An interventional study of Patient Navigation (PN) - More Intensive and Educational Materials in Cancer Screening, sponsored by NYU Langone Health. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Screening
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.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
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 · Behavioral: Educational Materials
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 · Behavioral: Patient Navigation (PN) - Less 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.
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.
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.
Time frame: Up to Month 6
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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