跳至主要内容
临床试验/NCT02839863
NCT02839863招募中不适用

Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort

UMC Utrecht4 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
10,000
试验地点
4
主要终点
Change from baseline Quality of Life at 10 years

研究概览

简要总结

Due to better treatment options and earlier detection, survival rates of patients with breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life and the cosmetic outcome are becoming more important. Also, many competing experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are being developed, all in need to be properly evaluated before being implemented in routine clinical care. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard.

By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the investigators aim to:

  • provide an infrastructure for efficient, fast and pragmatic evaluation and implementation of experimental interventions
  • gain insight into short and long-term treatment response, toxicity, complications, quality of life and survival of patients with breast cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patients with breast cancer who undergo irradiation in the UMC Utrecht
  • Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.

排除标准

  • Inability to understand the Dutch language

结局指标

主要结局

Change from baseline Quality of Life at 10 years

时间窗: 10 years

Assesment of Health-related quality of life in breast cancer patients undergoing radiation

次要结局

未报告次要终点

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena M Verkooijen

Associate Professor

UMC Utrecht

研究点 (4)

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