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

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.