Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
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)
1 other identifier
observational
337
9 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 21, 2019
March 1, 2019
1.6 years
March 6, 2017
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Eligibility Criteria
The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Winship Cancer Institute of Emory University
Emory, Georgia, 30322, United States
Innsbruck Medical University
Innsbruck, Austria
Complexo Hospital de Clinicas da Universidade Federal do Parana
Paranã, Brazil
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
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, 21125, 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
Milan, 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, 27100, 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, 36100, Italy
UCSI University, Faculty of Pharmaceutical Sciences
Kuala Lumpur, Malaysia
Eindhoven and Tilburg University
Eindhoven, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fabio Efficace, PhD
GIMEMA Foundation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2017
First Posted
March 9, 2017
Study Start
August 3, 2017
Primary Completion
March 16, 2019
Study Completion
December 1, 2019
Last Updated
March 21, 2019
Record last verified: 2019-03