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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809575
Recruitment Status : Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : February 26, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Adult Myelodysplastic Syndromes Other: questionnaire administration Other: fatigue assessment and management Other: observation Other: quality-of-life assessment

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.

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Study Type : Observational
Actual Enrollment : 929 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 2, 2008
Actual Primary Completion Date : October 8, 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients. [ Time Frame: After 5 years from study entry. ]

Secondary Outcome Measures :
  1. To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes. [ Time Frame: After 5 years from study entry. ]
    i.e. overall survival, AML transformation, toxicity and response to therapy.

  2. To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy. [ Time Frame: After 5 years from study entry. ]
  3. To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories. [ Time Frame: After 5 years from study entry. ]
  4. To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. [ Time Frame: After 5 years from study entry. ]
  5. To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. [ Time Frame: After 5 years from study entry. ]
  6. To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes. [ Time Frame: After 5 years from study entry. ]
  7. To devise a prognostic patient-based index. [ Time Frame: After 5 years from study entry. ]
  8. To evaluate accuracy of clinical prediction of survival. [ Time Frame: After 5 years from study entry. ]
  9. To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics. [ Time Frame: After 5 years from study entry. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with myelodysplastic syndromes (MDS).

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 6 months before date of registration.
  • Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5DFACIT-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809575

  Hide Study Locations
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United States, California
University of Southern California (USC)
Los Angeles, California, United States, 90007
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York, United States, 10065
United States, Texas
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sir Charles Gairdner Hospital
Nedlands, Australia
Innsbruck University Hospital
Innsbruck, Austria
ZNA Middelheim
Antwerpen, Belgium
AZ Sint-Jan AV, Department of Hematology
Brugge, Belgium
CH Jolimont
Bruxelles, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
CHC - Centre Hospitalier Chrétien
Liege, Belgium
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
China, China
Kunming Medical University
Kunming, China
General Teaching Hospital
Prague, Czechia
Purpan Hospital - Internal Medicine Department
Toulouse, France
Department of Hematology - Universitatsklinikum Carl Gustav Carus
Dresden, Germany
University of Freiburg Medical Center
Freiburg, Germany
Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannattasio - Azienda ASL 3
Rossano, Cosenza, Italy, 87068
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
S. G. Rotondo, Foggia, Italy, 71013
U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea
Ivrea, Torino, Italy, 10015
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy, 70010
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
Brescia, Italy, 25123
ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo
Cagliari, Italy
CTMO - Ematologia - Ospedale "Binaghi"
Cagliari, Italy
A.O. Garibaldi Unità Onco-Ematologia
Catania, Italy, 95126
Ospedale "Ferrarotto"
Catania, Italy
A.O. Pugliese Ciaccio
Catanzaro, Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""
Genova, Italy, 16132
Unità di Ematologia Universitaria - Ospedale - S.Maria Goretti
Latina, Italy, 04100
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina, Italy
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce, Italy, 73100
Centro Aziendale di Ematologia ASL N. 6
Livorno, 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, 20132
Ospedale Niguarda "Ca Granda"
Milano, Italy, 20162
UO Ematologia - AOU Policlinico di Modena
Modena, Italy
Ospedale San Gennaro - ASL Napoli 1
Napoli, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy, 28100
Ospedale S. Luigi Gonzaga
Orbassano, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
Università degli Studi di Palermo - A.U. Policlinico
Palermo, Italy
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy, 65100
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina
Pisa, Italy, 56126
U.O. Oncologia Medica A.S.L. 4 Ospedale Misericordia e Dolce
Prato, Italy, 59100
Ospedale S.Maria delle Croci
Ravenna, Italy
Ospedale "Infermi"
Rimini, Italy
Divisione Ematologia - Università Campus Bio-Medico
Roma, Italy, 00128
Università degli Studi - Policlinico di Tor Vergata
Roma, Italy, 00133
Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy, 00161
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy, 00168
Complesso Ospedaliero S. Giovanni Addolorata
Roma, Italy, 00184
U.O.C. Ematologia - Ospedale S.Eugenio
Rome, Italy
SOS Dipartimento di Oncoematologia Osp. Rovigo
Rovigo, Italy, 45100
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari, Italy
South Africa
Stellenbosch University - Tygerberg Academic Hospital
Cape Town, South Africa
National Taiwan University
Taipei, Taiwan
United Kingdom
Bradford Institute of Health Research
Bradford, United Kingdom
St James's University Hospital
Leeds, United Kingdom
University Hospital
Nottingham, United Kingdom
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Principal Investigator: Fabio Efficace, PhD Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT00809575     History of Changes
Obsolete Identifiers: NCT00872768
Other Study ID Numbers: QOL-MDS0108
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
de novo myelodysplastic syndromes
Quality of life
Patient reported outcomes

Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions