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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Brief Summary:

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

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.
Study Design
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Study Type : Observational
Actual Enrollment : 927 participants
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
Actual Study Start Date : October 2, 2008
Actual Primary Completion Date : October 8, 2018
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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.

  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. To devise a prognostic patient-based index. [ Time Frame: After 5 years from study entry. ]
  8. To evaluate accuracy of clinical prediction of survival. [ Time Frame: After 5 years from study entry. ]
  9. 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. ]

Eligibility Criteria
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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
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 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Fabio Efficace, PhD Gruppo Italiano Malattie EMatologiche dell'Adulto
More Information
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Publications:

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00809575    
Obsolete Identifiers: NCT00872768
Other Study ID Numbers: QOL-MDS0108
GIMEMA-QOL-MDS-0108
EU-20885
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
adult
de novo myelodysplastic syndromes
Quality of life
Patient reported outcomes
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
 Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms