Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort
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
- 否
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
Helena M Verkooijen
Associate Professor
UMC Utrecht
