Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- the 6-month autonomy after surgery
研究概览
简要总结
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.
We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male or female aged 70 years old or more
- •Patient with a resectable cancer( thoracic, digestive ore urologic);
- •Patients who have to undergo a surgery with general anaesthesia;
- •Patients treated in one of the partner programme unit ;
- •Patient able to fill in an auto-questionnaire alone or with some help;
- •Patient who have signed an informed consent and who commits himself or herself to respect the protocol instructions.
排除标准
- •Patient younger than 70 years old;
- •Patient who is not registered to the social ;
- •Patient for whom surgery is performed under local anaesthesia;
- •Patient unable to fill-in alone an autoquestionnaire (because of an inability to read French language or severe cognitive troubles);
- •Patient treated with neuroleptic or lithium ;
- •Patient with already known cognitive impairment (Alzheimer, dementia, neurologic sequel);
- •Patient under legal protection;
- •Patient who has not signed informed consent.
结局指标
主要结局
the 6-month autonomy after surgery
时间窗: 24 MONTHS
次要结局
- 12-month autonomy(48 months)
