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

December 21, 2020 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

927

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck University Hospital
  • Belgium
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Brugge, Belgium
        • AZ Sint-Jan AV, Department of Hematology
      • Bruxelles, Belgium
        • CH Jolimont
      • Liege, Belgium
        • CHC - Centre Hospitalier Chrétien
  • Brazil
      • Curitiba, Brazil
        • Curitiba Unidade de Hematologia - Hemoterapia e Oncologia. Setor de Transplante de Medula Ossea. Complexo Hospital de Clinicas da Universidade Federal do Parana (CHC-UFPR)
  • China
      • China, China
        • Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
      • Kunming, China
        • Kunming Medical University
  • Croatia
      • Rijeka, Croatia
        • Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka
  • Czechia
      • Prague, Czechia
        • General Teaching Hospital
  • France
      • Saint-Cloud, France
        • Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie
      • Toulouse, France
        • Purpan Hospital - Internal Medicine Department
  • Germany
      • Dresden, Germany
        • Department of Hematology - Universitatsklinikum Carl Gustav Carus
      • Freiburg, Germany
        • University of Freiburg Medical Center
  • Italy
      • Asti, Italy
        • Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
      • Bari, Italy, 70010
        • Unità Operativa Ematologia 1 - Università degli Studi di Bari
      • Cagliari, Italy
        • ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo
      • Cagliari, Italy
        • CTMO - Ematologia - Ospedale "Binaghi"
      • Catania, Italy
        • Ospedale "Ferrarotto"
      • Catanzaro, Italy
        • A.O. Pugliese Ciaccio
      • Cona, Italy
        • Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione
      • Firenze, Italy
        • Aou Careggi - Firenze - Sod Ematologia
      • Genova, Italy, 16132
        • Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""
      • Latina, Italy
        • Divisione di Ematologia Ospedale "Santa Maria Goretti"
      • Lecce, Italy, 73100
        • ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
      • Meldola, Italy
        • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
      • Milano, Italy, 20132
        • U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
      • Milano, Italy, 20162
        • Ospedale Niguarda "Ca Granda"
      • Modena, Italy
        • UO Ematologia - AOU Policlinico di Modena
      • Monza, Italy
        • Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta
      • Novara, Italy, 28100
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Orbassano, Italy
        • Ospedale S. Luigi Gonzaga
      • Parma, Italy
        • Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
      • Pavia, Italy, 27100
        • Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
      • Piacenza, Italy
        • Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
      • Reggio Emilia, Italy
        • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia
      • Roma, Italy, 00184
        • Complesso Ospedaliero S. Giovanni Addolorata
      • Roma, Italy, 00168
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy, 00128
        • Divisione Ematologia - Università Campus Bio-Medico
      • Roma, Italy, 00133
        • Università degli Studi - Policlinico di Tor Vergata
      • Roma, Italy, 00161
        • Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Rome, Italy
        • U.O.C. Ematologia - Ospedale S.Eugenio
      • Rovigo, Italy, 45100
        • SOS Dipartimento di Oncoematologia Osp. Rovigo
      • Sassari, Italy
        • Ematologia - Dipartimento di Medicina Clinica e Sperimentale
      • Torino, Italy
        • Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
    • Torino
      • Ivrea, Torino, Italy, 10015
        • U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University
  • United Kingdom
      • Bradford, United Kingdom
        • Bradford Institute of Health Research
      • Leeds, United Kingdom
        • St James's University Hospital
      • London, United Kingdom
        • London North West Healthcare NHS Trust
  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center (MSKCC)
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas, MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with myelodysplastic syndromes (MDS).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
After 5 years from study entry.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: After 5 years from study entry.
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.
Time Frame: After 5 years from study entry.
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.
Time Frame: After 5 years from study entry.
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.
Time Frame: After 5 years from study entry.
After 5 years from study entry.
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.
After 5 years from study entry.
To devise a prognostic patient-based index.
Time Frame: After 5 years from study entry.
After 5 years from study entry.
To evaluate accuracy of clinical prediction of survival.
Time Frame: After 5 years from study entry.
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.
Time Frame: After 5 years from study entry.
After 5 years from study entry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Fabio Efficace, PhD, Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2008

Primary Completion (ACTUAL)

October 8, 2018

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (ESTIMATE)

December 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QOL-MDS0108
  • GIMEMA-QOL-MDS-0108
  • EU-20885

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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