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

NCT ID: NCT03075969

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-03

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Efficace, PhD

Role: STUDY_CHAIR

GIMEMA Foundation

Locations

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Winship Cancer Institute of Emory University

Emory, Georgia, United States

Site Status

Innsbruck Medical University

Innsbruck, , Austria

Site Status

Complexo Hospital de Clinicas da Universidade Federal do Parana

Paranã, , Brazil

Site Status

Guangdong Medical University

Guangdong, , China

Site Status

Universität Heidelberg

Heidelberg, , Germany

Site Status

Baghdad Teaching Hospital

Baghdad, , Iraq

Site Status

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

Ancona, , Italy

Site Status

Azienda Ospedaliero-Universitaria Policlinico Consorziale

Bari, , Italy

Site Status

Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna

Bologna, , Italy

Site Status

Sezione di Ematologia e Trapianti Spedali Civili

Brescia, , Italy

Site Status

CTMO - Ematologia - Ospedale Binaghi

Cagliari, , Italy

Site Status

Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

Catania, , Italy

Site Status

Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST

Genova, , Italy

Site Status

Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Lecce, , Italy

Site Status

U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano

Milan, , Italy

Site Status

Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"

Novara, , Italy

Site Status

Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone

Palermo, , Italy

Site Status

U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma

Parma, , Italy

Site Status

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, , Italy

Site Status

Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto

Piacenza, , Italy

Site Status

Dipartimento Oncologico - Ospedale S.Maria delle Croci

Ravenna, , Italy

Site Status

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, , Italy

Site Status

Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"

Roma, , Italy

Site Status

Divisione di Ematologia - Ospedale S.Eugenio

Roma, , Italy

Site Status

Divisione Ematologia - Università Campus Bio-Medico

Roma, , Italy

Site Status

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

Site Status

U.O. di Ematologia - Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Ematologia - AOU Sassari

Sassari, , Italy

Site Status

U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status

Ospedale San Bortolo

Vicenza, , Italy

Site Status

UCSI University, Faculty of Pharmaceutical Sciences

Kuala Lumpur, , Malaysia

Site Status

Eindhoven and Tilburg University

Eindhoven, , Netherlands

Site Status

Countries

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United States Austria Brazil China Germany Iraq Italy Malaysia Netherlands

Other Identifiers

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QoL-CML 0916

Identifier Type: -

Identifier Source: org_study_id

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