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

M.D. Anderson Cancer Center102 enrolled

Overview

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.

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

Enrollment

102

Conditions

Leukemia

Interventions

QUALMS-1 QuestionnaireBEHAVIORAL

Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.

FACT-An QuestionnaireBEHAVIORAL

Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

Change in Quality of Life (QOL)

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.

Time frame: 4 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.