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NCT Number: NCT07165535

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

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.

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Key information

Conditions

Chronic Myeloid Leukemia (CML) Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

Location status: Recruiting

Location contact

Carlo Gambacorti-Passerini

CONTACT

[email protected]

+39 0392339553

Carlo Gambacorti-Passerini

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 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.

  2. Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-CML24)

    Time frame: 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.

Secondary outcomes

  1. 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.

    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.

  2. Evaluation of Strengths and Weaknesses of Different Outpatient Organizational Settings

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

    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.

  3. Evaluation of Factors Affecting Daily Life in CML Patients

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

    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.

  4. Evaluation of Emotional Well-being in CML Patients

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

    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.

  5. Impact of CML on Family and Work Relationships

    Time frame: One-time measurement at baseline during the 12-month enrollment period

    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.

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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