An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 512
- 试验地点
- 6
- 主要终点
- Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
研究概览
简要总结
Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years 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
- •Be pathologically or clinically diagnosed as primary lung cancer before surgery;
- •Plan to undergo a surgical procedure.
排除标准
- •Aged younger than 18;
- •Diagnosis of cognitive impairment or unable to understand the study requirements.
结局指标
主要结局
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
时间窗: less than 6 weeks
We will use MD Anderson Symptom Inventory lung cancer module (MDASI-LC) to longitudinally assess the perioperative symptom burden for lung cancer patients. The symptom burden will be profiled as symptom severity, frequency of moderate to severe symptom and its interference with daily functioning.
次要结局
未报告次要终点
研究者
Xiaojun Yang
Clinical Professor and Principal Investigator
Sichuan Cancer Hospital and Research Institute