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

Completed

• Conditions: Leukemia
• Interventions: Behavioral: QUALMS-1 Questionnaire; Behavioral: FACT-An Questionnaire

• Registration Number: NCT02378701
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-04
• Status Verified: 2022-07
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-18
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Quality of Life in Myelodysplasia Scale (QUALMS-1)	FACT-An Questionnaire	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.
Quality of Life in Myelodysplasia Scale (QUALMS-1)	QUALMS-1 Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (QOL)	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.

Trial Locations

Locations (6)

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

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States