Follow-up in Early and Locally Advanced Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 830
- 试验地点
- 33
- 主要终点
- Health-related quality of life
研究概览
简要总结
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.
详细描述
The objective of this study is to assess follow-up patterns and identify patients with increased levels of physical and/or psychosocial problems after treatment in early breast cancer and locally advanced breast cancer.
830 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.
Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 139 Quality of Life questions, at one single time point.
Statistical analysis includes descriptive statistic for socio-demographic and clinical data, overall and per treatment, age and risk group. Patterns of follow-up will be identified and described overall, and per treatment, age, risk group and country.
Where available, normative data will be used to identify those QoL domains where there is a clinically relevant difference with the general population.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven Early Breast Cancer (EBC) and Locally Advanced Breast Cancer (LABC) patients who have completed their primary treatment (except endocrine therapy), between 12 months and 36 months after the diagnosis.
- •Disease-free without any evidence of relapse
- •Age ≥ 18 years.
- •Ability to understand and fill out questionnaires.
- •Written informed consent.
排除标准
- •Metastatic breast cancer (defined as secondary spread to other organs, such as bones, lung, liver, mediastinal lymph nodes) or DCIS.
- •Other cancer diagnosis in the past 5 years except non-melanotic skin cancer or cervical intraepithelial neoplasia.
- •Male breast cancer.
- •Patients on maintenance therapy (other than endocrine therapy).
- •Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
- •Any psychological (including preexisting psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
结局指标
主要结局
Health-related quality of life
时间窗: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
次要结局
未报告次要终点