跳至主要内容
临床试验/NCT03059875
NCT03059875进行中(未招募)不适用

Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)

Poitiers University Hospital9 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2014年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
79
试验地点
9
主要终点
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery

研究概览

简要总结

The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.

Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.

The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • First breast cancer localized, indication of surgery
  • Onco-geriatric filter (FOG) >= 1 ou < 4

排除标准

  • Male, less of 75 years old
  • Contraindication of surgery
  • Breast cancer with metastasis
  • Onco-geriatric filter (FOG) = 0 or 4

结局指标

主要结局

Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery

时间窗: 5 years

次要结局

  • Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery(5 years)
  • Patient satisfaction with their management(5 years)
  • Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard(5 years)
  • Quality of life of patients(5 years)
  • Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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