Trial record 2 of 12 for:
QUALMS
Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL (Be-QUALMS)
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| ClinicalTrials.gov Identifier: NCT04053933 |
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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
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Sponsor:
University Hospital, Antwerp
Information provided by (Responsible Party):
Zwi Berneman, University Hospital, Antwerp
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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 |
| 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
MedlinePlus related topics:
Myelodysplastic Syndromes
| 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 :
- Change in QUALMS-score [ Time Frame: 6 months ]Change in quality of life-score after the start of a new MDS related treatment
- 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.
| 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
| Contact: Bert Heyrman, MD | +32.3.280.34.59 | bert.heyrman@zna.be | |
| Contact: Erwin Janssen, MSc | be.qualms@zna.be |
Locations
Show 21 study locations
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
| Principal Investigator: | Zwi Berneman, MD,PhD | University Hospital, Antwerp |
Study Documents (Full-Text)
Documents provided by Zwi Berneman, University Hospital, Antwerp:
Documents provided by Zwi Berneman, University Hospital, Antwerp:
Study Protocol and Statistical Analysis Plan [PDF] July 7, 2019
| 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 |
| 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:
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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 |