The European Organisation for Research and Treatment of Cancer: Module Development for Metastatic Breast Cancer (Phase I-IIIa/b)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 568
- 试验地点
- 22
- 主要终点
- Quality of life of females with metastatic breast cancer
研究概览
简要总结
The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adult females aged 18 years or over.
- •Have a diagnosis of MBC (Breast cancer that has spread to another part of the body), including de novo MBC patients. Patients with brain metastases will be included, providing there is no associated major cognitive impairment.
- •Have received (patients under observation) or currently receiving treatment for MBC, including chemotherapy, hormone therapy, targeted agents (anti-HER2, CDK4/6 inhibitors, mTOR/PIK3CA inhibitors, PARP inhibitors, immune therapy), radiotherapy and combinations.
- •Conversant in the language of questionnaire administration.
- •Have the capacity to give informed consent.
排除标准
- •Patients diagnosed with early stage breast cancer.
- •Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation in interviews.
- •Patients previously involved in Phase I.
结局指标
主要结局
Quality of life of females with metastatic breast cancer
时间窗: 1 month
次要结局
未报告次要终点
研究者
Galina Velikova
Professor Galina Velikova
University of Leeds