Patient Reported Outcomes in Chronic Myeloid Leukemia
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.|
- Development of an EORTC questionnaire to assess HRQOL of patients with CML. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Comparison between physicians' perception of relevance of HRQOL issues with that of patients. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Development of an EORTC CML symptom checklist. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- HRQOL in CML patients undergoing 2nd line treatment with TKIs. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Decision making process for choosing between different 2nd line treatments with TKIs. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Adults with CML
Adult patients (18 years of age or older) with confirmed diagnosis of CML
|Other: HRQOL questionnaire|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252589
|United States, Massachusetts|
|Dana-Farber Cancer Institute Harvard University|
|Boston, Massachusetts, United States|
|Innsbruck University Hospital|
|University of Ghent|
|Centre Hospitalier Universitaire of Poitiers|
|University of Heidelberg|
|University of Athens|
|University of Baghdad|
|Policlinico S. Orsola - Malpighi, Università di Bologna|
|Ematologia Ospedale "Binaghi", Cagliari|
|Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST|
|Ospedale S.Maria delle Croci|
|Ematologia - Sapienza Università di Roma|
|National Taiwan University|
|Principal Investigator:||Fabio Efficace, PhD||GIMEMA DATA CENTER, ROME, ITALY|