NCT01064427Unknown不适用
Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy
Central Hospital, Nancy, France3 个研究点 分布在 1 个国家目标入组 557 人开始时间: 2008年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 557
- 试验地点
- 3
- 主要终点
- The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
研究概览
简要总结
The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18 years and older
- •newly diagnosed with stage I-IIIA breast adenocarcinoma
- •have undergone surgery
- •WHO performance status score equal or lower than 2
- •able to provide informed consent
- •speak French and able to complete self-report questionnaires
排除标准
- •pregnancy
- •bilateral breast cancer
- •metastatic breast cancer
- •patients who received neoadjuvant chemotherapy
- •known psychiatric disease or dementia
- •no previous history of cancer
结局指标
主要结局
The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
时间窗: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
次要结局
- Questionnaires regarding personality traits (LOT "Life Orientation Test" and the trait-version of the STAI "State Trait Anxiety instrument"), Quality of life questionnaire(EORTC QLQ-C30), and the state-version of the STAI will be also completed.(For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment)
研究者
研究点 (3)
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