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

NCT ID: NCT00809575

Last Updated: 2020-12-22

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

927 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-02

Study Completion Date

2021-02-28

Brief Summary

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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

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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.

Conditions

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Adult Myelodysplastic Syndromes

Keywords

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adult de novo myelodysplastic syndromes Quality of life Patient reported outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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questionnaire administration

Intervention Type OTHER

fatigue assessment and management

Intervention Type OTHER

observation

Intervention Type OTHER

quality-of-life assessment

Intervention Type OTHER

Eligibility Criteria

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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.
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: PRINCIPAL_INVESTIGATOR

Gruppo Italiano Malattie EMatologiche dell'Adulto

Locations

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Memorial Sloan-Kettering Cancer Center (MSKCC)

New York, New York, United States

Site Status

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Innsbruck University Hospital

Innsbruck, , Austria

Site Status

ZNA Middelheim

Antwerp, , Belgium

Site Status

AZ Sint-Jan AV, Department of Hematology

Bruges, , Belgium

Site Status

CH Jolimont

Brussels, , Belgium

Site Status

CHC - Centre Hospitalier Chrétien

Liège, , Belgium

Site Status

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

Site Status

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

China, , China

Site Status

Kunming Medical University

Kunming, , China

Site Status

Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka

Rijeka, , Croatia

Site Status

General Teaching Hospital

Prague, , Czechia

Site Status

Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie

Saint-Cloud, , France

Site Status

Purpan Hospital - Internal Medicine Department

Toulouse, , France

Site Status

Department of Hematology - Universitatsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

University of Freiburg Medical Center

Freiburg im Breisgau, , Germany

Site Status

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Site Status

U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea

Ivrea, Torino, Italy

Site Status

Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia

Asti, , Italy

Site Status

Unità Operativa Ematologia 1 - Università degli Studi di Bari

Bari, , Italy

Site Status

ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo

Cagliari, , Italy

Site Status

CTMO - Ematologia - Ospedale "Binaghi"

Cagliari, , Italy

Site Status

Ospedale "Ferrarotto"

Catania, , Italy

Site Status

A.O. Pugliese Ciaccio

Catanzaro, , Italy

Site Status

Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione

Cona, , Italy

Site Status

Aou Careggi - Firenze - Sod Ematologia

Florence, , Italy

Site Status

Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""

Genova, , Italy

Site Status

Divisione di Ematologia Ospedale "Santa Maria Goretti"

Latina, , Italy

Site Status

ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia

Lecce, , Italy

Site Status

Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

Meldola, , Italy

Site Status

U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele

Milan, , Italy

Site Status

Ospedale Niguarda "Ca Granda"

Milan, , Italy

Site Status

UO Ematologia - AOU Policlinico di Modena

Modena, , Italy

Site Status

Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta

Monza, , Italy

Site Status

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Site Status

Ospedale S. Luigi Gonzaga

Orbassano, , Italy

Site Status

Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo

Parma, , Italy

Site Status

Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo

Pavia, , Italy

Site Status

Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

Piacenza, , Italy

Site Status

Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia

Reggio Emilia, , Italy

Site Status

Divisione Ematologia - Università Campus Bio-Medico

Roma, , Italy

Site Status

Università degli Studi - Policlinico di Tor Vergata

Roma, , Italy

Site Status

Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, , Italy

Site Status

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

Site Status

Complesso Ospedaliero S. Giovanni Addolorata

Roma, , Italy

Site Status

U.O.C. Ematologia - Ospedale S.Eugenio

Rome, , Italy

Site Status

SOS Dipartimento di Oncoematologia Osp. Rovigo

Rovigo, , Italy

Site Status

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, , Italy

Site Status

Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette

Torino, , Italy

Site Status

National Taiwan University

Taipei, , Taiwan

Site Status

Bradford Institute of Health Research

Bradford, , United Kingdom

Site Status

St James's University Hospital

Leeds, , United Kingdom

Site Status

London North West Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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Australia India Netherlands South Africa United States Austria Belgium Brazil China Croatia Czechia France Germany Italy Taiwan United Kingdom

References

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Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F. Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes. Ann Oncol. 2014 Feb;25(2):447-54. doi: 10.1093/annonc/mdt557.

Reference Type BACKGROUND
PMID: 24478321 (View on PubMed)

Caocci G, Voso MT, Angelucci E, Stauder R, Cottone F, Abel G, Nguyen K, Platzbecker U, Beyne-Rauzy O, Gaidano G, Invernizzi R, Molica S, Criscuolo M, Breccia M, Lubbert M, Sanpaolo G, Buccisano F, Ricco A, Palumbo GA, Niscola P, Zhang H, Fenu S, La Nasa G, Mandelli F, Efficace F. Accuracy of physician assessment of treatment preferences and health status in elderly patients with higher-risk myelodysplastic syndromes. Leuk Res. 2015 Aug;39(8):859-65. doi: 10.1016/j.leukres.2015.05.012. Epub 2015 Jun 12.

Reference Type BACKGROUND
PMID: 26120100 (View on PubMed)

Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, Bowen D, Lubbert M, Angelucci E, Stauder R, Selleslag D, Platzbecker U, Sanpaolo G, Jonasova A, Buccisano F, Specchia G, Palumbo GA, Niscola P, Wan C, Zhang H, Fenu S, Klimek V, Beyne-Rauzy O, Nguyen K, Mandelli F. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015 Feb;168(3):361-70. doi: 10.1111/bjh.13138. Epub 2014 Oct 1.

Reference Type BACKGROUND
PMID: 25272332 (View on PubMed)

Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015 Nov;16(15):1506-1514. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21.

Reference Type BACKGROUND
PMID: 26404501 (View on PubMed)

Efficace F, Cottone F, Abel G, Niscola P, Gaidano G, Bonnetain F, Anota A, Caocci G, Cronin A, Fianchi L, Breccia M, Stauder R, Platzbecker U, Palumbo GA, Luppi M, Invernizzi R, Bergamaschi M, Borin L, Di Tucci AA, Zhang H, Sprangers M, Vignetti M, Mandelli F. Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes. Cancer. 2018 Mar 15;124(6):1251-1259. doi: 10.1002/cncr.31193. Epub 2017 Dec 12.

Reference Type BACKGROUND
PMID: 29231969 (View on PubMed)

Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia. 2020 Sep;34(9):2451-2459. doi: 10.1038/s41375-020-0746-8. Epub 2020 Feb 21.

Reference Type BACKGROUND
PMID: 32086447 (View on PubMed)

Other Identifiers

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GIMEMA-QOL-MDS-0108

Identifier Type: -

Identifier Source: secondary_id

EU-20885

Identifier Type: -

Identifier Source: secondary_id

QOL-MDS0108

Identifier Type: -

Identifier Source: org_study_id

NCT00872768

Identifier Type: -

Identifier Source: nct_alias