Completed

NCT Number: 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.

Completed

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Key information

Conditions

Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QUALMS-1 Questionnaire

Behavioral

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

Other names: Survey

FACT-An Questionnaire

Behavioral

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

Other names: Survey

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

MDS Clinical Research Consortium

Registry information

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Mar 4, 2015
Registry last updated: Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed