Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-C30)
研究概览
简要总结
The primary objective of the study is to assess the impact of the organizational model of the hematology center on the quality of life of patients with CML estimated through standardized tools (EORTC QLQ-30, CML24) and through the patient's opinion regarding aspects of the quality of care.
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
- •Subjects aged 18 years or older.
- •Subjects diagnosed with Chronic Myeloid Leukemia.
- •Subjects diagnosed with CML under care at the hematology outpatient clinics of the 21 REL centers.
- •Subjects followed at the reference hematology center for a minimum of 6 months.
- •Freely given informed consent obtained before the start of the study.
排除标准
- •Subjects who have not given consent to participate in the study.
- •Subjects who do not meet the inclusion criteria.
结局指标
主要结局
Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-C30)
时间窗: One-time measurement at baseline during the 12-month enrollment period
Quality of life in CML patients will be assessed using the validated EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). This instrument evaluates multiple domains of physical, emotional, and social functioning, as well as general cancer-related symptoms. The questionnaire consists of 30 items, with 28 items scored from 1 (minimum functioning/symptom presence) to 4 (maximum functioning/symptom presence), and 2 items scored from 1 to 7. Raw scores are transformed according to EORTC guidelines onto a standardized scale from 0 to 100, where 0 represents the lowest functioning or symptom level and 100 represents the highest functioning or symptom level. For functional scales and the global health status, higher scores indicate better quality of life, whereas for symptom scales, higher scores indicate worse quality of life.
Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-CML24)
时间窗: One-time measurement at baseline during the 12-month enrollment period.
Quality of life in CML patients will also be assessed using the validated EORTC QLQ-CML24 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Chronic Myeloid Leukemia 24), which measures symptoms and functioning specifically related to CML. This questionnaire includes 24 items scored from 1 to 4. Raw scores are transformed according to EORTC guidelines onto a standardized 0 to 100 scale, with 0 indicating the lowest and 100 the highest level of functioning or symptom presence. Higher scores on functional scales correspond to better quality of life, while higher scores on symptom scales correspond to worse quality of life.
次要结局
- Evaluation of Different Organizational and Care Models of Hematology Outpatient Clinics for CML Patients(One-time measurement at baseline during the 12-month enrollment period.)
- Evaluation of Strengths and Weaknesses of Different Outpatient Organizational Settings(One-time measurement at baseline during the 12-month enrollment period.)
- Evaluation of Factors Affecting Daily Life in CML Patients(One-time measurement at baseline during the 12-month enrollment period.)
- Evaluation of Emotional Well-being in CML Patients(One-time measurement at baseline during the 12-month enrollment period.)
- Impact of CML on Family and Work Relationships(One-time measurement at baseline during the 12-month enrollment period)