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

NCT02378701 | Completed

• 1 other identifier: 2014-0636
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Study Arms (1)

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; Behavioral: FACT-An Questionnaire

Interventions

QUALMS-1 Questionnaire BEHAVIORAL

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

Also known as: Survey

Quality of Life in Myelodysplasia Scale (QUALMS-1)

FACT-An Questionnaire BEHAVIORAL

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

Also known as: Survey

Quality of Life in Myelodysplasia Scale (QUALMS-1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with myelodysplastic syndrome (MDS) taking part in the 2014-0112 study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• MDS Clinical Research Consortium: collaborator

Study Sites (6)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guillermo Garcia-Manero, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2015
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

US (6)