NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

NCT ID: NCT05742178

Last Updated: 2025-12-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

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.

Group Type EXPERIMENTAL

Patient Navigation (PN) - More Intensive

Intervention Type 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

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Educational Materials

Intervention Type BEHAVIORAL

Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.

Patient Navigation (PN) - Less Intensive

Intervention Type 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.

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.

Intervention Type BEHAVIORAL

Educational Materials

Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chau Trinh-Shevrin, DrPH

Role: CONTACT

Phone: 646-501-3480

Email: [email protected]

Perla Chebli, PhD

Role: CONTACT

Phone: 646-501-3524

Email: [email protected]

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