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NCT Number: NCT05742178

NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

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.

Recruiting

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Key information

Conditions

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment

    Time frame: Up to Month 6

    Cancer screening defined as a breast, cervical, or colorectal cancer screening.

Study contacts

Contact information is provided by the study sponsor or research team.

Chau Trinh-Shevrin, DrPH

CONTACT

[email protected]

646-501-3480

Perla Chebli, PhD

CONTACT

[email protected]

646-501-3524

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: NYC CONNECT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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