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PROMYS

GIMEMA QoL Study -MDS0108 - Prognostic significance and longitudinal assessment of Patient-Reported Outcomes in MYelodysplastic Syndromes (PROMYS) - (PROMYS International Registry)

Project Objectives

The primary objective is to assess whether the level of fatigue, as perceived by the patient, may be a prognostic factor of survival in patients with recently diagnosed myelodysplastic syndrome.

The secondary objectives are to:

  • Evaluate the change in different parameters of quality of life (QoL) and symptoms in the course of the disease to verify whether this change has a prognostic value for clinical progression (e.g. for survival, toxicity or response to treatment) and for the risk of transformation into acute leukemia.
  • Prospectively evaluate the subjective health (QoL and symptoms) in the short and long term, according to the clinical risk of disease development and the type of treatment performed.
  • Compare subjective health (QoL and symptoms) of patients affected by low-risk myelodysplastic syndrome with that of patients affected by myelodysplastic syndrome with a higher risk type or acute leukemia.
  • Establish benchmark data for a series of parameters of QoL and symptoms, present at the onset of the disease, to be used in future clinical trials as comparison data
  • Evaluate the effect of transfusion dependence at the onset or during clinical progress of the disease on the different parameters of QoL and symptoms, as reported by patients
  • Explore the possibility to develop a prognostic index also based on subjective values of health as perceived by the patient
  • Evaluate the accuracy of clinical predictions of life expectancy made by the treating physician and based on his/her subjective evaluations at enrollment
  • Evaluate the level of satisfaction of patients related to their involvement in decision-making on treatment, according to the clinical risk of disease, and the socio-demographic and clinical characteristics of the patients themselves
  • Compare the preferences expressed by patients with those expressed by doctors regarding the involvement of patients in the decision-making mechanism of treatment choice

Official Websitewww.gimema.it

Start/End Date

April 23, 2009 - 2019

Principal Investigator

Prof. Giuseppe Avvisati

Host Institution

Fondazione GIMEMA

Other Institutions involved

Institutions included in the “Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA)”

Source of funding

Fondazione GIMEMA

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