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Trial Title:
NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation
NCT ID:
NCT05742178
Condition:
Cancer Screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Navigation (PN) - More Intensive
Description:
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.
Arm group label:
Patient Navigation (PN)
Intervention type:
Behavioral
Intervention name:
Educational Materials
Description:
Both PN and LI participants will receive tailored educational materials around cancer
screening and SDH resources as needed.
Arm group label:
Less Intensive (LI)
Arm group label:
Patient Navigation (PN)
Intervention type:
Behavioral
Intervention name:
Patient Navigation (PN) - Less Intensive
Description:
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 group label:
Less Intensive (LI)
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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
21 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Albert Einstein College of Medicine
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bruce Rapkin
Phone:
718-839-7453
Email:
bruce.rapkin@einsteinmed.org
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Start date:
July 5, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Collaborator:
Agency:
Centers for Disease Control and Prevention
Agency class:
U.S. Fed
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05742178
