Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in High-risk Myelodysplastic Syndromes. A Large-scale International Study.
18 Years
N/A
Both
Fatigue, Myelodysplastic Syndromes
Trial Information
Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in High-risk Myelodysplastic Syndromes. A Large-scale International Study.
OBJECTIVES:
Primary
- To investigate the prognostic value of pre-treatment patient-reported fatigue in
relation to overall survival of patients with newly diagnosed intermediate-2 or
high-risk myelodysplastic syndromes according to the International Prognostic Scoring
System classification.
Secondary
- To prospectively evaluate short-term quality of life (QOL) and symptoms.
- To establish international baseline QOL and symptom reference data to be used as
benchmarks for comparisons in future studies.
- To investigate the prognostic value of early changes in QOL and symptoms (from baseline
to week 4) in relation to acute myeloid leukemia (AML) transformation and overall
survival.
- To investigate the prognostic value of various baseline patient-reported QOL and
symptoms in relation to AML transformation and overall survival.
- To devise a prognostic patient-based index.
- To assess patient preferences for involvement in treatment decision-making and the
relationship between patient preferences and patient characteristics.
- To compare patient preferences for involvement in treatment decision-making with the
perceptions of their treating physicians.
OUTLINE: This is a multicenter study.
Patients complete EORTC QLQ-C30, FACIT-Fatigue Scale, and Control Preference Scale
questionnaires at baseline, 4 weeks, and 8 weeks.
Inclusion Criteria
Inclusion criteria
- Patients with newly diagnosed myelodysplastic syndrome (MDS) with IPSS risk score of
intermediate-2 and high-risk. The diagnosis of MDS with IPSS risk score of
intermediate-2 and high-risk is acceptable within 6 months before date of
registration;
- Patients with IPSS risk score of intermediate-2 and high-risk who have progressed
from lower IPSS risk scores (intermediate 1 or low) and have received any kind of
treatment (except for transplantation).
- Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; FACIT-Fatigue
and Control Preference Scale);
- Adult patients (≥ 18 years old);
- Written informed consent provided;
- Patients who has been enrolled onto other study therapy protocols (including
investigational protocol treatments) are also eligible.
Exclusion criteria
- Patients already diagnosed of MDS with IPSS risk score of intermediate-2 and
high-risk who have received treatment except for supportive therapy with
transfusions;
- Prior history of leukaemia or other cancers (excluding epithelial basalioma) and
patients with secondary MDS;
- Having any kind of psychiatric disorder or major cognitive dysfunction;
- Not able to read and understand local language.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Prognostic value of pre-treatment fatigue in relation to overall survival
Safety Issue:
No
Principal Investigator
Fabio Efficace, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Authority:
Italy: Ethics Committee
Study ID:
QOL-MDS0108
NCT ID:
NCT00809575
Start Date:
November 2008
Completion Date:
Related Keywords:
- Fatigue
- Myelodysplastic Syndromes
- fatigue
- de novo myelodysplastic syndromes
- Fatigue
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| University of Chicago | Chicago, Illinois 60637 |
| The University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |
| University of Southern California (USC) | Los Angeles, California 90007 |
| Memorial Sloan-Kettering Cancer Center (MSKCC) | New York, New York 10065 |
