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Trial record 3 of 3083 for:    "Myeloid Leukemia"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03075969
Recruitment Status : Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease
Chronic Myeloid Leukemia

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Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : March 16, 2019
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  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. [ Time Frame: 18 months from enrollment ]

Secondary Outcome Measures :
  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). [ Time Frame: 18 months from enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075969


Locations
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United States, Georgia
Winship Cancer Institute of Emory University
Emory, Georgia, United States, 30322
Austria
Innsbruck Medical University
Innsbruck, Austria
Brazil
Complexo Hospital de Clinicas da Universidade Federal do Parana
Paranã, Brazil
China
Guangdong Medical University
Guangdong, China
Germany
Universität Heidelberg
Heidelberg, Germany
Iraq
Baghdad Teaching Hospital
Baghdad, Iraq
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, 21125
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, 27100
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, Italy, 36100
Malaysia
UCSI University, Faculty of Pharmaceutical Sciences
Kuala Lumpur, Malaysia
Netherlands
Eindhoven and Tilburg University
Eindhoven, Netherlands
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Fabio Efficace, PhD GIMEMA Foundation

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03075969     History of Changes
Other Study ID Numbers: QoL-CML 0916
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic myeloid leukemia; quality of life

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases