NCT02979678Unknown不适用
The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3
Medical University of Graz9 个研究点 分布在 8 个国家目标入组 260 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 9
- 主要终点
- Quality of life
研究概览
简要总结
The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the development of BR-23 published 1996 the standard therapy of breast cancer has changed. New therapies brought new side effects and different impact on QoL (quality of life) are not sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both from clinical and scientific point of view.
详细描述
- Based on a systematic literature search a new issue list will be developed, containing additional issues relevant for new treatment strategies. A total of 5-10 patients from different countries (5-8) as well as health care professionals (5/country) will be interviewed (Phase 1).
- Operationalization of the issues into items; a provisional version of a the questionnaire and a hypothetic scale structure will be established (Phase2).
- The resulting provisional updated module will be tested with respect to understanding, comprehensiveness and applicability (according to the EORTC Module Development Guidelines). The items will be translated from English into other languages following a standardized forward-backward procedure. Total aof 260 patients will be interviewed from different cultural areas: Northern Europe, Central Europe, Southern Europe, Asia (Phase 3).
- The module and its scale structure will be field-tested in a large, international group of patients in order to determine its acceptability, reliability, validity, responsiveness and crosscultural applicability .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patients with early or metastatic breast cancer
排除标准
- •Patients with second malignancy
结局指标
主要结局
Quality of life
时间窗: 3 years, Patients under treatment are asked once to complete the questionnaire during 3 years
Patients under Treatment are asked to complete the questionnaire
次要结局
未报告次要终点
研究者
研究点 (9)
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