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Brief Title: Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes
Official Title: Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study
Study ID: NCT00809575
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Memorial Sloan-Kettering Cancer Center (MSKCC), New York, New York, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, 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, Italy
U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea, Ivrea, Torino, 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, , 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, , Italy
Divisione di Ematologia Ospedale "Santa Maria Goretti", Latina, , Italy
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia, Lecce, , 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, , Italy
Ospedale Niguarda "Ca Granda", Milano, , 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, , 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, , 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, , Italy
Università degli Studi - Policlinico di Tor Vergata, Roma, , Italy
Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia, Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma, , Italy
Complesso Ospedaliero S. Giovanni Addolorata, Roma, , Italy
U.O.C. Ematologia - Ospedale S.Eugenio, Rome, , Italy
SOS Dipartimento di Oncoematologia Osp. Rovigo, Rovigo, , 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
Name: Fabio Efficace, PhD
Affiliation: Gruppo Italiano Malattie EMatologiche dell'Adulto
Role: PRINCIPAL_INVESTIGATOR