NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation (NYC CONNECT)

NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation Randomized Controlled Trial (NYC CONNECT)

NYC CONNECT will carry out a randomized controlled trial (RCT) which will assess the relative effectiveness of two evidence-based strategies to increase cancer screening rates for breast, cervical, and colorectal cancer. The RCT will compare the effectiveness of using a combination of 1) culturally and linguistically tailored cancer education materials and 2) community health workers (CHWs) to provide navigation services for cancer screening (the "patient navigation" [PN] arm) versus providing culturally and linguistically tailored cancer education only (the "less intensive" [LI] arm). The study population will include individuals who are due for breast, cervical, or colorectal cancer screening. All individuals recruited to the study will be provided navigation for unmet social determinants of health (SDH) needs.

Study Overview

• Status: Recruiting
• Conditions: Cancer Screening
• Intervention / Treatment: Behavioral: Patient Navigation (PN) - More Intensive; Behavioral: Educational Materials; Behavioral: Patient Navigation (PN) - Less Intensive

• Study Type: Interventional
• Enrollment (Estimated): 2160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chau Trinh-Shevrin, DrPH; Phone Number: 646-501-3480; Email: chau.trinh@nyulangone.org
• Study Contact Backup: Name: Perla Chebli, PhD; Phone Number: 646-501-3524; Email: perla.chebli@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Albert Einstein College Of Medicine
      • Contact: Bruce Rapkin; Phone Number: 718-839-7453; Email: bruce.rapkin@einsteinmed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women between the ages of 21 and 75 years;
• Men between the ages of 45 and 75 years;
• Women (40-74 years) who have not had a mammogram in the past 12 months, a Pap smear in the last 3 years (21-64 years old) or HPV test in the last 5 years (30-64 years old), or women 45-75 years old who are not up-to-date on colorectal cancer screening (Fecal occult blood test (FOBT)/Fecal immunochemical test (FIT) past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
• Men not up-to-date on colorectal cancer screening (FOBT/FIT past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
• Must speak either English, Spanish, Haitian-Creole, French, or Chinese (Mandarin and Cantonese);
• Lives in East Flatbush (zip codes: 11236, 11203, 11212, 11226); Sunset Park (zip codes: 11215, 11220, 11232); Highbridge (zip code 10452, 10455, 10451); or Morrisania (zip codes: 10456, 10459)

Exclusion Criteria:

• Previous or current diagnosis of any cancer;
• Pregnancy (breast and cervical cancer only);
• Current participation in an existing cancer navigation program;
• Currently in hospice care;
• At least 66 years of age with advanced illness or frailty or who live in long-term institution for more than 90 days;
• Bilateral mastectomy or right and left unilateral mastectomy (breast cancer only);
• Hysterectomy with no residual cervix (cervical cancer only);
• Total colectomy (colorectal cancer only).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Navigation (PN); Participants randomized to the PN arm will receive community health worker (CHW)-administered PN for cancer screening + social service needs + culturally and linguistically tailored cancer education. All individuals will complete a survey at baseline, 3 months, and 6 months.	Behavioral: Patient Navigation (PN) - More Intensive; The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for cancer screening status and social needs and provide navigational support to cancer screening and social services.; Behavioral: Educational Materials; Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
Active Comparator: Less Intensive (LI); Participants randomized to LI arm will receive PN to social service needs + culturally and linguistically tailored cancer education materials. All individuals will complete a survey at baseline, 3 months, and 6 months. Once a participant randomized to the LI arm completes the 6-month survey, they will have the option to receive all navigational support provided by CHWs to individuals randomized to the PN arm.	Behavioral: Educational Materials; Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.; Behavioral: Patient Navigation (PN) - Less Intensive; The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment	Cancer screening defined as a breast, cervical, or colorectal cancer screening.	Up to Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Chau Trinh, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Patient Navigation
• Other Study ID Numbers: 22-01516

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 used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Madison.LeCroy@nyulangone.org. Data will also be available for 5 years at a data repository, appropriately selected with the guidance of Nicole Contaxis, NYULH Data Catalog Coordinator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• 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 Madison.LeCroy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. In addition, data will be available for 5 years at a data repository, appropriately selected with the guidance of Nicole Contaxis, NYULH Data Catalog Coordinator.
• 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