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.