NCT07361614

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

January 21, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

CRCColorectal

Outcome Measures

Primary Outcomes (1)

  • CRC screening completion (yes/no)

    Month 6

Secondary Outcomes (4)

  • Change in Brief Illness Perception Questionnaire (IPQ-B) score

    Baseline, Month 6

  • Change in Medicines Questionnaire (BMQ) score

    Baseline, Month 6

  • Change in number of barriers to care

    Baseline, Month 6

  • Change in trust in health/community health workers

    Baseline, Month 6

Study Arms (1)

Adults due for CRC screening who speak English or a Chinese language (Cantonese/Mandarin)

EXPERIMENTAL

Participants will receive one CRC educational session, which will take around 1-1.5 hours.

Behavioral: Educational Program

Interventions

Culturally and linguistically tailored program consisting of community health worker (CHW)-led education sessions followed by patient navigation (PN) services.

Adults due for CRC screening who speak English or a Chinese language (Cantonese/Mandarin)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • \) history of CRC or colectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

  • Suzanne Vang

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 23, 2026

Study Start

February 5, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations