Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
研究概览
简要总结
In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.
There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.
The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.
The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.
- •Consent to invitation letter and willing to participate.
排除标准
- •Treatment without curative intent.
- •No consent to invitation letter
结局指标
主要结局
The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
时间窗: One assessment approximately 10 years after radiotherapy
As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain \[Barnett et al, 2012\].
次要结局
- The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.(One assessment approximately 10 years after radiotherapy)
