Perioperative Individually Tailored Psychological Intervention in Breast Cancer Patients Improves Psychological Indices and Molecular Biomarkers of Metastasis in Excised Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tumor gene expression signatures
研究概览
简要总结
This randomized controlled trial examined whether a perioperative individually tailored psychological intervention can reduce psychological distress and modulate pro-metastatic molecular processes in breast cancer patients undergoing surgery. Forty women with stage I-III breast cancer were randomized to receive either a 6-week individualized psychological intervention or standard nursing care. Primary outcomes included tumor gene expression profiles associated with adrenergic, inflammatory, and metastatic signaling pathways. Secondary outcomes included psychological distress, stress, and resilience measures assessed across multiple perioperative time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage I-III breast cancer
- •Scheduled for curative surgery
- •Age 20-80
排除标准
- •Metastatic disease
- •Neoadjuvant therapy
- •Other malignancy
- •Severe psychiatric conditions
研究组 & 干预措施
Psychological Intervention
Individually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses.
干预措施: Individually Tailored Perioperative Psychological Intervention (Behavioral)
Standard Care
Standard nursing staff attention without structured psychological intervention.
干预措施: Standard Nursing Care (Other)
结局指标
主要结局
Tumor gene expression signatures
时间窗: At surgery (tumor resection)
Transcriptional activity of pro-metastatic, inflammatory, and adrenergic signaling pathways in excised tumors assessed via RNA sequencing.
次要结局
- Psychological distress (BSI-18)(Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery)
- Self-reported stress level(Baseline, 1 day before surgery, 1 day after surgery, 3-4 weeks after surgery, and 3 months after surgery)
- Hope (Hope-18)(Baseline and 3-4 weeks after surgery)
- Perceived social support (MSPSS)(Baseline and 3-4 weeks after surgery)
- Fatigue (SF-36 subscale)(Baseline and 3-4 weeks after surgery)