Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 20
- 主要终点
- General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
研究概览
简要总结
The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Man with a histologically proven prostate cancer
- •Indication of a curative intent radiotherapy
- •Age ≥ 75 years
- •Patient who signed an informed consent
排除标准
- •Patient with metastatic prostate cancer
- •Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
- •A person who is not affiliated to a social security scheme or of such a scheme
- •Patient under trusteeship
研究组 & 干预措施
geriatric assessment and quality of life
Included patient must have a geriatric assessment before radiotherapy and 6 months later.
Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later.
干预措施: geriatric assessment and quality of life (Other)
geriatric assessment and quality of life
Included patient must have a geriatric assessment before radiotherapy and 6 months later.
Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
时间窗: 6 months
Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months. Tolerance will be called correct in other cases. This threshold of 20 points was selected according to the work of Osoba.
Complete geriatric assessment
时间窗: 6 months
This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .
次要结局
未报告次要终点