Clinical trial · Observational
Patient Reported Outcomes in Chronic Myeloid Leukemia
Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison. The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose. The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRQOL questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults with CML
- description
- Adult patients (18 years of age or older) with confirmed diagnosis of CML
- interventionNames
- Other: HRQOL questionnaire
Primary outcomes (1)
- measure
- Development of an EORTC questionnaire to assess HRQOL of patients with CML.
- timeFrame
- By the end of the study.
Secondary outcomes (4)
- measure
- Comparison between physicians' perception of relevance of HRQOL issues with that of patients.
- timeFrame
- By the end of the study.
- measure
- Development of an EORTC CML symptom checklist.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18 years of age or older) * Confirmed diagnosis of Philadelphia chromosome positive CML * Informed consent provided * Patients enrolled in investigational treatment trials are eligible * Ability to speak and read language of the Questionnaire Exclusion Criteria: * Freedom from overt cognitive impairment or major psychiatric conditions that may confound HRQOL evaluation
References
Publications (1)
- BACKGROUNDEfficace F, Baccarani M, Breccia M, Saussele S, Abel G, Caocci G, Guilhot F, Cocks K, Naeem A, Sprangers M, Oerlemans S, Chie W, Castagnetti F, Bombaci F, Sharf G, Cardoni A, Noens L, Pallua S, Salvucci M, Nicolatou-Galitis O, Rosti G, Mandelli F. International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res. 2014 Apr;23(3):825-36. doi: 10.1007/s11136-013-0523-5. Epub 2013 Sep 13. PMID 24026634