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Survey on QUality of Life In myeloDisplasia (SQUID)

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ClinicalTrials.gov Identifier: NCT00967564
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : April 28, 2014
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

Brief 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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Other: epidemiologic study Phase 4

Detailed 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 Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2007
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
epidemiologic study QoL assessment
Other: epidemiologic study
QoL assessment

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Correlation between Hb changes and QoL changes [ Time Frame: At baseline, at week 12, and at months 12 and 18 of observation ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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): NCT00967564

Sponsors and Collaborators
Janssen-Cilag S.p.A.
Study Director: Janssen-Cilag S.p.A. Clinical Trial Janssen-Cilag S.p.A.

Responsible Party: Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier: NCT00967564     History of Changes
Other Study ID Numbers: CR013075
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by Janssen-Cilag S.p.A.:
Myelodysplastic Syndrome
Quality of Life
Epoetin alfa

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions