Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network

NCT07165535 | Recruiting

• 1 other identifier: CML-OPERAP
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Myeloid Leukemia (CML)

Outcome Measures

Primary Outcomes (2)

• Quality 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.

  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.

  One-time measurement at baseline during the 12-month enrollment period.

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with Chronic Myeloid Leukemia.

You may qualify if:

• 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.

You may not qualify if:

• Subjects who have not given consent to participate in the study.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 10, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): May 17, 2026
• Study Completion (Estimated): May 17, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

IT (1)