Financial Effects of a Tumor Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Validation of FIAT questionnaire (pre-version): Distribution analysis
研究概览
简要总结
This study aims to develop and to validate a standardised German-language instrument for measuring experienced financial effects of a cancer diagnosis and therapy in a cross-sectional bi-centre study. Obtained data will make the patient-related description of financial difficulties more comprehensible, communicable and addressable in the future, e.g. by offering targeted advisory aids or considering financial effects in health technology assessments.
详细描述
Methods and analysis:
Phase 1: Construct definition and item generation
Preliminary study:
The preliminary study aims to identify dimensions, topics and risk factors that are relevant for the assessment of financial effects through qualitative interviews with patients, focus group discussions with potential users of a new instrument (social services, HTA-institutions, payers) and a systematic literature review.
Preliminary questionnaire:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Any type of historically or cytological confirmed solid cancer or haematological malignancy with an ECOG-Status <2 and at least two month of cancer related therapy
- •Patients are treated at the day care unit or ambulances of the NCT Heidelberg or oncological ward B100 at Jena University Hospital
排除标准
- •Patients younger than 18 years old
- •Patients who refuse or withdraw from informed consent
- •No sufficient level of German language
结局指标
主要结局
Validation of FIAT questionnaire (pre-version): Distribution analysis
时间窗: 4 months
Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)
Validation of FIAT questionnaire (pre-version): Factorial validity
时间窗: 4 months
Exploratory Factor Analysis (EFA) will be used to analyse the factorial structure of the instrument to investigate which theoretically defined properties of the construct can adequately covered and differentiated with help of single indicators (items and questions).
Validation of FIAT questionnaire (final version): Distribution analysis
时间窗: 5 months
Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)
Validation of FIAT questionnaire (final version): Factorial validity
时间窗: 5 months
Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used.
Validation of FIAT questionnaire (pre-version): Reliability
时间窗: 4 months
Preliminary assessment of reliability with Guttmans-Lambda
Validation of FIAT questionnaire (pre-version and final version): Test-retest-reliability
时间窗: 5 months
Correlations between the measurements between the first and second survey will be obtained to evaluate test-retest-reliability.
Validation of FIAT questionnaire (final version): Test-fairness
时间窗: 5 months
Test fairness will be evaluated by means of Multi-Group Confirmatory Factor Analysis (MG-CFA).
次要结局
未报告次要终点
研究者
Eva Winkler, MD
Prof. Dr. Dr.
University Hospital Heidelberg