NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05742178
Status
Recruiting

Conditions

  • Cancer Screening

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Patient Navigation (PN) - More Intensive — BEHAVIORAL
    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.
  • Educational Materials — BEHAVIORAL
    Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
  • Patient Navigation (PN) - Less Intensive — BEHAVIORAL
    The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services.

Study Details

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.

Key Dates

Start date
Jul 5, 2023
Status verified
Dec 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
2,160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment [ Time Frame: Up to Month 6 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-
Albert Einstein College of MedicineThe BronxNew York10461
Bruce Rapkin
718-839-7453

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