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

NCT00809575 | Unknown

• 3 other identifiers: QOL-MDS0108GIMEMA-QOL-MDS-0108EU-20885
• Study Type: observational
• Target: 927
• Locations: 12 countries
• Sites: 53

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.

Conditions

Adult; Myelodysplastic Syndromes

Keywords

adult; de novo myelodysplastic syndromes; Quality of life; Patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes.

  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 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 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 establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.

  After 5 years from study entry.

Interventions

questionnaire administration OTHER

fatigue assessment and management OTHER

observation OTHER

quality-of-life assessment OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with myelodysplastic syndromes (MDS).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (53)

Memorial Sloan-Kettering Cancer Center (MSKCC)

New York, New York, 10065, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Innsbruck University Hospital

Innsbruck, Austria

Location

ZNA Middelheim

Antwerp, Belgium

Location

AZ Sint-Jan AV, Department of Hematology

Bruges, Belgium

Location

CH Jolimont

Brussels, Belgium

Location

CHC - Centre Hospitalier Chrétien

Liège, Belgium

Location

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

Location

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

China, China

Location

Kunming Medical University

Kunming, China

Location

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

Rijeka, Croatia

Location

General Teaching Hospital

Prague, Czechia

Location

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

Saint-Cloud, France

Location

Purpan Hospital - Internal Medicine Department

Toulouse, France

Location

Department of Hematology - Universitatsklinikum Carl Gustav Carus

Dresden, Germany

Location

University of Freiburg Medical Center

Freiburg im Breisgau, Germany

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

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

Ivrea, Torino, 10015, Italy

Location

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

Asti, Italy

Location

Unità Operativa Ematologia 1 - Università degli Studi di Bari

Bari, 70010, Italy

Location

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

Cagliari, Italy

Location

CTMO - Ematologia - Ospedale "Binaghi"

Cagliari, Italy

Location

Ospedale "Ferrarotto"

Catania, Italy

Location

A.O. Pugliese Ciaccio

Catanzaro, Italy

Location

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

Cona, Italy

Location

Aou Careggi - Firenze - Sod Ematologia

Florence, Italy

Location

Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""

Genova, 16132, Italy

Location

Divisione di Ematologia Ospedale "Santa Maria Goretti"

Latina, Italy

Location

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

Lecce, 73100, Italy

Location

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

Meldola, Italy

Location

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

Milan, 20132, Italy

Location

Ospedale Niguarda "Ca Granda"

Milan, 20162, Italy

Location

UO Ematologia - AOU Policlinico di Modena

Modena, Italy

Location

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

Monza, Italy

Location

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

Novara, 28100, Italy

Location

Ospedale S. Luigi Gonzaga

Orbassano, Italy

Location

Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo

Parma, Italy

Location

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

Pavia, 27100, Italy

Location

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

Piacenza, Italy

Location

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

Reggio Emilia, Italy

Location

Divisione Ematologia - Università Campus Bio-Medico

Roma, 00128, Italy

Location

Università degli Studi - Policlinico di Tor Vergata

Roma, 00133, Italy

Location

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

Roma, 00161, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, 00168, Italy

Location

Complesso Ospedaliero S. Giovanni Addolorata

Roma, 00184, Italy

Location

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

Rome, Italy

Location

SOS Dipartimento di Oncoematologia Osp. Rovigo

Rovigo, 45100, Italy

Location

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, Italy

Location

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

Torino, Italy

Location

National Taiwan University

Taipei, Taiwan

Location

Bradford Institute of Health Research

Bradford, United Kingdom

Location

St James's University Hospital

Leeds, United Kingdom

Location

London North West Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 24478321 BACKGROUND

• 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.

  PMID: 26120100 BACKGROUND

• 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.

  PMID: 25272332 BACKGROUND

• 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.

  PMID: 26404501 BACKGROUND

• 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.

  PMID: 29231969 BACKGROUND

• 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.

  PMID: 32086447 BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Therapeutics; Observation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Fabio Efficace, PhD

  Gruppo Italiano Malattie EMatologiche dell'Adulto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: October 2, 2008
• Primary Completion: October 8, 2018
• Study Completion: February 1, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

AU (1); US (2); DE (2); GB (3); BE (4); BR (1); CN (2); CR (1); CZ (1); IT (33); FR (2); TW (1)