Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study
试验速览
- 阶段
- 不适用
- 入组人数
- 927
- 试验地点
- 53
- 主要终点
- To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.
研究概览
简要总结
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.
PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.
详细描述
This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.
时间窗: After 5 years from study entry.
次要结局
- To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.(After 5 years from study entry.)
- To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes.(After 5 years from study entry.)
- To evaluate accuracy of clinical prediction of survival.(After 5 years from study entry.)
- To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy.(After 5 years from study entry.)
- To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes.(After 5 years from study entry.)
- To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.(After 5 years from study entry.)
- To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics.(After 5 years from study entry.)
- To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories.(After 5 years from study entry.)
- To devise a prognostic patient-based index.(After 5 years from study entry.)