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

• Conditions: Adult; Myelodysplastic Syndromes

• Registration Number: NCT00809575
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study Start: 2008-10-02
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2018-10-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 927

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.	After 5 years from study entry.

Secondary Outcome Measures

Name	Time	Method
To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.	After 5 years from study entry.
To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes.	After 5 years from study entry.
To evaluate accuracy of clinical prediction of survival.	After 5 years from study entry.
To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy.	After 5 years from study entry.
To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes.	After 5 years from study entry.	i.e. overall survival, AML transformation, toxicity and response to therapy.
To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.	After 5 years from study entry.
To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics.	After 5 years from study entry.
To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories.	After 5 years from study entry.
To devise a prognostic patient-based index.	After 5 years from study entry.

Trial Locations

Locations (53)

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

AZ Sint-Jan AV, Department of Hematology; 🇧🇪 Brugge, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, 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

Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka; 🇭🇷 Rijeka, Croatia

General Teaching Hospital; 🇨🇿 Prague, Czechia

Kunming Medical University; 🇨🇳 Kunming, China

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

ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo; 🇮🇹 Cagliari, Italy

Unità Operativa Ematologia 1 - Università degli Studi di Bari; 🇮🇹 Bari, Italy

CTMO - Ematologia - Ospedale "Binaghi"; 🇮🇹 Cagliari, Italy

Ospedale "Ferrarotto"; 🇮🇹 Catania, Italy

A.O. Pugliese Ciaccio; 🇮🇹 Catanzaro, Italy

Aou Careggi - Firenze - Sod Ematologia; 🇮🇹 Firenze, Italy

Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""; 🇮🇹 Genova, Italy

Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione; 🇮🇹 Cona, 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

Ospedale S. Luigi Gonzaga; 🇮🇹 Orbassano, 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

Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo; 🇮🇹 Parma, Italy

Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti; 🇮🇹 Piacenza, Italy

Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Italy

Università degli Studi - Policlinico di Tor Vergata; 🇮🇹 Roma, Italy

Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia; 🇮🇹 Reggio Emilia, Italy

Divisione Ematologia - Università Campus Bio-Medico; 🇮🇹 Roma, Italy

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli; 🇮🇹 Roma, Italy

Complesso Ospedaliero S. Giovanni Addolorata; 🇮🇹 Roma, Italy

Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia; 🇮🇹 Roma, Italy

SOS Dipartimento di Oncoematologia Osp. Rovigo; 🇮🇹 Rovigo, Italy

U.O.C. Ematologia - Ospedale S.Eugenio; 🇮🇹 Rome, Italy

Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette; 🇮🇹 Torino, Italy

Ematologia - Dipartimento di Medicina Clinica e Sperimentale; 🇮🇹 Sassari, Italy

National Taiwan University; 🇨🇳 Taipei, Taiwan

Bradford Institute of Health Research; 🇬🇧 Bradford, United Kingdom

London North West Healthcare NHS Trust; 🇬🇧 London, United Kingdom

St James's University Hospital; 🇬🇧 Leeds, United Kingdom

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; 🇨🇳 China, China