Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 25
- 主要终点
- Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
研究概览
简要总结
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.
Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.
详细描述
OBJECTIVES:
Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
Secondary evaluation of:
- Psychological wellbeing.
- Fatigue.
- Adherence to therapy issues.
- Symptom burden.
- Possible association between social-demographic and clinical variables with patient reported health outcomes.
OUTLINE:This is a multicenter study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age 18 years.
- •CML patients meeting the following criteria:
- •Started IM therapy in the early chronic phase (ECP).
- •Have been undergoing treatment with IM, as first line therapy, for at least three years regardless of the current prescribed dose of IM.
- •In complete cytogenetic response (CCgR) and no clinical evidence of disease progression to accelerated phase (AP) or blast crisis (BC).
- •Able to read and write Italian.
- •Freedom from psychiatric conditions that may confound HRQOL evaluation.
- •Informed consent provided.
排除标准
- •CML patients who were initially diagnosed in the AP or BC or those who started therapy with IM in the late chronic phase (LCP).
- •Having received any kind of treatment prior to IM therapy (except for hydroxyurea and/or anagrelide).
- •Patients with a new primary malignancy.
结局指标
主要结局
Number of mid to long-term HRQOL issues in Chronic Myeloid Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First Line Therapy.
时间窗: By the end of the study.
次要结局
- Psychological wellbeing.(By the end of the study.)
- Fatigue.(By the end of the study.)
- Symptom burden.(By the end of the study.)
- Adherence to therapy issues.(By the end of the study.)
- Possible association between socio-demographic and clinical variables with patient reported health outcomes.(By the end of the study.)