- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378701
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Maryland
-
Baltimore, Maryland, United States, 21218
- The Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
New York
-
New York, New York, United States, 10065
- Weill Medical College of Cornell University
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Other Names:
Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-0636
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Massachusetts General HospitalCelgene CorporationTerminatedAcute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic LeukemiaUnited States
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...RecruitingRefractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, ChildhoodChina
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States
-
Hybrigenics CorporationUnknownAcute Myelogenous LeukemiaUnited States, France
-
Betta Pharmaceuticals Co., Ltd.Not yet recruitingAcute Myeloid Leukemia LeukemiaChina
-
Beijing Boren HospitalRecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapse LeukemiaChina
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationActive, not recruitingAcute Myelogenous LeukemiaUnited States
-
Massachusetts General HospitalCompleted
-
Kinex Pharmaceuticals Inc.CompletedAcute Myelogenous LeukemiaUnited States
Clinical Trials on QUALMS-1 Questionnaire
-
NSABP Foundation IncNational Cancer Institute (NCI)Completed
-
University Hospital, Basel, SwitzerlandCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead And Neck CancerUnited States, China
-
Institut de Recherches Cliniques de MontrealRecruiting
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompletedDiabetic Macular Edema | Retinal Vein Occlusion | Age Related Macular DegenerationFrance
-
Imperial College LondonThe Whittington Hospital NHS TrustUnknown
-
Necmettin Erbakan UniversityEnrolling by invitationPeriodontitis | GingivitisTurkey
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Istituto Ortopedico RizzoliRecruitingOsteoarthritis, Hip | Osteoporotic Fracture of FemurItaly