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
NCT ID: NCT02378701
Last Updated: 2022-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2015-02-28
2022-07-18
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
QUALMS-1 Questionnaire
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
FACT-An Questionnaire
Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Interventions
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QUALMS-1 Questionnaire
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
FACT-An Questionnaire
Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age greater than or equal to 18 years
3. de novo or secondary International Prognostic Scoring Status (IPSS) low- or intermediate-1-risk MDS, including Chronic Myelomonocytic Leukemia (CMML)-1
4. Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to 3 at study entry
5. Organ function as defined below: Serum creatine greater than or equal to mg/dL x upper limit of normal (ULN); Total bilirubin greater than or equal to 2 x ULN; Alanine transaminase (ALT; Serum glutamic pyruvic transaminase=SGPT) greater than or equal to 2 x ULN
6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Exclusion Criteria
2. Prior therapy with decitabine or azacitidine
3. Prior participation in the development of the QUALMS-1 (Dana-Farber Cancer Institute=DFCI)
4. Non-English speaking patients
18 Years
ALL
No
Sponsors
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MDS Clinical Research Consortium
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Guillermo Garcia-Manero, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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2014-0636
Identifier Type: -
Identifier Source: org_study_id
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