Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL

NCT04053933 | Completed DMC

• 1 other identifier: B300201938708
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Myelodysplastic Syndromes

Keywords

QUALMS; MDS; Be-QUALMS; Quality of life; QoL

Outcome Measures

Primary Outcomes (2)

• Change in QUALMS-score

  Change in quality of life-score after the start of a new MDS related treatment

  6 months

• Change in IPQ-score

  Change of ilness perception score after the start of a new MDS related treatment

  6 months

Study Arms (7)

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

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

Patients suffering from myelodysplastic syndromes

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients refusing to sign informed consent

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (21)

Imelda

Bonheiden, Antwerpen, 2820, Belgium

Location

AZ KLINA

Brasschaat, Antwerpen, 2930, Belgium

Location

Sint-Dimpna Ziekenhuis Geel

Geel, Antwerpen, 2240, Belgium

Location

Heilig Hart Ziekenhuis

Lier, Antwerpen, 2500, Belgium

Location

UZA

Edegem, Antwerp, 2650, Belgium

Location

CH Jolimont

La Louvière, Henegouwen, 7100, Belgium

Location

CHR Mons Hainaut

Mons, Henegouwen, 7000, Belgium

Location

CHU Ambroise Paré

Mons, Henegouwen, 7000, Belgium

Location

CHU - UCL Namur site Godinne

Yvoir, Namur, 5530, Belgium

Location

UZ Gent

Ghent, Oost Vlaanderen, 9000, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Oost Vlaanderen, 9100, Belgium

Location

Institute Jules Bordet

Brussels, Vlaams Brabant, 1000, Belgium

Location

UZ Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, Vlaams Brabant, 3000, Belgium

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Vlaams Brabant, 1200, Belgium

Location

AZ Sint Jan Brugge

Bruges, West Vlaanderen, 8000, Belgium

Location

AZ Damiaan Oostende

Ostend, West Vlaanderen, 8400, Belgium

Location

Ziekenhuis Netwerk Antwerpen

Antwerp, 2020, Belgium

Location

GasthuisZusters Antwerpen

Antwerp, 2610, Belgium

Location

CHR Namur

Namur, 5000, Belgium

Location

BR Clinic Saint Pierre Ottignies

Ottignies-Louvain-la-Neuve, Belgium

Location

Related Publications (1)

• Heyrman B, Meers S, De Becker A, Wouters K, Van Hoof A, Van De Velde A, Graux C, Mazure D, Selleslag D, Maes H, Lemmens J, Beckers M, Breems D, Sid S, Berneman Z, Anguille S. Disease Perception Is Correlated with Health-Related Quality of Life in Patients Suffering from Myelodysplastic Syndromes: Results of the Belgian Be-QUALMS Study. Cancers (Basel). 2023 Jun 22;15(13):3296. doi: 10.3390/cancers15133296.

  PMID: 37444406 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zwi Berneman, MD,PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (21)