Clinical trial NCT00967564: Survey on QUality of Life In myeloDisplasia (SQUID)
Official title: QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndrome
Quality of Life
Anemia
Epoetin alfa
Eprex
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatients

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between quality of life and hemoglobin in patients with new diagnosis of myelodysplastic syndrome
timeFrame: At baseline, at week 12, and at months 12 and 18
Secondary outcomes:
measure: Correlation between Hb changes and QoL changes
timeFrame: At baseline, at week 12, and at months 12 and 18 of observation
measure: Comparison between the patient's and physician's QoL perception
timeFrame: At baseline, at week 12, and at months 12 and 18 of observation
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A. Clinical Trial
role: STUDY_DIRECTOR
References: