Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL
- Conditions
- Myelodysplastic Syndromes
- Registration Number
- NCT04053933
- Lead Sponsor
- University Hospital, Antwerp
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in QUALMS-score 6 months Change in quality of life-score after the start of a new MDS related treatment
Change in IPQ-score 6 months Change of ilness perception score after the start of a new MDS related treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Imelda
🇧🇪Bonheiden, Antwerpen, Belgium
AZ KLINA
🇧🇪Brasschaat, Antwerpen, Belgium
Sint-Dimpna Ziekenhuis Geel
🇧🇪Geel, Antwerpen, Belgium
Heilig Hart Ziekenhuis
🇧🇪Lier, Antwerpen, Belgium
UZA
🇧🇪Edegem, Antwerp, Belgium
CH Jolimont
🇧🇪La Louvière, Henegouwen, Belgium
CHR Mons Hainaut
🇧🇪Mons, Henegouwen, Belgium
CHU Ambroise Paré
🇧🇪Mons, Henegouwen, Belgium
CHU - UCL Namur site Godinne
🇧🇪Yvoir, Namur, Belgium
UZ Gent
🇧🇪Gent, Oost Vlaanderen, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Oost Vlaanderen, Belgium
Institute Jules Bordet
🇧🇪Brussel, Vlaams Brabant, Belgium
UZ Brussel
🇧🇪Jette, Vlaams Brabant, Belgium
UZ Leuven Gasthuisberg
🇧🇪Leuven, Vlaams Brabant, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Woluwe-Saint-Lambert, Vlaams Brabant, Belgium
AZ Sint Jan Brugge
🇧🇪Brugge, West Vlaanderen, Belgium
AZ Damiaan Oostende
🇧🇪Oostende, West Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen
🇧🇪Antwerpen, Belgium
GasthuisZusters Antwerpen
🇧🇪Antwerpen, Belgium
CHR Namur
🇧🇪Namur, Belgium
BR Clinic Saint Pierre Ottignies
🇧🇪Ottignies-Louvain-la-Neuve, Belgium