Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients With Complete Cytogenetic Response Treated With Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.
OBJECTIVES:
Primary: to investigate a number of mid to long-term HRQOL issues in Chronic Myeloid
Leukemia (CML) patients with complete cytogenetic response treated with Imatinib as First
Line Therapy.
Secondary evaluation of:
- Psychological wellbeing.
- Fatigue.
- Adherence to therapy issues.
- Symptom burden.
- Possible association between social-demographic and clinical variables with patient
reported health outcomes.
OUTLINE:This is a multicenter study.
SAMPLE SIZE:
Sample size estimation has not been performed considering the nature of the study and the
lack of preliminary data to hypothesize the number of possible eligible patients in each
center.
DURATION OF THE STUDY:
The recruitment period is estimated in approximately 6 to 12 months.
Observational
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Italy: Ethics Committee
QOL-CML0208
NCT00896129
March 2009
December 2009
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