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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Unknown status

CT.gov ID

NCT04053933

Collaborator

(none)

350

Enrollment

Locations

30.1

Anticipated Duration (Months)

16.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients treated with ESA
Patients treated with 5'azacitidin
Patients treated with deferoxamine
Patients treated with deferasirox
Patients treated with transfusion only
Patients treated with lenalidomide
Patients treated with intensive chemotherapy

Outcome Measures

Primary Outcome Measures

Change in QUALMS-score [6 months]
Change in quality of life-score after the start of a new MDS related treatment
Change in IPQ-score [6 months]
Change of ilness perception score after the start of a new MDS related treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.
Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.
Signed informed consent

Exclusion criteria

Patients with acute leukemia defined as >20% bone marrow blasts.
Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this case the disease has both dysplastic and proliferative features but cannot be properly categorized to either group. This category includes chronic myelomonocytic leukemia (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.
Patients in post allogeneic transplant setting.
Patients enrolled in a blinded interventional therapeutic trial.
Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.
Newly diagnosed patients who do not start with treatment.
Patients who started a previous MDS related treatment less then 4 weeks ago.
Patients who started a previous MDS related treatment less then 12 weeks ago apart from packed cell transfusions.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imelda	Bonheiden	Antwerpen	Belgium	2820
2	AZ KLINA	Brasschaat	Antwerpen	Belgium	2930
3	Sint-Dimpna Ziekenhuis Geel	Geel	Antwerpen	Belgium	2240
4	Heilig Hart Ziekenhuis	Lier	Antwerpen	Belgium	2500
5	UZA	Edegem	Antwerp	Belgium	2650
6	CH Jolimont	La Louvière	Henegouwen	Belgium	7100
7	CHR Mons Hainaut	Mons	Henegouwen	Belgium	7000
8	CHU Ambroise Paré	Mons	Henegouwen	Belgium	7000
9	CHU - UCL Namur site Godinne	Yvoir	Namur	Belgium	5530
10	UZ Gent	Gent	Oost Vlaanderen	Belgium	9000
11	AZ Nikolaas	Sint-Niklaas	Oost Vlaanderen	Belgium	9100
12	Institute Jules Bordet	Brussel	Vlaams Brabant	Belgium	1000
13	UZ Brussel	Jette	Vlaams Brabant	Belgium	1090
14	UZ Leuven Gasthuisberg	Leuven	Vlaams Brabant	Belgium	3000
15	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert	Vlaams Brabant	Belgium	1200
16	AZ Sint Jan Brugge	Brugge	West Vlaanderen	Belgium	8000
17	AZ Damiaan Oostende	Oostende	West Vlaanderen	Belgium	8400
18	Ziekenhuis Netwerk Antwerpen	Antwerpen		Belgium	2020
19	GasthuisZusters Antwerpen	Antwerpen		Belgium	2610
20	CHR Namur	Namur		Belgium	5000
21	BR Clinic Saint Pierre Ottignies	Ottignies-Louvain-la-Neuve		Belgium