Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The memory components and memory loss mechanisms by questionnaires
研究概览
简要总结
The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Major patients under the age of 70;
- •Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer
- •Radiotherapy completed for about 6 months
- •Level of study 3 "end of primary studies" minimum (Barbizet scale);
- •French mother tongue;
- •Menopausal women for at least 1 year before the selection visit
- •Absence of primary cancer of the central nervous system or brain metastases;
- •Absence of previous neurological damage;
- •Absence of personality disorders and progressive psychiatric pathology;
- •Having signed the informed consent to participate in the study.
排除标准
- •Primary cancer other than breast
- •Metastatic cancer
- •Treated by chemotherapy
- •Cognitive function disorders pre-existing to cancer diagnosis
- •Patients with paraneoplastic syndrome;
- •Evolutionary psychiatric pathology;
- •Refusal of participation;
- •Patients unable to respond to cognitive tests;
- •Drug use or excessive consumption of alcohol.
研究组 & 干预措施
Group A
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
干预措施: Neuropsychological, psycho-pathological and quality of life assessments (Other)
Group A
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
干预措施: Hormonotherapy (Drug)
Group B
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
干预措施: Neuropsychological, psycho-pathological and quality of life assessments (Other)
Healthy volunteers
Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
干预措施: Neuropsychological, psycho-pathological and quality of life assessments (Other)
结局指标
主要结局
The memory components and memory loss mechanisms by questionnaires
时间窗: 6 months after the end of radiotherapy
次要结局
- The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires(6 months after the end of radiotherapy)
- The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires(6 months after the end of radiotherapy)
- The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires(6 months after the end of radiotherapy)