Psychological Distress in Malignant Tumor Patients: Effects on Treatment Adherence, Outcomes, and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) by mRECIST (%)
研究概览
简要总结
The goal of this observational study is to learn about the Psychological Distress in Malignant Tumor Patients about Effects on Treatment Adherence, Outcomes, and Quality of Life. The main question it aims to answer is:
Does Psychological Distress affect Malignant Tumor Patients' Effects on Treatment Adherence, Outcomes, and Quality of Life? Malignant Tumor Patients with or without Psychological Distress will answer GAD-7 and PHQ-9 and their Treatment Adherence, Outcomes, and Quality of Life be recorded for 3 years.
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
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Confirmed malignant tumors by imaging or pathology (such as hepatobiliary carcinoma, gastric cancer, breast cancer, lung cancer, etc.)
- •(2) Planning to receive or currently undergoing systemic treatment (such as surgery, chemotherapy, TACE, targeted therapy, etc.)
- •(3) Age ≥18 years old
- •(4) Sign the informed consent form and voluntarily participate in this study
排除标准
- •(1) Combined with severe systemic diseases (such as severe cardiovascular and cerebrovascular diseases)
- •(2) There is severe cognitive impairment and it is impossible to complete the questionnaire assessment
- •(3) Incomplete clinical data or loss to follow-up
结局指标
主要结局
Objective Response Rate (ORR) by mRECIST (%)
时间窗: at 4-12 weeks after treatment initiation.
Proportion of participants achieving complete response (CR) or partial response (PR) based on mRECIST criteria, measured on contrast-enhanced CT/MRI.
次要结局
未报告次要终点
研究者
Gang Chen, MD
M.D., Ph.D., Professor
First Affiliated Hospital of Wenzhou Medical University