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Идёт набор NCT07630935

Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation

Наблюдательное Breast Neoplasms Diagnosis

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: Personalized Prevention Plan.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms Diagnosis. Базовые параметры: от 18 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study evaluates adherence to a personalized prevention plan in female night shift workers at increased risk of breast cancer. Night shift work is associated with circadian disruption and increased cancer risk, as well as cardiovascular and reproductive health risks. Participants attend an initial consultation including clinical assessment and development of a personalized prevention plan targeting modifiable risk factors such as alcohol consumption, physical activity, smoking, diet, and weight. Follow-up is conducted remotely over 5 years to assess adherence to recommendations and screening. Participant satisfaction and adherence to additional consultations are also evaluated.

Подробное описание

Breast cancer is the most common cancer among women, and prognosis depends on early detection. Night shift work is associated with circadian rhythm disruption and increased cancer risk.

This single-center interventional study evaluates adherence to a personalized prevention plan (PPP) developed during an initial consultation. This consultation includes a review of medical history, a lifestyle assessment, and a physical examination.

The PPP targets modifiable risk factors, including smoking, alcohol consumption, diet, physical activity, and weight.

Participants are followed for 5 years, with assessments at 1, 2, 3, and 5 years. Adherence is defined as the implementation of at least one recommendation or the completion of prescribed screening tests.

Secondary objectives include assessing satisfaction with and adherence to cardiology and fertility consultations when recommended.

Вмешательства

  • Поведенческое Personalized Prevention Plan
    Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening

Первичные конечные точки

  • Adherence to Personalized Prevention Plan established during the initial risk assessment consultation [Срок оценки: At 1, 2, 3 and 5 years.]
Вторичные конечные точки (4)
  • Overal patient satisfaction [Срок оценки: At 1, 2, 3 and 5 years]
  • Participant satisfaction with the adapted consultation to night work [Срок оценки: At 1, 2, 3 and 5 years.]
  • Screening adherence to a cardiovascular consultation recommendation [Срок оценки: At 1, 2, 3 and 5 years.]
  • Screening adherence to a fertility consultation consultation recommendation [Срок оценки: At 1, 2, 3 and 5 years.]

Критерии участия

Критерии включения

  • Female participants aged 18 years or older
  • Night shift workers at Pitié-Salpêtrière Hospital
  • Attending consultation for breast cancer risk assessment PGRC
  • Affiliated with a social security system
  • No personal history of breast cancer
  • Provided informed consent (non-opposition procedure according to French regulations)

Критерии исключения

  • Pregnant or breastfeeding women
  • Individuals under legal protection or deprived of liberty
  • Individuals without standard health insurance coverage

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Pitié Salpêtrière hospital — Paris

Идентификаторы

NCT: NCT07630935 · APHP260459

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗