NCT04053933

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2019-08-13
• Last updated: 2025-03-30

Locations

21 sites across 1 country: Belgium