NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

Cancer Screening Clinical Trial

— NYC CONNECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742178
• Other study ID #: 22-01516
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Cancer Screening

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