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 Website: www.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
