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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378701
• Other study ID #: 2014-0636
• Status: Completed
• Start date: February 2015
• Est. completion date: July 18, 2022

Study information

• Verified date: July 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Behavioral:
• QUALMS-1 Questionnaire
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
• FACT-An Questionnaire
Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Weill Medical College of Cornell University	New York	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	MDS Clinical Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website