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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: Leukemia
Myelodysplastic syndrome
MDS
Low- or intermediate-1-risk
Chronic Myelomonocytic Leukemia -1
CMML-1
Quality of Life in Myelodysplasia Scale
QUALMS-1
Anemia Subset of FACT
FACT-An
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: MDS Clinical Research Consortium
First posted: 2015-03-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with myelodysplastic syndrome (MDS) taking part in the 2014-0112 study.

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 criteria: Inclusion Criteria:

1. Sign an Institutional Review Board (IRB)-approved informed consent document.
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:

1. Breast feeding females
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

Primary outcomes:
measure: Change in Quality of Life (QOL)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Guillermo Garcia-Manero, MD
role: PRINCIPAL_INVESTIGATOR
References: