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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Albert Einstein College of Medicine
RECRUITING
The Bronx
Contact Information
Primary
Chau Trinh-Shevrin, DrPH
chau.trinh@nyulangone.org
646-501-3480
Backup
Perla Chebli, PhD
perla.chebli@nyulangone.org
646-501-3524
Time Frame
Start Date: 2023-07-05
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 2160
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov