NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Educational Materials
  Both PN and LI participants will receive tailored educational materials around cancer screening and SDH resources as needed.
• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 2 центра

• NYU Langone Health — New York
• Albert Einstein College of Medicine — The Bronx

Идентификаторы

NCT: NCT05742178 · 22-01516

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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