Survey on QUality of Life In myeloDisplasia (SQUID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier:
NCT00967564
First received: August 27, 2009
Last updated: April 24, 2014
Last verified: April 2014

August 27, 2009
April 24, 2014
March 2007
November 2009   (final data collection date for primary outcome measure)
Correlation between quality of life and hemoglobin in patients with new diagnosis of myelodysplastic syndrome [ Time Frame: At baseline, at week 12, and at months 12 and 18 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967564 on ClinicalTrials.gov Archive Site
  • Correlation between Hb changes and QoL changes [ Time Frame: At baseline, at week 12, and at months 12 and 18 of observation ] [ Designated as safety issue: No ]
  • Comparison between the patient's and physician's QoL perception [ Time Frame: At baseline, at week 12, and at months 12 and 18 of observation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Survey on QUality of Life In myeloDisplasia (SQUID)
QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

outpatients

Myelodysplastic Syndromes
Other: epidemiologic study
QoL assessment
001
epidemiologic study QoL assessment
Intervention: Other: epidemiologic study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary or secondary MDS
  • At least one cytopenia according to International Prognostic Score System (IPSS) criteria (Hb < 10 g/dL
  • Absolute neutrophils count (a type of white cell that fights against infection) < 1.800/µL
  • platelets (irregularly shaped cells found in blood that help prevent bleeding) < 100.000/µL)
  • Willing and able, based on investigator's judgment, to fill in QoL questionnaires

Exclusion Criteria:

  • Refractory anemia with excess blasts (tumor cells located in the marrow > 20%)
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) >3
  • History of cerebrovascular disease with cognitive outcomes
  • Psychiatric diseases or senile or vascular dementia
  • Positive anamnesis for another clinically active tumor or when treatment has been stopped since less than 5 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00967564
CR013075
Not Provided
Janssen-Cilag S.p.A.
Janssen-Cilag S.p.A.
Not Provided
Study Director: Janssen-Cilag S.p.A. Clinical Trial Janssen-Cilag S.p.A.
Janssen-Cilag S.p.A.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP