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.
Brief Title
NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation
Central Contacts
Central Contact Role
Contact
Central Contact Phone
646-501-3480
Central Contact Email
chau.trinh@nyulangone.org
Central Contact Role
Contact
Central Contact Phone
646-501-3524
Central Contact Email
perla.chebli@nyulangone.org
Completion Date
Completion Date Type
Estimated
Conditions
Cancer Screening
Eligibility Criteria
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).
* 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).
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
21 Years
NCT Id
NCT05742178
Org Class
Other
Org Full Name
NYU Langone Health
Org Study Id
22-01516
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation Randomized Controlled Trial (NYC CONNECT)
Primary Outcomes
Outcome Description
Cancer screening defined as a breast, cervical, or colorectal cancer screening.
Outcome Measure
Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment
Outcome Time Frame
Up to Month 6
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Bruce Rapkin
Investigator Email
bruce.rapkin@einsteinmed.edu
Investigator Phone
718-920-5663