An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer - Phase III
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Questionnaire
研究概览
简要总结
The goal of this observational study is to pre-test the EORTC QLQ-OV39 to identify and resolve potential problems in its administration and to identify missing/redundant items. A preliminary evaluation of the measurement properties of the module will be carried out.
The study includes patients with evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV) above the age of 18 years.
The main aims are:
- To conduct Phase 3a and 3b pre-testing of the preliminary EORTC-QLQ-OV39 Questionnaire to identify and resolve potential problems in its administration and to identify missing/redundant items according to the updated EORTC QLG Guidelines for Module Development, 5th Edition 2021.(16)
- a preliminary assessment of the psychometric properties of the module
Participants will [describe the main tasks participants will be asked to, complete the OV39, C30 and debriefing interviews, as well as questions about their demographics and clinical data.
详细描述
Follows.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV)
- •Must be able and willing to complete the questionnaires.
- •Must be able to understand and speak the language in which the patient will complete the questionnaire.
- •Age > 18 years
排除标准
- •cognitive impairment
结局指标
主要结局
Questionnaire
时间窗: Last week or last four weeks
Questionnaire for the quality of life of ovarian cancer patients
次要结局
未报告次要终点
研究者
Vesna Bjelic-Radisic
Prof. Dr. Vesna Bjelic-Radisic, Gynaecologist, Director of the Breast Center
Helios University Hospital Wuppertal