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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05742178
Other study ID # 22-01516
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 5, 2023
Est. completion date October 1, 2026

Study information

Verified date March 2024
Source NYU Langone Health
Contact Chau Trinh-Shevrin, DrPH
Phone 646-501-3480
Email chau.trinh@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2160
Est. completion date October 1, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: - Women between the ages of 21 and 75 years; - Men between the ages of 50 and 75 years; - Women (50-74 years) who have not had a mammogram in the past 24 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 50-75 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, or Chinese Mandarin; - Lives in East Flatbush (zip codes: 11236, 11203, 11212); Sunset Park (zip codes: 11215, 11220, 11232); Highbridge (zip code 10452); 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Albert Einstein College of Medicine Bronx New York
United States NYU Langone Health New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment Cancer screening defined as a breast, cervical, or colorectal cancer screening. Up to Month 6
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