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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Unknown status

CT.gov ID

NCT03075969

Collaborator

(none)

337

Enrollment

Locations

27.9

Anticipated Duration (Months)

10.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Chronic Myeloid Leukemia

Study Design

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 :

Aug 3, 2017

Actual Primary Completion Date :

Mar 16, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Winship Cancer Institute of Emory University	Emory	Georgia	United States	30322
2	Innsbruck Medical University	Innsbruck		Austria
3	Complexo Hospital de Clinicas da Universidade Federal do Parana	Paranã		Brazil
4	Guangdong Medical University	Guangdong		China
5	Universität Heidelberg	Heidelberg		Germany
6	Baghdad Teaching Hospital	Baghdad		Iraq
7	Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi	Ancona		Italy
8	Azienda Ospedaliero-Universitaria Policlinico Consorziale	Bari		Italy
9	Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna	Bologna		Italy
10	Sezione di Ematologia e Trapianti Spedali Civili	Brescia		Italy	21125
11	CTMO - Ematologia - Ospedale Binaghi	Cagliari		Italy
12	Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto	Catania		Italy
13	Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST	Genova		Italy
14	Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE	Lecce		Italy
15	U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano	Milano		Italy
16	Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"	Novara		Italy
17	Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone	Palermo		Italy
18	U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma	Parma		Italy
19	Div. di Ematologia IRCCS Policlinico S. Matteo	Pavia		Italy	27100
20	Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto	Piacenza		Italy
21	Dipartimento Oncologico - Ospedale S.Maria delle Croci	Ravenna		Italy
22	Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova	Reggio Emilia		Italy
23	Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"	Roma		Italy
24	Divisione di Ematologia - Ospedale S.Eugenio	Roma		Italy
25	Divisione Ematologia - Università Campus Bio-Medico	Roma		Italy
26	Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Roma		Italy
27	U.O. di Ematologia - Casa Sollievo della Sofferenza	San Giovanni Rotondo		Italy
28	Ematologia - AOU Sassari	Sassari		Italy
29	U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona	Verona		Italy
30	Ospedale San Bortolo	Vicenza		Italy	36100
31	UCSI University, Faculty of Pharmaceutical Sciences	Kuala Lumpur		Malaysia
32	Eindhoven and Tilburg University	Eindhoven		Netherlands

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Study Chair: Fabio Efficace, PhD, GIMEMA Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT03075969

Other Study ID Numbers:

QoL-CML 0916

First Posted:

Mar 9, 2017

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto

Chronic myeloid leukemia; quality of life

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Mar 21, 2019