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Survey on QUality of Life In myeloDisplasia (SQUID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier:
NCT00967564
First received: August 27, 2009
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Myelodysplastic Syndromes
Other: epidemiologic study
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag S.p.A.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between Hb changes and QoL changes [ Time Frame: At baseline, at week 12, and at months 12 and 18 of observation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
epidemiologic study QoL assessment
Other: epidemiologic study
QoL assessment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

outpatients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967564

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

No publications provided

Responsible Party: Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier: NCT00967564     History of Changes
Other Study ID Numbers: CR013075
Study First Received: August 27, 2009
Last Updated: April 24, 2014
Health Authority: Italy: National Institute of Health

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on November 24, 2014