Survey on QUality of Life In myeloDisplasia (SQUID)

Myelodysplastic Syndromes Clinical Trial

Official title: QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation

Clinical Trial Description

In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia has been associated with increased cardiac disease which, in older patients, may aggravate pre-existing conditions such as congestive heart failure. Patients with MDS often require red blood cell transfusions that further deteriorate patients' perception of well-being. This is an 18-month prospective observational investigation about the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of white blood cells that fights against infection) or low level of platelets (irregularly shaped cells found in blood that help prevent bleeding) - will be included in the evaluation. Demographic and disease-specific data will be collected and QoL will be evaluated by a specific questionnaire named QoL-E which will be completed both by patients and respective physicians. Study visits will be performed monthly until week 12; the subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be collected during the study, only adverse reaction to any Janssen-Cilag drug should be reported. This information may be important to optimize treatment according to patients' preferences and expectations, to detect functional complications, as well as to improve communication between patients and caregivers. Observational study - No study drug was administered. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT00967564
• Study type: Observational
• Source: Janssen-Cilag S.p.A.
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Completion date: November 2009