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

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05742178

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

2,160

Enrollment

Location

Arms

Anticipated Duration (Months)

51.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Screening	Behavioral: Patient Navigation (PN) - More Intensive Behavioral: Educational Materials Behavioral: Patient Navigation (PN) - Less Intensive	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Behavioral: Educational Materials Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
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.	Behavioral: Educational Materials Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed. Behavioral: 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.

Arm

Intervention/Treatment

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.

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.

Behavioral: Educational Materials

Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.

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.

Behavioral: Educational Materials

Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment [Up to Month 6]
Cancer screening defined as a breast, cervical, or colorectal cancer screening.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
Centers for Disease Control and Prevention

Investigators

Principal Investigator: Chau Trinh, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05742178

Other Study ID Numbers:

22-01516

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 23, 2023