Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer
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: Mediterranean diet-based Intervention.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
- 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.
Подробное описание
Primary Objectives:
To determine the feasibility of a Mediterranean diet-based intervention adapted for underrepresented minority men with prostate cancer, defined based on the following process measures68:
* Enrollment (completion of 25 patient accrual within 2 years) * Retention (completion of the study through the 6-month time point, with ≥80% defined as successful) * Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).
Secondary Objectives:
To determine changes due to the Mediterranean diet intervention in the following measures:
* Mediterranean diet score (define using MEPA I calculated using VioScreen data) * Weight/BMI * QoL (EQ-5D-5L) * Physical activity (IPAS) * Non-invasive biomarkers * Gut microbiome * Metabolomics
To determine fidelity of intervention,62 including a description of patient comprehension, cognitive skills and perceived ability to change diet during the intervention.
Вмешательства
- Поведенческое Mediterranean diet-based Intervention
Through existing collaboration with the Harris Health system's innovative food pharmacy, participants will be provided fresh fruit, vegetables and other foods every other week during the study. Participants will receive olive oil and walnuts during the 8 week intervention (consistent with the PREDIMED6 intervention) to supplement their (and their families') diet during the 8-week intervention (while personalized education about diet, food choices and preparation is still occurring).
Первичные конечные точки
- Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year]
Критерии участия
Критерии включения
- Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment.
- Diagnosis within 12 months prior to enrollment OR
- Currently managed on active surveillance, with initial biopsy being <5 years from date of enrollment
- Self-identified Hispanic and/or Black/African American
- Patient at LBJ Hospital
Критерии исключения
- Special dietary requirements such that patient is unwilling to attempt dietary change
- Unwillingness to participate in study activities
- Inability to keep appointments
- Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Lyndon B Johnson Hospital — Houston
Идентификаторы
NCT: NCT06935097 · 2025-0331 · NCI-2025-02780