Clinical trial NCT03075969: Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
Official title: An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukemia; quality of life
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 18 months from enrollment
Secondary outcomes:
measure: 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).
timeFrame: 18 months from enrollment
Other outcomes:
Locations:
city: Emory
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Paranã
country: Brazil
facility: Complexo Hospital de Clinicas da Universidade Federal do Parana
city: Guangdong
country: China
facility: Guangdong Medical University
city: Heidelberg
country: Germany
facility: Universität Heidelberg
city: Baghdad
country: Iraq
facility: Baghdad Teaching Hospital
city: Ancona
country: Italy
facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Consorziale
city: Bologna
country: Italy
facility: Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna
city: Brescia
country: Italy
facility: Sezione di Ematologia e Trapianti Spedali Civili
city: Cagliari
country: Italy
facility: CTMO - Ematologia - Ospedale Binaghi
city: Catania
country: Italy
facility: Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
city: Genova
country: Italy
facility: Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST
city: Lecce
country: Italy
facility: Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
city: Milano
country: Italy
facility: U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano
city: Novara
country: Italy
facility: Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
city: Parma
country: Italy
facility: U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma
city: Pavia
country: Italy
facility: Div. di Ematologia IRCCS Policlinico S. Matteo
city: Piacenza
country: Italy
facility: Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
city: Ravenna
country: Italy
facility: Dipartimento Oncologico - Ospedale S.Maria delle Croci
city: Reggio Emilia
country: Italy
facility: Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
city: Roma
country: Italy
facility: Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"
city: Roma
country: Italy
facility: Divisione di Ematologia - Ospedale S.Eugenio
city: Roma
country: Italy
facility: Divisione Ematologia - Università Campus Bio-Medico
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
city: San Giovanni Rotondo
country: Italy
facility: U.O. di Ematologia - Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: Ematologia - AOU Sassari
city: Verona
country: Italy
facility: U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Kuala Lumpur
country: Malaysia
facility: UCSI University, Faculty of Pharmaceutical Sciences
city: Eindhoven
country: Netherlands
facility: Eindhoven and Tilburg University
Study officials:
affiliation: GIMEMA Foundation
name: Fabio Efficace, PhD
role: STUDY_CHAIR
References: