Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire.
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire.
时间窗: Up to 6 months after the end of the physical activity program
Mean differences on the questionnaire will be evaluated. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item validated tool used to assess the physical, psychological, and social functions of cancer patients. Higher scores on functional scales and the global health status represent a higher/better level of functioning, while higher scores on symptom scales represent a higher level of symptomatology.
次要结局
- Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form)(Up to 6 months after the end of the physical activity program)
- Change from Baseline in Physical Activity Levels(Up to 6 months after the end of the physical activity program)
- Change from Baseline in Dietary Habits and Nutritional Intake(Up to 6 months after the end of the physical activity program)
- Change from Baseline in Blood Test Results(Up to 6 months after the end of the physical activity program)
- incidence of Hormonal Therapy-Related Toxicities(Through the end of the program and follow-up (up to 6 months).)
- Change from Baseline in BMI(Up to 6 months after the end of the physical activity program)
- Change from Baseline in body measures(Up to 6 months after the end of the physical activity program)
- Change from Baseline in BIA(Up to 6 months after the end of the physical activity program)