Chronic Myeloid Leukemia
Conditions
Keywords
Chronic myeloid leukemia; quality of life
Brief summary
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.
Interventions
None listed
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Above 18 years of age. * Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML). * Written informed consent. * Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.
Exclusion criteria
* Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires. * Patients who are unable to speak and read the language of the questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML. | 18 months from enrollment |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24). | 18 months from enrollment |
Countries
Austria, Brazil, China, Germany, Iraq, Italy, Malaysia, Netherlands, United States
Outcome results
None listed