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

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.

• questionnaire administration (Other)
• fatigue assessment and management (Other)
• observation (Other)
• quality-of-life assessment (Other)

Primary outcomes

• To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients. [After 5 years from study entry.]

Secondary outcomes

• To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes. [After 5 years from study entry.]: i.e. overall survival, AML transformation, toxicity and response to therapy.
• To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy. [After 5 years from study entry.]
• To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories. [After 5 years from study entry.]
• To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. [After 5 years from study entry.]
• To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. [After 5 years from study entry.]
• To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes. [After 5 years from study entry.]
• To devise a prognostic patient-based index. [After 5 years from study entry.]
• To evaluate accuracy of clinical prediction of survival. [After 5 years from study entry.]
• To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics. [After 5 years from study entry.]

Sex: All, ages: 18 Years to any

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 3 months before date of registration.
* Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-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.

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• Fabio Efficace, PhD, Principal investigator, Gruppo Italiano Malattie EMatologiche dell'Adulto