Care organization and quality of life for people with chronic myeloid leukemia in the Lombardy hematology network
Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network
This project will see if the way hematology centers are organized affects quality of life for adults with chronic myeloid leukemia in Lombardy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT07165535 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with CML who are followed at participating hematology outpatient clinics within the 21 REL centers in Lombardy to compare quality of life across different care models. Participants complete standardized patient-reported outcome tools (EORTC QLQ-C30 and CML24) and provide opinions about aspects of the quality of care they receive. Data on the organizational characteristics of each hematology center will be linked to patient-reported outcomes to explore associations. The study is led by the University of Milano-Bicocca with clinical activity based at Fondazione IRCCS San Gerardo dei Tintori in Monza.
Who should consider this trial
Good fit: Adults (≥18 years) diagnosed with CML who receive care at one of the 21 REL hematology centers in Lombardy and have been followed at the reference hematology center for at least six months are ideal candidates.
Not a fit: People who are not treated at the participating Lombardy centers, have been followed for less than six months, or do not consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify organizational practices that improve quality of life for people living with CML and guide service changes.
How similar studies have performed: Previous observational research has linked care organization to quality of life in oncology and validated CML-specific QoL instruments exist, but multicenter work specifically comparing organizational models in CML is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Monza, MB
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.