Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 6
- 主要终点
- Course of cognitive function
研究概览
简要总结
The study will investigate the impact of cancer-related stress and its consequences (acute and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients shall be evaluated.
详细描述
Primary hypothesis:
*The adverse effects of cancer and cancer therapy on cognitive function in breast cancer patients are entirely or partly mediated by stress and the ensuing dysfunction of the HPA-axis.
Secondary objectives:
- Determining the effect of cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on the HPA-axis in breast cancer patients
- Determining the effect of cognitive dysfunction assessed with neuropsychological tests, cancer diagnosis, chemotherapy, disease-related stress, acute stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on subjective cognitive function in breast cancer patients
- Prevalence of acute stress response, posttraumatic stress disorder and posttraumatic stress symptoms, and extent of cancer-specific stress in breast cancer patients treated with or without chemotherapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •not fluent in German
- •substance abuse
- •history of psychosis
- •history of neurologic disorder
- •previous systemic cancer treatment
- •Addison' disease
- •Cushing's syndrome
结局指标
主要结局
Course of cognitive function
时间窗: 12 months
Performance on a battery of cognitive tests
次要结局
- Course of subjective cognitive function(12 months)
- Course of the stress response(12 months)
- Course of the HPA-axis function(12 months)
研究者
Kerstin Hermelink
Study Principal Investigator
Ludwig-Maximilians - University of Munich