Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change from baseline quality of life during breast cancer treatment
研究概览
简要总结
Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages.
However, MBC benefits from therapeutics that improve patients' quality of life and even improve overall survival. The main objectives of this prospective study are :
- to evaluate the evolution over time of the quality of life of patients treated for positive hormonal receptors (RH+) metastatic breast cancer, according to the therapeutic class ;
- to evaluate the psychological vulnerability of these patients since the announcement of their metastatic diagnosis and during their treatments. Finally, when interviewing oncologists, to know the factors involved in a treatment change decision process for the same patient.
详细描述
Studying quality of life over time in patients followed for metastatic breast cancer will identify when a person may feel most vulnerable in their experience of the disease and treatment. A specific and adapted support can thus be set up throughout the disease, from the diagnosis and during the different phases of treatment.
Patients will benefit from a longitudinal follow-up determined according to the treatments. For example :
Chemotherapy : After the first assessment time at 1 month from diagnosis, patients receiving chemotherapy treatment are seen every 3 months.
Hormone therapy : After the first assessment time at 1 month from diagnosis, patients receiving hormone therapy are seen every 2 months.
Each type of treatment has its own schedule based on medical consultation times. At each change of treatment, from chemotherapy to hormone therapy or vice versa, the assessment times are determined according to the nature of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Histologically confirmed diagnosis of invasive breast cancer (=infiltrant). NB: Mixed histologies are allowed
- •Adult women (≥ 18 years),
- •Positive hormonal receptors (Estrogen receptors and/or Progesterone receptors ≥10%) and HER2 negative
- •Patient in need of a 1st metastatic treatment line NB: Patients may have received prior treatment for their cancer, but not for their metastatic disease.
- •Performance status ≤ 1 (world health organization)
- •Patients affiliated to a Social Security,
- •Obtaining the patient's signed written consent
排除标准
- •Patient with non-metastatic breast cancer,
- •Negative hormonal receptors or HER2 positive
- •Psychiatric history with specialist diagnosis
- •Pregnant or nursing patient
- •Patients who cannot be followed regularly for psychological reasons (cognitive problems preventing completion of questionnaires), or because of geographical remoteness.
- •Person deprived of liberty or adult under guardianship
结局指标
主要结局
Change from baseline quality of life during breast cancer treatment
时间窗: 3 years
quality of life assessed using QLQ-C30 Questionnaire
Change from baseline psychological vulnerability during breast cancer treatment
时间窗: 3 years
Psychological vulnerability assessed using STAI questionnaire
次要结局
- number of therapeutic class treatment prescribed during breast cancer treatment(3 years)