Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
Rationale: At present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-HRQOL) of CML patients treated with Imatinib.
Purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||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.|
- 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. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Psychological wellbeing. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Fatigue. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Adherence to therapy issues. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Symptom burden. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Possible association between socio-demographic and clinical variables with patient reported health outcomes. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896129
|Nuovo ospedale "Torrette"|
|Unità Operativa Ematologica - Università degli Studi di Bari|
|Bari, Italy, 70124|
|Ist.Ematologia e Oncologia Medica L.e A. Seragnoli|
|Sezione di Ematologia e Trapianti Spedali Civili|
|Brescia, Italy, 21125|
|Azienda ASL di Cagliari|
|Cagliari, Italy, 9121|
|Catania, Italy, 95124|
|Azienda Ospedaliera Pugliese Ciaccio|
|Catanzaro, Italy, 88100|
|Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna|
|Ferrara, Italy, 44100|
|Clinica Ematologica - Università degli Studi|
|Ematologia 1 - Centro Trapianto di Midollo|
|Milano, Italy, 20122|
|Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II"|
|Napoli, Italy, 80131|
|Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"|
|Napoli, Italy, 80131|
|Ospedale S. Luigi Gonzaga|
|Orbassano, Italy, 10043|
|Palermo, Italy, 90146|
|Azienda ASL di Pescara|
|Pescara, Italy, 61100|
|Università di Pisa, Azienda Ospedaliera Pisana|
|Pisa, Italy, 72100|
|Ospedale S.Maria delle Croci|
|Ravenna, Italy, 48100|
|Ospedali Riuniti - Div. di Ematologia|
|Reggio Calabria, Italy, 85100|
|Università Cattolica del Sacro Cuore - Policlinico A. Gemelli|
|Università La Sapienza|
|Roma, Italy, 00100|
|Serv. di Ematologia Ist. di Ematologia ed Endocrinologia|
|U.O. Ematologia, Azienda Ospedaliera Universitaria Senese|
|Siena, Italy, 53100|
|Azienda USL 9 Treviso - U.O. di Ematologia|
|Treviso, Italy, 31100|
|Policlinico G.B. Rossi|
|Verona, Italy, 37134|
|Study Chair:||Fabio Efficace, PhD||GIMEMA Foundation|