NCT04378855进行中（未招募）不适用
Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 572
- 试验地点
- 25
- 主要终点
- Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
研究概览
简要总结
This study will ultimately aim at developing a GIMEMA platform for collecting HRQoL and symptom burden information on Italian patients with Philadelphia chromosome negative MPN. The main objective of the protocol is to improve our understanding of the impact of the disease and various treatments on patients-wellbeing, symptom burden and daily functioning.
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
- •Patients diagnosed with Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (pre-PMF, overt-PMF) and post-ET/post-PV Myelofibrosis (MF), (i.e. Philadelphia chromosome negative myeloproliferative neoplasm (MPN)) according to 2016 WHO classification.
- •Known IPSS/IPSET/DIPSS risk score category at time of initial diagnosis of PV, ET and PMF, respectively.
- •Initial diagnosis of MPN within one year before date of registration.
- •Having a full baseline PRO Evaluation completed.
- •Adult patients (≥ 18 years old).
- •Written informed consent provided.
排除标准
- •Having any kind of psychiatric disorder or major cognitive dysfunction problems hampering a self-reported evaluation.
- •Not able to read and understand local language (i.e. Italian).
结局指标
主要结局
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
时间窗: After 5 years from study entry
To detect a baseline difference of at least 4 points between MPN patients and their peers in the general population in any of the following primary scales of the EORTC QLQ-C30 questionnaire: fatigue, global QoL/health status, physical, emotional and role functioning (all ranging from 0 to 100 points).
次要结局
- Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population(After 5 years from study entry)
- MPN patients' baseline profiles of self-reported HRQoL(After 5 years from study entry)
- Prognostic value of baseline patients' self-reported fatigue(After 5 years from study entry)
- Prognostic value of baseline patients' self-reported HRQoL(After 5 years from study entry)
- Relationship between pruritus and HRQoL.(After 5 years from study entry)
- Patterns over time of HRQoL(After 5 years from study entry)
- Prognostic patient-based index(After 5 years from study entry)
- Physicians' and patients' preferences for involvement in treatment decision-making(After 5 years from study entry)
- Relationship between self-reported satisfaction with care with other HRQoL outcomes.(After 5 years from study entry)
研究者
研究点 (25)
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