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

NYU Langone Health

Status: Enrolling

Conditions: Cancer Screening

Treatments: Behavioral: Patient Navigation (PN) - More Intensive; Behavioral: Educational Materials; Behavioral: Patient Navigation (PN) - Less Intensive

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05742178

22-01516

Details and patient eligibility

About

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.

Enrollment: 2,160 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,160 participants in 2 patient groups

Patient Navigation (PN)

Experimental group

Description:

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.

Treatment:

Behavioral: Educational Materials

Behavioral: Patient Navigation (PN) - More Intensive

Less Intensive (LI)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Patient Navigation (PN) - Less Intensive

Behavioral: Educational Materials