Myelodysplastic Syndrome Clinical Trial

Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes

Summary

RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.

PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.

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Full Description

This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria

Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration.
Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale).
Adult patients (≥ 18 years old).
Written informed consent provided.

Exclusion criteria

Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
Patients with therapy related MDS.
Having any kind of psychiatric disorder or major cognitive dysfunction.
Not able to read and understand local language.

Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

927

Study ID:

NCT00809575

Recruitment Status:

Active, not recruiting

Sponsor:

Gruppo Italiano Malattie EMatologiche dell'Adulto

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There are 17 Locations for this study

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Memorial Sloan-Kettering Cancer Center (MSKCC)
New York New York, 10065, United States
The University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Innsbruck University Hospital
Innsbruck , , Austria
ZNA Middelheim
Antwerpen , , Belgium
AZ Sint-Jan AV, Department of Hematology
Brugge , , Belgium
CH Jolimont
Bruxelles , , Belgium
CHC - Centre Hospitalier Chrétien
Liege , , Belgium
Curitiba Unidade de Hematologia - Hemoterapia e Oncologia. Setor de Transplante de Medula Ossea. Complexo Hospital de Clinicas da Universidade Federal do Parana (CHC-UFPR)
Curitiba , , Brazil
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
China , , China
Kunming Medical University
Kunming , , China
Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka
Rijeka , , Croatia
General Teaching Hospital
Prague , , Czechia
Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie
Saint-Cloud , , France
Purpan Hospital - Internal Medicine Department
Toulouse , , France
Department of Hematology - Universitatsklinikum Carl Gustav Carus
Dresden , , Germany
University of Freiburg Medical Center
Freiburg , , Germany
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo Foggia, 71013, Italy
U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea
Ivrea Torino, 10015, Italy
Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti , , Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari , 70010, Italy
ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo
Cagliari , , Italy
CTMO - Ematologia - Ospedale "Binaghi"
Cagliari , , Italy
Ospedale "Ferrarotto"
Catania , , Italy
A.O. Pugliese Ciaccio
Catanzaro , , Italy
Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona , , Italy
Aou Careggi - Firenze - Sod Ematologia
Firenze , , Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""
Genova , 16132, Italy
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina , , Italy
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce , 73100, Italy
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
Meldola , , Italy
U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
Milano , 20132, Italy
Ospedale Niguarda "Ca Granda"
Milano , 20162, Italy
UO Ematologia - AOU Policlinico di Modena
Modena , , Italy
Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta
Monza , , Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara , 28100, Italy
Ospedale S. Luigi Gonzaga
Orbassano , , Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma , , Italy
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
Pavia , 27100, Italy
Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza , , Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia
Reggio Emilia , , Italy
Divisione Ematologia - Università Campus Bio-Medico
Roma , 00128, Italy
Università degli Studi - Policlinico di Tor Vergata
Roma , 00133, Italy
Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma , 00161, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma , 00168, Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma , 00184, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Rome , , Italy
SOS Dipartimento di Oncoematologia Osp. Rovigo
Rovigo , 45100, Italy
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari , , Italy
Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette
Torino , , Italy
National Taiwan University
Taipei , , Taiwan
Bradford Institute of Health Research
Bradford , , United Kingdom
St James's University Hospital
Leeds , , United Kingdom
London North West Healthcare NHS Trust
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

927

Study ID:

NCT00809575

Recruitment Status:

Active, not recruiting

Sponsor:


Gruppo Italiano Malattie EMatologiche dell'Adulto

How clear is this clinincal trial information?

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