Chronic Myeloid Leukemia (CML)NCT07165535
Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network
An observational study of Chronic Myeloid Leukemia (CML), run by University of Milano Bicocca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2025to 17 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with Chronic Myeloid Leukemia.
Who may be able to join
- 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.
Who cannot join
- Subjects who have not given consent to participate in the study.
- Subjects who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Carlo Gambacorti-Passerini, +39 0392339553, carlo.gambacorti@unimib.it
Carlo Gambacorti-Passerini
About this study
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)
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One-time measurement at baseline during the 12-month enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start17 Apr 2025
- Primary completion17 May 2026 (estimated)
- Study completion17 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165535
- Sponsor's protocol ID
- CML-OPERAP
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network
- ClinicalTrials.gov ID
- NCT07165535
- Acronym / sponsor ID
- CML-OPERAP
- Conditions
- Chronic Myeloid Leukemia (CML)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 17 May 2026 (estimated)
- Study completion
- 17 May 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with Chronic Myeloid Leukemia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects who have not given consent to participate in the study.
- Subjects who do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia (CML), run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Assessed Through Standardized Questionnaires (EORTC QLQ-C30) (time frame: One-time measurement at baseline during the 12-month enrollment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.