NCT03096496Unknown不适用
Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 161
- 试验地点
- 16
- 主要终点
- To examine cross-sectional long-term differences in health outcomes after treatment end.
研究概览
简要总结
This is a prospective and international observational study run by the GIMEMA. All data will be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients reported outcomes will be collected using internationally validated questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •APL survivors enrolled in GIMEMA APL0406 clinical trial and in first molecular CR after third consolidation treatment
- •Written informed consent.
排除标准
- •APL patients previously enrolled in GIMEMA APL0406 trial who cannot be reached or who are lost to follow-up.
结局指标
主要结局
To examine cross-sectional long-term differences in health outcomes after treatment end.
时间窗: Two years after study entry.
Indicated by selected key-QoL outcomes (i.e. Fatigue, Cognitive and Role functioning scales from the EORTC-QLQ-C30 questionnaire), between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.
次要结局
- To compare the long-term QoL profile, after treatment end, of APL patients treated with ATRA- chemotherapy and ATRA-ATO with that of their peers in the general population.(Two years after study entry.)
- To examine long-term differences in health outcomes after treatment end indicated by all QoL outcomes not considered in primary objectives, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.(Two years after study entry.)
- To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end.(Two years after study entry.)
- To assess and compare the cumulative incidence and types of physician-reported late adverse effects (e.g. cardiac function) and secondary cancer, between randomized treatment groups.(Two years after study entry.)
- To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups.(Two years after study entry.)
研究者
研究点 (16)
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