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Recruiting NCT05742178

NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

No phase Interventional Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Navigation (PN) - More Intensive, Educational Materials, Patient Navigation (PN) - Less Intensive.
Who it may be relevant to
Registry conditions: Cancer Screening. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Percentage of Participants who Receive at Least 1 Cancer Screening at 6 Months After Study Enrollment [Time frame: Up to Month 6]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 2 centers
  • NYU Langone Health — New York
  • Albert Einstein College of Medicine — The Bronx

Identifiers

NCT: NCT05742178 · 22-01516

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗