跳至主要内容
临床试验/NCT02000011
NCT02000011已完成不适用

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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年5月23日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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