Status:
UNKNOWN
Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Adult
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatme...
Detailed Description
This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This pr...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration.
- Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale).
- Adult patients (≥ 18 years old).
- Written informed consent provided.
- Exclusion criteria
- Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
- Patients with therapy related MDS.
- Having any kind of psychiatric disorder or major cognitive dysfunction.
- Not able to read and understand local language.
Exclusion
Key Trial Info
Start Date :
October 2 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
927 Patients enrolled
Trial Details
Trial ID
NCT00809575
Start Date
October 2 2008
End Date
February 1 2021
Last Update
December 22 2020
Active Locations (53)
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1
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York, United States, 10065
2
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Innsbruck University Hospital
Innsbruck, Austria
4
ZNA Middelheim
Antwerp, Belgium