy or CT colonography in past 5 years)
  4. Understands English or Chinese languages.
  5. Willing and able to consent to participate

Exclusion Criteria:

1) history of CRC or colectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults due for CRC screening who speak English or a Chinese language (Cantonese/Mandarin)
Participants will receive one CRC educational session, which will take around 1-1.5 hours.
Behavioral: Educational Program
Culturally and linguistically tailored program consisting of community health worker (CHW)-led education sessions followed by patient navigation (PN) services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CRC screening completion (yes/no)
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Illness Perception Questionnaire (IPQ-B) score
Time Frame: Baseline, Month 6
The IPQ-B is a 9-item questionnaire (validated in the Chinese population) that assesses CRC beliefs according to CRC beliefs according to SRM constructs (SRM) constructs. Each item is rated on a scale from 0 (strong disagree) to 10 (strongly agree). Total scores range from 0-90, with higher scores indicating a greater threat and worse perception of illness.
Baseline, Month 6
Change in Medicines Questionnaire (BMQ) score
Time Frame: Baseline, Month 6
The BMQ, validated in the Chinese population, adapted to assess concerns/necessity of CRC screening is a 5 items questionnaire. Items are assessed on a scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 5-25, with higher scores indicating positive beliefs about CRC screening.
Baseline, Month 6
Change in number of barriers to care
Time Frame: Baseline, Month 6
Participants re asked to select all that apply to barriers in care: Cost, Transportation, Lack of time, Fear of results, Embarrassment, Lack of trust in doctors, Language barriers, Other. Each item selected is counted, a decrease in the number of items selected indicates reduced barriers to care.
Baseline, Month 6
Change in trust in health/community health workers
Time Frame: Baseline, Month 6
Group-based medical mistrust scale consists of 2 statements of mistrust and 2 statements of trust. Each statement can be answered with 1) Strongly Disagree, 2) Disagree, 3) Neither Agree nor Disagree, 4) Agree, 5) Strongly Agree.
Baseline, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Suzanne Vang, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-01040
  • K01CA255411 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to Suzanne.vang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Suzanne.vang@nyulangone.org To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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