Clinical Trials Directory

Trials / Unknown

UnknownNCT00809575

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

Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study

Status
Unknown
Phase
Study type
Observational
Enrollment
927 (actual)
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERquestionnaire administration
OTHERfatigue assessment and management
OTHERobservation
OTHERquality-of-life assessment

Timeline

Start date
2008-10-02
Primary completion
2018-10-08
Completion
2021-02-01
First posted
2008-12-17
Last updated
2020-12-22

Locations

53 sites across 12 countries: United States, Austria, Belgium, Brazil, China, Croatia, Czechia, France, Germany, Italy, Taiwan, United Kingdom

Source: ClinicalTrials.gov record NCT00809575. Inclusion in this directory is not an endorsement.