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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy
RECRUITINGQuality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-C30)
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.
Time frame: One-time measurement at baseline during the 12-month enrollment period
Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-CML24)
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.
Time frame: One-time measurement at baseline during the 12-month enrollment period.
Evaluation of Different Organizational and Care Models of Hematology Outpatient Clinics for CML Patients
Assessment of how different organizational models of hematology outpatient clinics (e.g., structure, workflow, resource allocation) influence the patient experience and perceived quality of care within the REL network. Data for these outcomes will be collected through study-specific questionnaires administered to patients.
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Time frame: One-time measurement at baseline during the 12-month enrollment period.
Evaluation of Strengths and Weaknesses of Different Outpatient Organizational Settings
Comparison of perceived strengths and weaknesses of various organizational settings, such as large vs. small centers and dedicated outpatient clinics vs. time-slot-based care. Data for these outcomes will be collected through study-specific questionnaires administered to patients.
Time frame: One-time measurement at baseline during the 12-month enrollment period.
Evaluation of Factors Affecting Daily Life in CML Patients
Assessment of the impact of CML and its management on daily living activities, autonomy, and social participation, as reported by patients. Data for these outcomes will be collected through study-specific questionnaires administered to patients.
Time frame: One-time measurement at baseline during the 12-month enrollment period.
Evaluation of Emotional Well-being in CML Patients
Assessment of the emotional and psychological status of patients using validated tools (e.g., emotional functioning domain of EORTC QLQ-C30). Data for these outcomes will be collected through study-specific questionnaires administered to patients.
Time frame: One-time measurement at baseline during the 12-month enrollment period.
Impact of CML on Family and Work Relationships
Evaluation of how CML affects patients' family dynamics and work life, including ability to work, interpersonal relationships, and role functioning. Data for these outcomes will be collected through study-specific questionnaires administered to patients.
Time frame: One-time measurement at baseline during the 12-month enrollment period