Spots Global Cancer Trial Database for Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
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Trial Identification
Brief Title: Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
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.
Study ID: NCT00896129
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Nuovo ospedale "Torrette", Ancona, , Italy
Unità Operativa Ematologica - Università degli Studi di Bari, Bari, , Italy
Ospedali Riuniti, Bergamo, , Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli, Bologna, , Italy
Sezione di Ematologia e Trapianti Spedali Civili, Brescia, , Italy
Azienda ASL di Cagliari, Cagliari, , Italy
Ospedale Ferrarotto, Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, , Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna, Ferrara, , Italy
Clinica Ematologica - Università degli Studi, Genova, , Italy
Ematologia 1 - Centro Trapianto di Midollo, Milano, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli", Napoli, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II", Napoli, , Italy
Ospedale S. Luigi Gonzaga, Orbassano, , Italy
Ospedale Cervello, Palermo, , Italy
Azienda ASL di Pescara, Pescara, , Italy
Università di Pisa, Azienda Ospedaliera Pisana, Pisa, , Italy
Ospedale S.Maria delle Croci, Ravenna, , Italy
Ospedali Riuniti - Div. di Ematologia, Reggio Calabria, , Italy
Università La Sapienza, Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma, , Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia, Sassari, , Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese, Siena, , Italy
Azienda USL 9 Treviso - U.O. di Ematologia, Treviso, , Italy
Policlinico G.B. Rossi, Verona, , Italy
Contact Details
Name: Fabio Efficace, PhD
Affiliation: GIMEMA Foundation
Role: STUDY_CHAIR
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