Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 6:58 PM
Study NCT ID:
NCT04053933
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL
Sponsor:
University Hospital, Antwerp
Organization:
Study Overview
Official Title:
A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Be-QUALMS
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: