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

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Other: epidemiologic study

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
• Enrollment (Actual): 160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

outpatients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001; epidemiologic study QoL assessment	Other: epidemiologic study; QoL assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between Hb changes and QoL changes	At baseline, at week 12, and at months 12 and 18 of observation
Comparison between the patient's and physician's QoL perception	At baseline, at week 12, and at months 12 and 18 of observation

Collaborators and Investigators

• Sponsor: Janssen-Cilag S.p.A.
• Investigators: Study Director: Janssen-Cilag S.p.A. Clinical Trial, Janssen-Cilag S.p.A.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Quality of Life; Anemia; Epoetin alfa; Myelodysplastic Syndrome; Eprex
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: CR013075