Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- NCT03075969
- Brief Summary
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 337
- Above 18 years of age.
- Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
- Written informed consent.
- Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.
- Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.
- Patients who are unable to speak and read the language of the questionnaire.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML. 18 months from enrollment
- Secondary Outcome Measures
Name Time Method The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24). 18 months from enrollment
Trial Locations
- Locations (32)
Innsbruck Medical University
🇦🇹Innsbruck, Austria
Winship Cancer Institute of Emory University
🇺🇸Emory, Georgia, United States
Guangdong Medical University
🇨🇳Guangdong, China
Universität Heidelberg
🇩🇪Heidelberg, Germany
Baghdad Teaching Hospital
🇮🇶Baghdad, Iraq
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
🇮🇹Ancona, Italy
Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale
🇮🇹Bari, Italy
Sezione di Ematologia e Trapianti Spedali Civili
🇮🇹Brescia, Italy
CTMO - Ematologia - Ospedale Binaghi
🇮🇹Cagliari, Italy
Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
🇮🇹Piacenza, Italy
Divisione di Ematologia - Ospedale S.Eugenio
🇮🇹Roma, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
U.O. di Ematologia - Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Ospedale San Bortolo
🇮🇹Vicenza, Italy
Divisione Ematologia - Università Campus Bio-Medico
🇮🇹Roma, Italy
U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano
🇮🇹Milano, Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
🇮🇹Ravenna, Italy
Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
🇮🇹Catania, Italy
Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST
🇮🇹Genova, Italy
Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
🇮🇹Lecce, Italy
Complexo Hospital de Clinicas da Universidade Federal do Parana
🇧🇷Paranã, Brazil
UCSI University, Faculty of Pharmaceutical Sciences
🇲🇾Kuala Lumpur, Malaysia
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
🇮🇹Roma, Italy
Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"
🇮🇹Novara, Italy
Ematologia - AOU Sassari
🇮🇹Sassari, Italy
U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma
🇮🇹Parma, Italy
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"
🇮🇹Roma, Italy
Eindhoven and Tilburg University
🇳🇱Eindhoven, Netherlands