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 : Completed
First Posted : March 4, 2015
Last Update Posted : July 29, 2022
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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|
|Actual Enrollment :||102 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|
|Actual Primary Completion Date :||July 18, 2022|
|Actual Study Completion Date :||July 18, 2022|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Sign an Institutional Review Board (IRB)-approved informed consent document.
- Age greater than or equal to 18 years
- de novo or secondary International Prognostic Scoring Status (IPSS) low- or intermediate-1-risk MDS, including Chronic Myelomonocytic Leukemia (CMML)-1
- Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to 3 at study entry
- 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
- 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.
- Breast feeding females
- Prior therapy with decitabine or azacitidine
- Prior participation in the development of the QUALMS-1 (Dana-Farber Cancer Institute=DFCI)
- Non-English speaking patients
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
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Maryland|
|The Johns Hopkins University|
|Baltimore, Maryland, United States, 21218|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guillermo Garcia-Manero, MD||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
|First Posted:||March 4, 2015 Key Record Dates|
|Last Update Posted:||July 29, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Low- or intermediate-1-risk
Chronic Myelomonocytic Leukemia -1
Quality of Life in Myelodysplasia Scale
Anemia Subset of FACT
Neoplasms by Histologic Type
Bone Marrow Diseases