Spots Global Cancer Trial Database for Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease
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Trial Identification
Brief Title: Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease
Official Title: Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease
Study ID: NCT02378701
Conditions
Study Description
Brief Summary: The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in patients with MDS. This is an investigational study. Up to 240 participants will be enrolled in this multicenter study. Up to 175 will take part at MD Anderson.
Detailed Description: If you agree to take part in this study, you will be asked to complete questionnaires twice during your participation in the 2014-0112 study. During your first treatment visit, you will be asked to complete the QUALMS-1 questionnaire and another questionnaire that asks about your well-being. After your 4th cycle of treatment or when you stop receiving treatment, you will be asked to complete the QUALMS-1 questionnaire again and another questionnaire to rate any changes in your health since you started the study. It should take about 20 minutes total to complete the questionnaires each time. Information will also be collected from your medical record. This information will include the results of lab tests and other information relating to your health. Length of Study Participation: After you complete the questionnaires the second time, your participation in this study will be complete.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
The Johns Hopkins University, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Weill Medical College of Cornell University, New York, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Guillermo Garcia-Manero, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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