Survey on QUality of Life In myeloDisplasia (SQUID)

Myelodysplastic Syndromes Clinical Trial

Official title:

QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967564
• Other study ID #: CR013075
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2009
• Last updated: April 24, 2014
• Start date: March 2007
• Est. completion date: November 2009

Study information

• Verified date: April 2014
• Source: Janssen-Cilag S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

Other:
• epidemiologic study
QoL assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between quality of life and hemoglobin in patients with new diagnosis of myelodysplastic syndrome		At baseline, at week 12, and at months 12 and 18	No
Secondary	Correlation between Hb changes and QoL changes		At baseline, at week 12, and at months 12 and 18 of observation	No
Secondary	Comparison between the patient's and physician's QoL perception		At baseline, at week 12, and at months 12 and 18 of observation	No