Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes - Full Text View

Sponsored by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00809575

Purpose

RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.

PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.

Condition	Intervention
Fatigue Myelodysplastic Syndromes	Procedure: fatigue assessment and management Procedure: observation Procedure: quality-of-life assessment Procedure: questionnaire administration

U.S. FDA Resources

Study Type:	Observational
Official Title:	Prognostic Significance and Longitudinal Assessment of Patient-Reported Quality of Life and Symptoms in High-Risk Myelodysplastic Syndromes. A Large-Scale International Study.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Prognostic value of pre-treatment fatigue in relation to overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Short-term quality of life (QOL) and symptoms [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Prognostic value of baseline patient-reported QOL and symptoms in relation to AML transformation and overall survival [ Designated as safety issue: No ]
Relationship between patient preferences for involvement in treatment decision-making and patient characteristics [ Designated as safety issue: No ]
Comparison of patient preferences for involvement in treatment decision-making with the perceptions of their treating physicians [ Designated as safety issue: No ]

Estimated Enrollment:	344
Study Start Date:	October 2008
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

PROJECTED ACCRUAL: Approximately 344 patients (230 with intermediate-2 disease and 114 with high-risk disease) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of myelodysplastic syndromes (MDS)
- Newly diagnosed disease (within the past 6 months)
Intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS) classification
- Progressed from lower IPSS risk scores (intermediate-1 or low-risk) that was either previously untreated or treated with ≥ 1 of the following:
  - Transfusions (red blood cells or platelets)
  - Growth factors, chelators, immunosuppression, HDAC inhibitors, or immunomodulatory drugs administered > 4 weeks ago
No leukemia or secondary MDS

PATIENT CHARACTERISTICS:

Able to read and understand local language
No psychiatric disorder or major cognitive dysfunction
No other cancer except epithelial basalioma

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior treatment (including supportive therapy only) for intermediate-2 or high-risk MDS
No prior cytotoxic chemotherapy (high- or low-dose), aza-nucleosides, or transplantation for low-risk or intermediate-1 MDS
Concurrent participation in other therapeutic clinical trials (including investigational therapeutic clinical trials) allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809575

Locations

Italy
Gruppo Italiano Malattie Ematologiche dell'Adulto	Recruiting
Rome, Italy, 00161
Contact: Fabio Efficace, MD 39-4-163-9850

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Principal Investigator:

Fabio Efficace, MD

Gruppo Italiano Malattie EMatologiche dell'Adulto

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000617284, GIMEMA-QOL-MDS-0108, EU-20885
Study First Received:	December 16, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00809575
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
de novo myelodysplastic syndromes

Study placed in the following topic categories:

Myelodysplastic syndromes
Signs and Symptoms
Preleukemia
Fatigue
Precancerous Conditions

Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Quality of Life
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009