NCT02862990已完成不适用
Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 7
- 主要终点
- To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility
研究概览
简要总结
To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.
详细描述
To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:
- Age at diagnosis
- Number of children
- Will of having children
- Marital status
- Scholarity
- Period of time from the diagnosis
- Time of the last menstruation period
- Chemotherapy administration
- Clinical staging at the diagnosis
- Pathological evaluation
- Documentation of the cancer therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with age ≥ 18 and ≤ 40
- •Indication of (neo) adjuvant chemotherapy
- •Prior chemotherapy treatment
- •Patients with menstrual periods in the last 6 months
- •In use of contraceptive methods
- •Without breast cancer recurrence
- •Capacity to read and understand the informed consent
排除标准
- •Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
- •Patients whom initiated chemotherapy treatment before entering the study
- •Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
- •Previous diagnosis of infertility
结局指标
主要结局
To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility
时间窗: Baseline and 1 year after after the first interview
次要结局
- Age when diagnosed(Baseline and 1 year after the first interview)
- Scholarity(Baseline)
- Period of time since the diagnosis(Baseline)
- Period of time from the last menstruation period(Baseline and 1 year after the first interview)
- Description of quality of life of patients with the EORTC QLQ-BR23(Baseline and 1 year after the first interview)
- Infertility risk for breast cancer patients after accepting chemotherapy(Baseline and 1 year after the first interview)
- Minimal percentage of cure necessary for patients accept the chemotherapy treatment(Baseline and 1 year after the first interview)
- Number of children(Baseline and 1 year after the first interview)
- Desire to have kids(Baseline and 1 year after the first interview)
- Marital status(Baseline)
- Chemotherapy scheme administration(Baseline and 1 year after the first interview)
研究者
研究点 (7)
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