跳至主要内容
临床试验/CTRI/2021/07/034792
CTRI/2021/07/034792进行中(未招募)不适用

PROspecTive Study on the use of gEriatriC assessment Tools for validation of 1- year mortality in non-metastatic breast cancer patients 65 years and older

Tata Memorial Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年7月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
Cumulative incidence of 1 year mortality.

研究概览

简要总结

The proposed study focuses on assessing the older patients (>/= 65 years) by using three geriatric scales. The aim of the study is to detect various problems faced by the older patients undergoing treatment for breast cancer. These include health related, social, psychological and economic problems. The four scales which will be used are Multidimensional prognostic index and Onco-multidimensional prognostic index, both of which involves a detailed assessment, VES-13 and G8 which are shorter tools. This assessment will be carried out at the beginning of the cancer directed treatment so that we can understand how treatment decisions (and subsequent survival) are affected by various factors in elderly patients. The quality of life will also be assessed using WHO-BREF questionnaire, which will be given at the time of initial assessment, after the completion of treatment and also during follow up every 6 months till 2 years. The   survival outcome and quality of life will be studied in relation to the geriatric scales data. Moreover, the usefulness of the short tools (G8 and VES-13) will be studied with respect to the longer MPI & onco-MPI tool to understand feasibility for routine clinical use. The study will be conducted over a 4-year period, 2 years for accrual of 300 patients and 2 years for follow up.

研究设计

研究类型
Observational

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • a study of geriatric breast cancer patients.

排除标准

  • 1.Not willing to participate 2.Unable to understand the questionnaires.

结局指标

主要结局

Cumulative incidence of 1 year mortality.

时间窗: 1 year

次要结局

  • 1.Validation of MPI and Onco-MPI for 1-year mortality.(2.Comparison of outcome using MPI and Onco-MPI with conventional prognostic factors.)

研究者

发起方
Tata Memorial Center
申办方类型
Research institution and hospital

研究点 (1)

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