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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00809575
First received: December 16, 2008
Last updated: May 18, 2015
Last verified: May 2015
  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 Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS 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 5 years from study entry. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 5 years from study entry. ] [ Designated as safety issue: No ]
  • To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]
  • To devise a prognostic patient-based index. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]
  • To evaluate accuracy of clinical prediction of survival. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]
  • To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]
  • To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]
  • To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. [ Time Frame: After 5 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 clinical trials. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]
  • To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes. [ Time Frame: After 5 years from study entry. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1070
Study Start Date: November 2008
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 6 months before date of registration.
  • Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5DFACIT-Fatigue and Control Preference Scale).
  • Adult patients (≥ 18 years old).
  • Written informed consent provided.

Exclusion criteria

  • Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
  • Patients with therapy related 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

Contacts
Contact: Francesca Tartaglia promys@gimema.it

  Show 60 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:
Publications:
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: May 18, 2015
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
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on May 27, 2015