NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

Last updated: January 29, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Educational Materials

Patient Navigation (PN) - Less Intensive

Patient Navigation (PN) - More Intensive

Clinical Study ID

NCT05742178
22-01516
  • Ages 21-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 smearin the last 3 years (21-64 years old) or HPV test in the last 5 years (30-64 yearsold), 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, orcolonoscopy past 10 years);

  • Men not up-to-date on colorectal cancer screening (FOBT/FIT past year, computerizedtomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10years);

  • Must speak either English, Spanish, Haitian-Creole, French, or Chinese (Mandarin andCantonese);

  • Lives in East Flatbush (zip codes: 11236, 11203, 11212, 11226); Sunset Park (zipcodes: 11215, 11220, 11232); Highbridge (zip code 10452, 10455, 10451); orMorrisania (zip codes: 10456, 10459)

Exclusion

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-terminstitution 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

Total Participants: 2160
Treatment Group(s): 3
Primary Treatment: Educational Materials
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • Albert Einstein College of Medicine

    Bronx, New York 10461
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.