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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Navigation (PN) | Experimental | 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. |
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| Less Intensive (LI) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation (PN) - More Intensive | Behavioral | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chau Trinh-Shevrin, DrPH | Contact | 646-501-3480 | chau.trinh@nyulangone.org | |
| Perla Chebli, PhD | Contact | 646-501-3524 | perla.chebli@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Chau Trinh, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States | |
| Albert Einstein College of Medicine |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Madison.LeCroy@nyulangone.org. Data will also be available for 5 years at a data repository, appropriately selected with the guidance of Nicole Contaxis, NYULH Data Catalog Coordinator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Madison.LeCroy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. In addition, data will be available for 5 years at a data repository, appropriately selected with the guidance of Nicole Contaxis, NYULH Data Catalog Coordinator.
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Educational Materials | Behavioral | Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed. |
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| Patient Navigation (PN) - Less Intensive | Behavioral | The PN intervention will be administered by trained, bilingual CHWs: they will screen participants for social needs and provide navigational support to social services. |
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| Recruiting |
| The Bronx |
| New York |
| 10461 |
| United States |
|
| D006298 | Health Services Administration |