LIVELUNG - Impact of CGA on QoL, Overall Survival and the Need for Admission in Patients Diagnosed With Localized NSCLC Treated With SBRT - a National Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Quality of Life (EQ-5D)
研究概览
简要总结
Older patients with non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) often die from other causes than lung cancer due to age-related comorbidities. This national randomized study will include 130 patients throughout 5 Danish cancer centres and investigate if a comprehensive geriatric intervention (CGA) when added upfront to SBRT for patients with localized NSCLC will have an impact on quality of life (QoL), overall survival, physical functionality and unplanned hospital admissions.
If an upfront CGA improves patients' general health status, this study could lead to implementation of a CGA in standard clinical practice as well as further research on older patients receiving radiotherapy.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cytologically or histologically proven non-small cell lung cancer
- •Stage T1-3N0M0
- •≥ 70 years old
- •In a multidisciplinary setting the patient is considered medically inoperable, too frail for operation due to age and/or comorbidity or that the patient refuse surgery and therefore candidate for SBRT.
排除标准
- •Missing histology/cytology
- •Another current malignancy
- •Higher staging at treatment planning
- •Not able to provide informed consent
- •Do not speak or understand Danish
结局指标
主要结局
Quality of Life (EQ-5D)
时间窗: 12 months
Questionnaire with 5 dimensions each with 5 (1-5) levels representing the health status of the patient and the patients self-rated health status on a scale from 0-100 (EQ VAS). The score of the 5 dimensions can be converted into a single index value 0-1 with higher values indicating poorer health status.
次要结局
- Hand-grip strength(12 months)
- Quality of Life (EQ-5D)(9 months)
- Unplanned Admissions(12 months)
- Timed-up-and-go (TUG)(12 months)
- Overall Survival (OS)(12 months)
- Chair-stand-test (CST)(12 months)
研究者
Kristian Kirkelund Bentsen
Dr.med.
Odense University Hospital