Survey on QUality of Life In myeloDisplasia (SQUID)

NCT00967564 | Completed

• 1 other identifier: CR013075
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndrome; Quality of Life; Anemia; Epoetin alfa; Eprex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

001

epidemiologic study QoL assessment

Other: epidemiologic study

Interventions

epidemiologic study OTHER

QoL assessment

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia

Interventions

Epidemiologic Studies

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Janssen-Cilag S.p.A. Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: March 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 28, 2014

Record last verified: 2014-04