Living After Lung Surgery: Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Postoperative dyspnea
研究概览
简要总结
The goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery.
The main questions it aims to answer are:
- Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have less postoperative dyspnea than patients that undergo lobectomy?
- Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo lobectomy?
- Do patients with stage I NSCLC that undergo VATS segmentectomy or lobectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo RATS segmentectomy or lobectomy?
Participants already undergoing surgical intervention as part of their regular medical care for resectable lung cancer will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
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
- •Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.
排除标准
- •Thoracic surgery in the previous year
- •Neoadyuvant treatment
- •Failure to complete preoperative questionnaires
研究组 & 干预措施
Segmentectomy
Patients with cI NSLSC that undergo minimally invasive segmentectomy
Lobectomy
Patients with cI NSLSC that undergo minimally invasive lobectomy
结局指标
主要结局
Postoperative dyspnea
时间窗: It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
The postoperative dyspnea score will be calculated from the 33-35 items of the EORTC QLQ-LC29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 29) questionnaire and standardized to a 0-100 score. These items assess dyspnoea in three modalities: during rest, walking and climbing stairs in the preceding week. In each setting dyspnea is quantified from 1 (not at all short or breath) to 4 (very much short of breath), therefore a higher score indicates a higher level of dyspnea.
次要结局
- Quality-Adjusted Life Years (QALYs)(Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.)
- Physical Functioning(Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.)
研究者
Sara Fra Fernandez
Principal Investigator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal