Interventional Validation of an MDS-Specific Measure of Q... | NCT02378701

Studies
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

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jul 29, 2022Actual

Enrollment

102Actual

Phase

Not provided

Conditions

Leukemia

Interventions

QUALMS-1 Questionnaire
FACT-An Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Jul 18, 2022Actual

Completion Date

Jul 18, 2022Actual

First Submitted Date

Feb 27, 2015

First Submission Date that Met QC Criteria

Feb 27, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2022

Last Update Posted Date

Jul 29, 2022Actual

Name	Class
MDS Clinical Research Consortium	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
QUALMS-1 Questionnaire	Behavioral	Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.	Quality of Life in Myelodysplasia Scale (QUALMS-1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillermo Garcia-Manero, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H. Lee Moffitt Cancer Center and Research Institute		Tampa	Florida	33612	United States
The Johns Hopkins University

ID	Term
D007938	Leukemia
D009190	Myelodysplastic Syndromes

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001855	Bone Marrow Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health