NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer Screening

Intervention / Treatment
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* Behavioral: Patient Navigation (PN) - More Intensive
* Behavioral: Educational Materials
* Behavioral: Patient Navigation (PN) - Less Intensive


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Navigation (PN)<br>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<br>* 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.<br>Behavioral: Educational Materials<br>* Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.<br>|
| Active Comparator: Less Intensive (LI)<br>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<br>* Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.<br>Behavioral: Patient Navigation (PN) - Less Intensive<br>* The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |