LeukemiaNCT02378701
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
An observational study of Leukemia, run by M.D. Anderson Cancer Center at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- QUALMS-1 Questionnaire and FACT-An Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 102 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2015to 18 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with myelodysplastic syndrome (MDS) taking part in the 2014-0112 study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Johns Hopkins University
Baltimore, Maryland, 21218
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Weill Medical College of Cornell University
New York, New York, 10065
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
Read the 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.
- Conditions
- Leukemia
- Being tested
- QUALMS-1 Questionnaire, FACT-An Questionnaire
- 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
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUALMS-1 QuestionnaireBehavioural
Also called Survey
Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
FACT-An QuestionnaireBehavioural
Also called Survey
Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: QUALMS-1 Questionnaire; Behavioral: FACT-An Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- MDS Clinical Research Consortium
- Responsible party
- Sponsor
- Investigators
- Guillermo Garcia-Manero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378701
- Sponsor's protocol ID
- 2014-0636
- Status last verified
- Jul 2022
- First submitted
- 27 Feb 2015
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02378701
- Acronym / sponsor ID
- 2014-0636
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- MDS Clinical Research Consortium
- Study start
- Feb 2015 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Life in Myelodysplasia Scale (QUALMS-1) | – | Behavioral: QUALMS-1 Questionnaire, Behavioral: FACT-An QuestionnaireParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with myelodysplastic syndrome (MDS) taking part in the 2014-0112 study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUALMS-1 QuestionnaireAlso: SurveyParticipants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops. | Behavioural | Quality of Life in Myelodysplasia Scale (QUALMS-1) |
| FACT-An QuestionnaireAlso: SurveyParticipants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops. | Behavioural | Quality of Life in Myelodysplasia Scale (QUALMS-1) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Garcia-Manero, MD principal investigator
M.D. Anderson Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by M.D. Anderson Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QOL) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.