MADRE (Mammograms Available Due to Research and Education)
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: Educate, Empower.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer Screening. 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat Breast Cancer (BC) screening.
Подробное описание
To further test the added benefits of the empower approach relative to traditional educate approaches. Past community research has primarily focused on one-time BC screening among intervention participants. The design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat BC screening. The investigator will estimate the widespread effects of interventions by prospectively collecting data from network members not involved in the RCT. The investigator will also explore "active ingredients" that underlie intervention effects, including psychosocial, IS and network mechanisms. Overall, the investigator will demonstrate whether and how non-adherent individuals may "boost" intervention effects throughout their networks.
The investigator's goal is to further test the added benefits of the empower approach relative to traditional educate approaches. Past community research has primarily focused on one-time BC screening among intervention participants. The investigator's novel design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat BC screening. The investigator will estimate the widespread effects of interventions by prospectively collecting data from network members not involved in the RCT. The investigator will also explore "active ingredients" that underlie intervention effects, including psychosocial, IS and network mechanisms. Overall, the investigator will demonstrate whether and how non-adherent individuals may "boost" intervention effects throughout their networks.
Aim 1: Among 400 non-adherent individuals, the investigator will compare intervention effects on BC screening, using an individual RCT in a federally qualified health center (FQHC). The investigator will use the US Preventative Services Task Force (USPSTF) guidelines - i.e., 40-74 year-olds should obtain mammograms every 2 years.
Aim 2: Among 200 network members, the investigator will compare intervention effects on BC screening, based on the USPSTF guidelines.
Aim 3: The investigator will explore mechanisms of change underlying intervention effects on BC screening using IS measures, descriptive SNA, and structural equation models. If study arms are comparable, the investigator will examine which mechanisms may predict multilevel intervention effects across approaches.
Вмешательства
- Другое Educate
Education sessions - Другое Empower
Empowerment sessions
Первичные конечные точки
- Breast Cancer (BC) Screening (Aim 1) [Срок оценки: 1-4 years]
- Breast Cancer Screening (Aim 2) [Срок оценки: 1-4 years]
Критерии участия
Aim 1
Критерии включения
- female biological sex
- identification as Latinas
- non-adherence to USPSTF guidelines (42-74 years old, no mammogram in past 2 years, no previous BC diagnosis)
- no previous history of health volunteerism
- not a network member enrolled in Aim 2.
Критерии исключения
\* Not meeting at least one of the aforementioned Aim 1 inclusion criteria.
Aim 2.
Критерии включения
- female biological sex
- eligibility to obtain BC screenings by USPSTF guidelines (i.e., 40-74 years old, no personal BC history)
- referral from Aim 1 participants
- no previous history of health volunteerism
- no participation in the RCT (not an Aim 1 participant, no Session #3 attendance).
Критерии исключения
- Not meeting at least one of the aforementioned Aim 1 inclusion criteria.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Скрининг
Центры проведения
США · 2 центра
- Mile Square Health Center — Chicago
- University of Illinois Health — Chicago
Публикации
- McClellan SP, De La Paz E, Arroyo J, Montoya S, Perez J, Wright E, Moreno E, Padilla M, Kroenke CH, Rauscher GH, Neuschler E, Ganschow P, Stackhouse N, Atkins M, Dziak JJ, Neal JW, Lucio A, Molina Y. The "Mammograms Available Due to Resources and Education" (MADRE) Study: Rationale and Design. Contemp Clin Trials. 2025 Feb;149:107786. doi: 10.1016/j.cct.2024.107786. Epub 2024 Dec 22. PMID 39719248
Идентификаторы
NCT: NCT05841355 · 2022-0531