Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL (Be-QUALMS)

August 9, 2019 updated by: Zwi Berneman, University Hospital, Antwerp

A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.

Study type An observational study conducted in different hematological centers in Belgium.

Study objectives

Primary objective:

To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes.

Secondary objectives:

  • To assess the impact of newly started therapy on disease perception in MDS patients
  • To study the relation between disease perception and quality of life
  • To examine which clinical and disease specific factors determine QOL in MDS patients
  • Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life.
  • To evaluate whether changes in QOL are related to hematological respons.

Study design

  • Newly diagnosed MDS patients who are about to start a treatment or previously diagnosed MDS patients who are starting with a new line of therapy.
  • QOL assessment with the QUALMS.
  • Disease perception measurement using the B-IPQ.
  • Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment.

Study endpoints

Primary endpoint:

Change in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment.

Secondary endpoint:

  • Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment
  • Association between B-IPQ and QUALMS score.
  • Association between clinical and disease specific factors and QUALMS score
  • Association between transfusion threshold and QUALMS score.
  • Association between hematological response and QUALMS score

Summary of eligibility criteria

  • Adult patients with a new diagnosis of MDS (according to WHO 2016 definitions (3) or known patients with MDS who are about to start a new treatment.
  • Signed informed consent.
  • Patients enrolled in an unblinded interventional therapeutic trial are eligible.

Exclusion criteria

  • Patients with acute leukemia defined as >20% bone marrow blasts.
  • Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease.
  • Patients in post allogeneic transplant setting.
  • Patients enrolled in a blinded interventional therapeutic trial.
  • Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy.
  • Newly diagnosed patients who do not start with treatment.
  • Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed).
  • Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.
  • Patients refusing to sign informed consent.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

350

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

  • Belgium
      • Antwerpen, Belgium, 2020
        • Recruiting
        • Ziekenhuis Netwerk Antwerpen
        • Contact:
        • Principal Investigator:
          • Bert Heyrman
      • Antwerpen, Belgium, 2610
        • Recruiting
        • GasthuisZusters Antwerpen
        • Contact:
        • Principal Investigator:
          • Jan Lemmens
      • Namur, Belgium, 5000
        • Recruiting
        • CHR Namur
        • Contact:
        • Principal Investigator:
          • Jasmine Nguyen
      • Ottignies-Louvain-la-Neuve, Belgium
        • Recruiting
        • BR Clinic Saint Pierre Ottignies
        • Principal Investigator:
          • Thierry Connerotte
        • Contact:
          • Isabella Vanbellinghen
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
      • Brasschaat, Antwerpen, Belgium, 2930
      • Geel, Antwerpen, Belgium, 2240
      • Lier, Antwerpen, Belgium, 2500
        • Recruiting
        • Heilig Hart Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Ann Van De Velde
    • Henegouwen
      • La Louvière, Henegouwen, Belgium, 7100
        • Recruiting
        • CH Jolimont
        • Contact:
          • Petre Hélène
        • Contact:
          • helene.petre@jolimont.be
        • Principal Investigator:
          • Selim Sid
      • Mons, Henegouwen, Belgium, 7000
      • Mons, Henegouwen, Belgium, 7000
    • Namur
      • Yvoir, Namur, Belgium, 5530
    • Oost Vlaanderen
      • Gent, Oost Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
        • Principal Investigator:
          • Domoniek Mazure
      • Sint-Niklaas, Oost Vlaanderen, Belgium, 9100
    • Vlaams Brabant
      • Brussel, Vlaams Brabant, Belgium, 1000
        • Recruiting
        • Institute Jules Bordet
        • Contact:
          • Anne De Meuter
        • Principal Investigator:
          • Sebastian Wittnebel
      • Jette, Vlaams Brabant, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Contact:
          • Natalie Hoedemaekers
        • Principal Investigator:
          • Ann De Becker
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven Gasthuisberg
        • Contact:
        • Principal Investigator:
          • Marielle Beckers
      • Woluwe-Saint-Lambert, Vlaams Brabant, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Principal Investigator:
          • Marie-Christiane Vekemans
        • Contact:
    • West Vlaanderen
      • Brugge, West Vlaanderen, Belgium, 8000
        • Recruiting
        • AZ Sint Jan Brugge
        • Principal Investigator:
          • Dominik Selleslag
        • Contact:
      • Oostende, West Vlaanderen, Belgium, 8400
        • Recruiting
        • AZ Damiaan Oostende
        • Contact:
        • Principal Investigator:
          • Achiel Van Hoof

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from myelodysplastic syndromes

Description

Inclusion Criteria:

  • Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.
  • Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.
  • Signed informed consent

Exclusion criteria

  • Patients with acute leukemia defined as >20% bone marrow blasts.
  • Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this case the disease has both dysplastic and proliferative features but cannot be properly categorized to either group. This category includes chronic myelomonocytic leukemia (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.
  • Patients in post allogeneic transplant setting.
  • Patients enrolled in a blinded interventional therapeutic trial.
  • Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.
  • Newly diagnosed patients who do not start with treatment.
  • Patients who started a previous MDS related treatment less then 4 weeks ago.
  • Patients who started a previous MDS related treatment less then 12 weeks ago apart from packed cell transfusions.
  • Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.
  • Patients refusing to sign informed consent

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients treated with ESA
Patients treated with 5'azacitidin
Patients treated with deferoxamine
Patients treated with deferasirox
Patients treated with transfusion only
Patients treated with lenalidomide
Patients treated with intensive chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QUALMS-score
Time Frame: 6 months
Change in quality of life-score after the start of a new MDS related treatment
6 months
Change in IPQ-score
Time Frame: 6 months
Change of ilness perception score after the start of a new MDS related treatment
6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Zwi Berneman, MD,PhD, University Hospital, Antwerp

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)

August 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201938708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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