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Trial record 2 of 12 for:    QUALMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053933
Recruitment Status : Unknown
Verified August 2019 by Zwi Berneman, University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Zwi Berneman, University Hospital, Antwerp

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
Myelodysplastic Syndromes

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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 : August 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Change in QUALMS-score [ Time Frame: 6 months ]
    Change in quality of life-score after the start of a new MDS related treatment

  2. Change in IPQ-score [ Time Frame: 6 months ]
    Change of ilness perception score after the start of a new MDS related treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from myelodysplastic syndromes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053933


Contacts
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Contact: Bert Heyrman, MD +32.3.280.34.59 bert.heyrman@zna.be
Contact: Erwin Janssen, MSc be.qualms@zna.be

Locations
Show Show 21 study locations
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Zwi Berneman, MD,PhD University Hospital, Antwerp
  Study Documents (Full-Text)

Documents provided by Zwi Berneman, University Hospital, Antwerp:
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Responsible Party: Zwi Berneman, Professor, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04053933    
Other Study ID Numbers: B300201938708
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zwi Berneman, University Hospital, Antwerp:
QUALMS
MDS
Be-QUALMS
Quality of life
QoL
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms