Chronic Myeloid Leukemia Clinical Trial
Official title:
Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.
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).
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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