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Идёт набор NCT07539038

Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients

— Наблюдательное Breast 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Breast Cancer. 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
Италия
Следующий шаг
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Обзор

The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life. This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).

Подробное описание

The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life.

This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).

Первичные конечные точки

  • Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire. [Срок оценки: Up to 6 months after the end of the physical activity program]
Вторичные конечные точки (8)
  • Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form) [Срок оценки: Up to 6 months after the end of the physical activity program]
  • Change from Baseline in Physical Activity Levels [Срок оценки: Up to 6 months after the end of the physical activity program]
  • Change from Baseline in Dietary Habits and Nutritional Intake [Срок оценки: Up to 6 months after the end of the physical activity program]
  • Change from Baseline in Blood Test Results [Срок оценки: Up to 6 months after the end of the physical activity program]
  • incidence of Hormonal Therapy-Related Toxicities [Срок оценки: Through the end of the program and follow-up (up to 6 months).]
  • Change from Baseline in BMI [Срок оценки: Up to 6 months after the end of the physical activity program]
  • Change from Baseline in body measures [Срок оценки: Up to 6 months after the end of the physical activity program]
  • Change from Baseline in BIA [Срок оценки: Up to 6 months after the end of the physical activity program]

Критерии участия

Критерии включения

  • Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy
  • Female patients ≥18 years of age
  • Written informed consent must be obtained before any study-related assessment is performed
  • Participation to the Medicina and Sport physical activity program organized by Andos Pordenone

Критерии исключения

  • Patients with early hormone receptor negative breast cancer
  • Patients with early hormone receptor positive breast cancer receiving chemotherapy
  • Patients with advanced/metastatic breast cancer.
  • Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias).
  • Patients with history of vertebral and/or femoral fractures
  • Patients with CVDs not optimally controlled by medical therapy

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Centro di Riferimento Oncologico di Aviano — Aviano

Идентификаторы

NCT: NCT07539038 · CRO-2022-061

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗