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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings