Recruiting

PN & LI

Sponsor:

NYU Langone Health

Code:

NCT05742178

Conditions

Cancer Screening

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Patient Navigation (PN) - More Intensive

Educational Materials

Patient Navigation (PN) - Less Intensive

Study Details

Brief summary:

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.

Conditions

Cancer Screening

Study ID

NCT05742178

Start date

Jul 5, 2023

Status verified date

Dec, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

2160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Chau Trinh-Shevrin, DrPH

646-501-3480chau.trinh@nyulangone.org

Perla Chebli, PhD

646-501-3524perla.chebli@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Bruce Rapkin

718-839-7453bruce.rapkin@einsteinmed.org

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-18.