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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|ClinicalTrials.gov Identifier: NCT02378701|
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : September 5, 2018
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Behavioral: QUALMS-1 Questionnaire Behavioral: FACT-An Questionnaire|
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.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|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|
|Actual Study Start Date :||February 2015|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
Quality of Life in Myelodysplasia Scale (QUALMS-1)
Participants complete the Quality of Life in Myelodysplasia Scale (QUALMS-1) and the Anemia Subset of FACT (FACT-An), instrument twice: at the start of treatment, and after four cycles or discontinuation of treatment, whichever comes first.
Behavioral: QUALMS-1 Questionnaire
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Other Name: Survey
Behavioral: FACT-An Questionnaire
Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Other Name: Survey
- Change in Quality of Life (QOL) [ Time Frame: 4 months ]Participants rate any change in their quality of life since enrollment using a 7-point Likert-type change rating scale, ranging from much better, to no change, to much worse. This change rating scale used to characterize the QUALMS-1's reliability compared to its first administration as well as its responsiveness.
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): NCT02378701
|Contact: Guillermo Garcia-Manero, MD||713-745-3428|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Maryland|
|The Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21218|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Weill Medical College of Cornell University||Recruiting|
|New York, New York, United States, 10065|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guillermo Garcia-Manero, MD||M.D. Anderson Cancer Center|