NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation
NCT ID: NCT05742178
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2160 participants
INTERVENTIONAL
2023-07-05
2026-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
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.
Educational Materials
Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
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.
Educational Materials
Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
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.
Interventions
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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.
Educational Materials
Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
21 Years
75 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Chau Trinh, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Bruce Rapkin
Role: primary
Other Identifiers
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22-01516
Identifier Type: -
Identifier Source: org_study_id