A Prospective Observational Study on Symptom Burden in Lung Cancer Patients Undergoing Definitive Chemoradiotherapy: Insights From Electronic Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer
研究概览
简要总结
This prospective observational study aims to evaluate symptom burden and symptom clusters among lung cancer patients undergoing definitive concurrent chemoradiotherapy (CRT), based on electronic patient-reported outcomes (ePROs). Patients will complete the validated MDASI-LC and EQ-5D instruments weekly from baseline through the end of CRT and for 12 weeks post-treatment. The study will characterize the longitudinal trajectories of symptom severity and interference, identify distinct symptom clusters and their temporal patterns, and explore patient-level predictors of symptom burden. The findings may support the development of personalized symptom management strategies and improve quality of life during and after CRT.
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
- •Pathologically confirmed unresectable stage III NSCLC or limited-stage SCLC
- •Age ≥ 18 years
- •Receiving definitive chemoradiotherapy
- •Able and willing to complete electronic questionnaires
- •Provided written informed consent
排除标准
- •Severe comorbidities (heart, liver, kidney)
- •Psychiatric illness or cognitive impairment
- •Prior chest or mediastinal radiotherapy
结局指标
主要结局
Longitudinal trajectory of symptom burden over time based on M. D. Anderson Symptom Inventory-Lung Cancer
时间窗: Baseline, weekly during CRT (weeks 1-6), and weekly for 12 weeks after CRT.
M. D. Anderson Symptom Inventory-Lung Cancer:Scale range 0-10, with higher scores indicating worse symptom burden.
次要结局
- Change of Quality of life over time(From baseline to 12 weeks post-CRT)
- Questionnaire response rate(From baseline to 12 weeks post-CRT)
- Trajectory of symptom interference over time based on M. D. Anderson Symptom Inventory-Lung Cancer(From baseline to 12 weeks post-CRT)
研究者
Qian Chu
Professor
Tongji Hospital