An observational study in Chronic Myeloid Leukemia, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Completed at 14 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational
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.
The development process will follow the international guidelines published by the EORTC Quality of Life Group (QLG). This process will follow three main phases.
Phase 1 of will deal with the review of the literature, identification of an item list and interviews with experts in the treatment of CML and CML patients (undergoing all possible treatments).
In Phase II the identified issues from Phase I will be worded and translated into possible items for the provisional questionnaire using existing EORTC questionnaires and the EORTC QLG Item Bank.
In the Phase III the provisional CML questionnaire will be pre-tested by to a larger sample of CML patients (not the same patients involved in previous phases) and individual structured interviews will be conducted as well. These latter will identify questions that might be irrelevant or whether there will be additional issues not previously included.
Overall up to 480 patients will be enrolled in this study (up to 180 in phase I and up to 300 in phase III).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 480 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (18 years of age or older) with confirmed diagnosis of Philadelphia chromosome positive CML undergoing all possible treatments available.
Exclusion Criteria:
Adult patients (18 years of age or older) with confirmed diagnosis of CML
Other: HRQOL questionnaire
Development of an EORTC questionnaire to assess HRQOL of patients with CML.
Time frame: By the end of the study.
Comparison between physicians' perception of relevance of HRQOL issues with that of patients.
Time frame: By the end of the study.
Development of an EORTC CML symptom checklist.
Time frame: By the end of the study.
HRQOL in CML patients undergoing 2nd line treatment with TKIs.
Time frame: By the end of the study.
Decision making process for choosing between different 2nd line treatments with TKIs.
Time frame: By the end of the study.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Gruppo Italiano Malattie EMatologiche dell'Adulto