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Идёт набор NCT07238088

Active Mammography and Counseling

Без фазы С лечением Breast Cancer Prevention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Individual Education, Community Navigation, Healthcare Providers Educational Intervention.
Кому может быть актуально
Состояния в реестре: Breast Cancer Prevention. Базовые параметры: 40 лет — 74 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пуэрто-Рико
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Monitoreo Activo de Mamografía y Orientación

Обзор

The Puerto Rico Community Engagement Alliance (PR-CEAL) is an NIH-funded initiative which aims to improve health literacy and healthcare access across Puerto Rico. In 2024, the program developed a new study which goal is to improve breast cancer screening rates in Puerto Rico titled Monitoreo Activo de Mamografía y Orientación (MAMO). This multi-level study will recruit non-adherent women based on residence, age (40 to 74 years old), and having had two or more years since their last breast cancer screening. The intervention will focus on 39 municipalities with screening rates below the median, through three different levels: educational, navigation, and integration. At the educational level, the intervention will employ a community-based recruitment strategy led by Community Health Workers (CHWs), who will identify eligible women at community venues and conduct follow-up via telephone to provide educational support. Drawing on findings from a previous pilot study and addressing barriers specific to non- adherent women, the navigation-level intervention will incorporate the role of a Community Navigator to deliver tailored support and facilitate breast cancer screening uptake through collaboration with local networks and partnerships. The integration-level intervention will build upon the educational and navigation components by enhancing knowledge, attitudes, skills, and organizational processes within Federally Qualified Health Clinics (FQHCs). This component is designed to foster a supportive healthcare environment that encourages routine mammography screening. The integration-level intervention will be implemented in four FQHCs across PR.

Вмешательства

  • Поведенческое Individual Education
    This component was developed using Intervention Mapping (IM) as a methodological framework and adapted from two evidence-based programs: "Unidas por la Vida" and "Nuestra Cocina: Mesa Buena, Vida Sana". The intervention includes one-on-one educational sessions led by Community Health Workers (CHWs), who will use tailored educational materials to guide participants and provide them with a take-home kit to promote and assist with mammography scheduling.
  • Другое Community Navigation
    At this level, a community navigator service will be implemented to help participants overcome barriers to mammography screening. Seven community navigators will provide personalized support to address common challenges, including scheduling appointments, transportation, and access to healthcare services. These interventions leverage culturally tailored training to enable navigators to address barriers to breast cancer screening and enhance health literacy within their communities. The study int
  • Другое Healthcare Providers Educational Intervention
    The provider-level interventions will engage both clinical and administrative personnel who are actively employed at Federally Qualified Health Clinics (FQHCs). Two educational modules are being developed for the integration-level intervention. The educational content is designed to address provider-level barriers to breast cancer screening-an area that remains underexplored in the literature compared to patient-level factors. By engaging healthcare providers in FQHCs, this level aims to ensure

Первичные конечные точки

  • Number of participants who self-reported having had a mammogram [Срок оценки: Up to 6 months]
Вторичные конечные точки (1)
  • Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration Levels [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

  • Women (biological sex at birth) aged 40- 74
  • Residing in one of 39 municipalities across Puerto Rico whose having a low breast cancer screening rate below the median (38.6%): Aibonito, Arecibo, Barceloneta, Caguas, Camuy, Comerío, Corozal, Florida, Las Piedras, Loíza, Naguabo, Vieques, Villalba, Añasco, Carolina, Cayey, Dorado, Guayanilla, Guaynabo, Isabela, Juana Diaz, Juncos, Luquillo, Manatí, Peñuelas, Quebradillas, Cabo Rojo, Canóvanas, Ceiba, Ciales, Coamo, Culebra, Fajardo, Morovis, Ponce, Sabana Grande, San Juan, Santa Isabel, and Trujillo Alto.
  • Overdue for breast cancer screening by one or more years, in accordance with annual guidelines
  • Adequate cognitive orientation as verified by a brief version of the Mini-Mental State Examination
  • Access to a telephone for follow-up and communication
  • Ability to read and comprehend Spanish to engage with educational materials.

Критерии исключения

  • Women outside the specified age range (40-74)
  • Up to date in breast cancer screening according to the annual recommendations.
  • No cognitive orientation
  • Participants without access to a telephone
  • Unable to read and comprehend Spanish
  • Women undergoing active cancer treatment
  • History of radical mastectomy

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Пуэрто-Рико · 1 центр
  • UPR-Comprehensive Cancer Center — San Juan

Идентификаторы

NCT: NCT07238088 · 2409000060 · SUB-OTA No. 6922-03-COVID-S026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗