NCT03755856Unknown不适用
A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 343
- 试验地点
- 39
- 主要终点
- Number of differences in SF-36 scores
研究概览
简要总结
This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20% blasts in the bone marrow), except acute promyelocytic leukemia (APL).
- •Age at AML diagnosis ≥ 18 years,
- •Date of AML diagnosis at least 5 years before study enrollment,
- •AML-free status at study enrollment,
- •Written informed consent provided.
排除标准
- •Major cognitive deficit or psychiatric problems hampering a self-reported evaluation,
- •Not speaking and reading the language of the participating country,
- •More than 75 years at the time of study enrollment,
- •Receiving any active treatment for AML at the time of study enrollment.
结局指标
主要结局
Number of differences in SF-36 scores
时间窗: At enrollment
The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population.
次要结局
- Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.(At enrollment)
- Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.(At enrollment)
- Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.(At enrollment)
- QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.(At enrollment)
研究者
研究点 (39)
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