Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00809575
First received: December 16, 2008
Last updated: January 21, 2014
Last verified: January 2014
  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
Adult
Myelodysplastic Syndromes
Other: questionnaire administration
Other: fatigue assessment and management
Other: observation
Other: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in High-risk Myelodysplastic Syndromes. A Large-scale International, Observational Study.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • To detect, at least, a 10% change in the hazard ratio for overall survival for every 10-point shift (worse or better) on the patient's reported fatigue scale of the EORTC QLQ-C30. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To prospectively evaluate short-term QoL and symptoms. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in future therapeutic trials. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To investigate the prognostic value of early changes of QoL and symptoms (from baseline to week 4) for overall survival and disease progression (i.e. AML transformation; defined as an increase of blasts to a level of ≥20%). [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To investigate the prognostic value of various baseline patients' reported QoL and symptoms for overall survival and AML transformation. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To devise a prognostic patient-based index. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To evaluate accuracy of clinical prediction of survival. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]
  • To compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians. [ Time Frame: After six years from study entry. ] [ Designated as safety issue: No ]

Estimated Enrollment: 265
Study Start Date: November 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.

  Eligibility

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

Adult patients with myelodysplastic syndromes (MDS).

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.
  • 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 have 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.
  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: NCT00809575

  Show 57 Study Locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Fabio Efficace, PhD Gruppo Italiano Malattie EMatologiche dell'Adulto
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00809575     History of Changes
Obsolete Identifiers: NCT00872768
Other Study ID Numbers: QOL-MDS0108, GIMEMA-QOL-MDS-0108, EU-20885
Study First Received: December 16, 2008
Last Updated: January 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
adult
de novo myelodysplastic syndromes
Quality of life
Patient reported outcomes

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

ClinicalTrials.gov processed this record on September 18, 2014