跳至主要内容
临床试验/NCT06078319
NCT06078319已完成不适用

Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

IRCCS Azienda Ospedaliero-Universitaria di Bologna28 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2021年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
28
主要终点
Adherence

研究概览

简要总结

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire. Each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.

详细描述

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. These data will be collected at the first administration of the ARMS questionnaire and again after 12, 24, and 48 weeks. If performed, any additional assessments will also be recorded. Each individual patient will be administered the questionnaire (ARMS) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. If in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. The minimum expected duration of individual patient observation is 48 weeks.

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

入选标准

  • Age ≥ 18 years
  • Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia Vera or diagnosed with Polycythemia Vera who are in the treatment with ruxolitinib therapy in accordance with normal clinical practice
  • Obtaining informed consent for data collection and processing
  • The Patient must come to the in-person visit at least once, an occasion on which informed consent to 'study membership will be offered

排除标准

  • 未提供

结局指标

主要结局

Adherence

时间窗: 2 years

Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence

Distress

时间窗: 2 years

Emotional distress is measured based on a visual analogue scale with the distress thermometer, a simple and quick (3-4 minutes) tool that investigates the areas most involved in distress (minimum value: 0, lower distress; maximum value: 10, higher distress)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (28)

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