Validation of the Myeloma Patient Outcome Scale (MyPOS) Assessing the Quality of Life in Patients With Multiple Myeloma in the German Speaking Part of Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS)
研究概览
简要总结
In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to German. This translated version will be quantitatively and qualitatively validated with patients with multiple myeloma.
详细描述
Patients with multiple myeloma (N=10) will be interviewed in the qualitative phase about their comprehension of the translated MyPOS. The questionnaire will be revised according to the results of the interviews. This culturally adapted Swiss-German MyPOS will be assessed in the quantitative phase for its' psychometric properties with 200 patients with multiple myeloma.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •informed consent as documented by signature
- •confirmed histological diagnosis of multiple myeloma,
- •age ≥ 18 years,
- •mental capacity to give written informed consent
排除标准
- •inability to communicate in German
- •participation in another clinical study
- •more than one cancer diagnosis
- •mental illness (i.e. psychiatric diagnosis)
结局指标
主要结局
Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS)
时间窗: upon enrollment
The primary outcome will be the scores on each item of the culturally-adapted Swiss-German MyPOS. Items are scored on a five-point Likert scale. For the analysis, the three subscales "Symptoms" (range: 0-52), "Emotions" (range:0-68) and "Healthcare Support" (range: 0-12) are assessed as well as the MyPOS total score (range: 0-132 ) by summing up the item scores ranging from 0-4. Higher scores reflect worse quality of life. The scores will be used to evaluate the psychometric properties of the culturally-adapted Swiss-German MyPOS: * Structural validity, * Internal consistency, * Construct validity, * Convergent and divergent validity.
次要结局
未报告次要终点
研究者
Prof. Dr. med. Julia Dratva
Head of health sciences research unit
Zurich University of Applied Sciences