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NCT03075969 Clinical Trial

Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia

Chronic Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03075969
Other study ID # QoL-CML 0916
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 3, 2017
Est. completion date December 2019

Study information
Verified date March 2019
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 337
Est. completion date December 2019
Est. primary completion date March 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Innsbruck Medical University Innsbruck
Brazil Complexo Hospital de Clinicas da Universidade Federal do Parana Paranã
China Guangdong Medical University Guangdong
Germany Universität Heidelberg Heidelberg
Iraq Baghdad Teaching Hospital Baghdad
Italy Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Ancona
Italy Azienda Ospedaliero-Universitaria Policlinico Consorziale Bari
Italy Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna Bologna
Italy Sezione di Ematologia e Trapianti Spedali Civili Brescia
Italy CTMO - Ematologia - Ospedale Binaghi Cagliari
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 U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano Milano
Italy Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato" Novara
Italy Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone Palermo
Italy U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma Parma
Italy Div. di Ematologia IRCCS Policlinico S. Matteo Pavia
Italy Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto Piacenza
Italy Dipartimento Oncologico - Ospedale S.Maria delle Croci Ravenna
Italy Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Reggio Emilia
Italy Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza" Roma
Italy Divisione di Ematologia - Ospedale S.Eugenio Roma
Italy Divisione Ematologia - Università Campus Bio-Medico Roma
Italy Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Roma
Italy U.O. di Ematologia - Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy Ematologia - AOU Sassari Sassari
Italy U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona Verona
Italy Ospedale San Bortolo Vicenza
Malaysia UCSI University, Faculty of Pharmaceutical Sciences Kuala Lumpur
Netherlands Eindhoven and Tilburg University Eindhoven
United States Winship Cancer Institute of Emory University Emory Georgia

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  China,  Germany,  Iraq,  Italy,  Malaysia,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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