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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

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ClinicalTrials.gov Identifier: NCT02378701
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
MDS Clinical Research Consortium
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Leukemia Behavioral: QUALMS-1 Questionnaire Behavioral: FACT-An Questionnaire

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.

This is an investigational study.

Up to 240 participants will be enrolled in this multicenter study. Up to 80 will take part at MD Anderson.


Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 2015
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023


Group/Cohort Intervention/treatment
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
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
Other Name: Survey

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with myelodysplastic syndrome (MDS) taking part in the 2014-0112 study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378701


Contacts
Contact: Guillermo Garcia-Manero, MD 713-745-3428

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
MDS Clinical Research Consortium
Investigators
Principal Investigator: Guillermo Garcia-Manero, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02378701     History of Changes
Other Study ID Numbers: 2014-0636
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Myelodysplastic syndrome
Quality of Life in Myelodysplasia Scale
Leukemia
MDS
Low- or intermediate-1-risk
Chronic Myelomonocytic Leukemia -1
CMML-1
QUALMS-1
Anemia Subset of FACT
FACT-An
Questionnaires
Surveys

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions