Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes (PROMYS)
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|ClinicalTrials.gov Identifier: NCT00809575|
Recruitment Status : Unknown
Verified December 2020 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was: Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : December 22, 2020
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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 or disease||Intervention/treatment|
|Adult Myelodysplastic Syndromes||Other: questionnaire administration Other: fatigue assessment and management Other: observation Other: quality-of-life assessment|
|Study Type :||Observational|
|Actual Enrollment :||927 participants|
|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|
|Actual Study Start Date :||October 2, 2008|
|Actual Primary Completion Date :||October 8, 2018|
|Estimated Study Completion Date :||February 2021|
- To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients. [ Time Frame: After 5 years from study entry. ]
- To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: After 5 years from study entry. ]
- 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. ]
- To devise a prognostic patient-based index. [ Time Frame: After 5 years from study entry. ]
- To evaluate accuracy of clinical prediction of survival. [ Time Frame: 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. [ Time Frame: After 5 years from study entry. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809575
|Principal Investigator:||Fabio Efficace, PhD||Gruppo Italiano Malattie EMatologiche dell'Adulto|
|Responsible Party:||Gruppo Italiano Malattie EMatologiche dell'Adulto|
|Other Study ID Numbers:||
|First Posted:||December 17, 2008 Key Record Dates|
|Last Update Posted:||December 22, 2020|
|Last Verified:||December 2020|
de novo myelodysplastic syndromes
Quality of life
Patient reported outcomes
Bone Marrow Diseases