Development and Evaluation of Comprehensive Care Program for Their Return to Normal Life and Community Among Lung Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Mental adjustment to cancer at 6 months after surgery
研究概览
简要总结
The purpose of this study is to develop a comprehensive care program for their return to normal life and community among lung cancer survivors and evaluate the effectiveness of the program.
详细描述
Lung cancer patients scheduled for curative surgery will be enrolled in this study. The comprehensive care program will be developed, and provided to the intervention group before and after surgery. Outcomes will be assessed 6 months and 1 year after surgery. To evaluate the effectiveness of the program, a control group will be enrolled first and used as a comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients diagnosed with non-small cell lung cancer(NSCLC) and scheduled for curative resection.
- •NSCLC with clinical stage Ⅰ-Ⅲ
- •Patients who understood the study and gave written informed consent.
排除标准
- •Recurred lung cancer
- •Patients with extra-pulmonary synchronous double primary cancer.
- •Patients with history of other cancer diagnosis or treatment in the last 3 years.
- •Drop Criteria:
- •When surgery was canceled or pathologic stage IV was confirmed after surgery.
- •When the tumor was not found to be non-small cell lung cancer, including benign tumor, after surgery
- •Withdrawal informed consent.
结局指标
主要结局
Mental adjustment to cancer at 6 months after surgery
时间窗: 6 months after surgery
The Mini-Mental Adjustment to Cancer (Mini-MAC) scale, a short form instrument derived from the MAC and designed to measure coping with cancer. The scale consists of 29 items and 5 sub-dimensions as follows: Fighting spirit, helplessness/hopelessness, anxious preoccupation, fatalism and cognitive avoidance. The mini-MAC is a Likert type scale with four response options: (1) definitely does not apply to me (2) does not apply to me (3) applies to me (4) definitely applies to me.
次要结局
- Quality of life (EORTC QLQ-C30)(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Lung cancer specific symptoms(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Dyspnea (mMRC)(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Dyspnea (CAT)(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Unmet Needs(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Anxiety and depression(Before surgery (baseline) and 6, 12 months after surgery)
- Physical Activity(Before surgery (baseline) and 1, 6, 12 months after surgery)
- Mental adjustment to cancer(Before surgery (baseline) and 12 months after surgery)
- Distress(Before surgery (baseline) and 1, 6, 12 months after surgery)
研究者
Dong Wook Shin
Professor of Family Medicine
Samsung Medical Center