The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR) rate
研究概览
简要总结
This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.
详细描述
Breast cancer is the most common malignant tumor among women. Approximately 19% to 30% of patients with breast cancer achieve a pathological complete response (pCR) following neoadjuvant therapy, while about 5% to 20% of patients experience disease progression. Increasing evidence suggests the significant role of psychological factors in influencing cancer treatment outcomes. Cancer patients often experience emotional distress, including fear of relapse, anxiety, depression, and low self-esteem, which may persist for many years. Statistics indicate that the incidence of anxiety and depression among cancer patients is 49.69% and 54.90%, respectively, significantly higher than that of healthy individuals (anxiety: 18.37%, depression: 17.50%) in China. There are indications that emotional issues may be linked to cancer treatment, although the underlying mechanisms remain unclear.
This study aims to investigate the relationship between anxiety and depression and the effectiveness of standard neoadjuvant therapy in patients with breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.Age ≥ 18 years; 2.Histological and/or cytological diagnosis of breast cancer; 3.Treatment niave patients; 4.To receive standard neoadjuvant therapy; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ; 7.Informed and agreed to participate in the study;
排除标准
- •Breast cancer has not been confirmed through histological or cytological examinations.
- •2.Other breast cancer conditions that do not receive neoadjuvant therapy. 3.Combined with other malignant tumors. 4.Concurrent acute or chronic psychiatric disorders, along with having received antidepressant or anti-anxiety therapy within the past month.
- •5.Participants must not have engaged in any other clinical trials in the past month, unless those trials are observational or non-interventional in nature.
结局指标
主要结局
Pathologic complete response (pCR) rate
时间窗: 2 years
pCR is defined as the absence of viable tumor cells in both the tumor bed and lymph nodes. The pCR rate refers to the percentage of patients who achieve this complete response.
次要结局
- Quality of life(2 years)
- peripheral stress biomarkers(2 years)
- Objective Response Rate (ORR)(2 years)
研究者
Caigang Liu
Director of oncology
Shengjing Hospital