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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 : Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date December 16, 2008
First Posted Date December 17, 2008
Last Update Posted Date February 26, 2019
Actual Study Start Date October 2, 2008
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2017)
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. ]
Original Primary Outcome Measures
 (submitted: December 16, 2008)
Prognostic value of pre-treatment fatigue in relation to overall survival
Change History Complete list of historical versions of study NCT00809575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 24, 2017)
  • 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. ]
Original Secondary Outcome Measures
 (submitted: December 16, 2008)
  • Short-term quality of life (QOL) and symptoms
  • Prognostic value of early changes in QOL and symptoms (from baseline to week 4) in relation to acute myeloid leukemia (AML) transformation and overall survival
  • Prognostic value of baseline patient-reported QOL and symptoms in relation to AML transformation and overall survival
  • Relationship between patient preferences for involvement in treatment decision-making and patient characteristics
  • Comparison of patient preferences for involvement in treatment decision-making with the perceptions of their treating physicians
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes
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
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with myelodysplastic syndromes (MDS).
Condition
  • Adult
  • Myelodysplastic Syndromes
Intervention
  • Other: questionnaire administration
  • Other: fatigue assessment and management
  • Other: observation
  • Other: quality-of-life assessment
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 25, 2019)
929
Original Estimated Enrollment
 (submitted: December 16, 2008)
344
Estimated Study Completion Date February 2020
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility 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 6 months before date of registration.
  • Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5DFACIT-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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Austria,   Belgium,   China,   Czechia,   France,   Germany,   Italy,   South Africa,   Taiwan,   United Kingdom,   United States
Removed Location Countries Croatia,   Czech Republic,   India,   Netherlands
 
Administrative Information
NCT Number NCT00809575
Other Study ID Numbers QOL-MDS0108
GIMEMA-QOL-MDS-0108
EU-20885
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators Not Provided
Investigators
Principal Investigator: Fabio Efficace, PhD Gruppo Italiano Malattie EMatologiche dell'Adulto
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date February 2019