Survey on QUality of Life In myeloDisplasia (SQUID)

Overview

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

Full Title of Study: “QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2009

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.

Interventions

  • Other: epidemiologic study
    • QoL assessment

Arms, Groups and Cohorts

  • 001
    • epidemiologic study QoL assessment

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Correlation between Hb changes and QoL changes
    • Time Frame: At baseline, at week 12, and at months 12 and 18 of observation
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen-Cilag S.p.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen-Cilag S.p.A. Clinical Trial, Study Director, Janssen-Cilag S.p.A.

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