NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation
NYC CONNECT
1 other identifier
interventional
2,160
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
December 18, 2025
December 1, 2025
3.2 years
February 15, 2023
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Patient Navigation (PN)
EXPERIMENTALParticipants 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.
Less Intensive (LI)
ACTIVE COMPARATORParticipants 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.
Interventions
Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Centers for Disease Control and Preventioncollaborator
Study Sites (2)
NYU Langone Health
New York, New York, 10016, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chau Trinh, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2023
First Posted
February 23, 2023
Study Start
July 5, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- 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 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.
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.