Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL — Be-QUALMS  

Myelodysplastic Syndromes Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT04053933
• Study type: Observational [Patient Registry]
• Source: University Hospital, Antwerp
• Contact: Bert Heyrman, MD
• Phone: +32.3.280.34.59
• Email: bert.heyrman@zna.be
• Status: Recruiting
• Start date: August 1, 2019
• Completion date: February 1, 2022