Recruiting NCT07165535
Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Myeloid Leukemia (CML). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-C30) [Time frame: One-time measurement at baseline during the 12-month enrollment period]
- Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-CML24) [Time frame: One-time measurement at baseline during the 12-month enrollment period.]
Secondary outcome measures (5)
- Evaluation of Different Organizational and Care Models of Hematology Outpatient Clinics for CML Patients [Time frame: One-time measurement at baseline during the 12-month enrollment period.]
- Evaluation of Strengths and Weaknesses of Different Outpatient Organizational Settings [Time frame: One-time measurement at baseline during the 12-month enrollment period.]
- Evaluation of Factors Affecting Daily Life in CML Patients [Time frame: One-time measurement at baseline during the 12-month enrollment period.]
- Evaluation of Emotional Well-being in CML Patients [Time frame: One-time measurement at baseline during the 12-month enrollment period.]
- Impact of CML on Family and Work Relationships [Time frame: One-time measurement at baseline during the 12-month enrollment period]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Subjects who have not given consent to participate in the study.
- Subjects who do not meet the inclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS San Gerardo dei Tintori — Monza
Identifiers
NCT: NCT07165535 · CML-OPERAP