Patient Reported Outcomes in Chronic Myeloid Leukemia | NCT01252589

Studies
Patient Reported Outcomes in Chronic Myeloid Leukemia

NCT01252589

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Completed

Last Update Posted

Sep 14, 2016Estimated

Enrollment

480Actual

Phase

Not provided

Conditions

Chronic Myeloid Leukemia

Interventions

HRQOL questionnaire

Countries

United States
Austria
Belgium
France
Germany
Greece
Iraq
Italy
Netherlands
Taiwan

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

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

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

Nov 2010

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Dec 2, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

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

Sep 13, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison.

The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose.

The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

Detailed Description

The development process will follow the international guidelines published by the EORTC Quality of Life Group (QLG). This process will follow three main phases.

Phase 1 of will deal with the review of the literature, identification of an item list and interviews with experts in the treatment of CML and CML patients (undergoing all possible treatments).

In Phase II the identified issues from Phase I will be worded and translated into possible items for the provisional questionnaire using existing EORTC questionnaires and the EORTC QLG Item Bank.

In the Phase III the provisional CML questionnaire will be pre-tested by to a larger sample of CML patients (not the same patients involved in previous phases) and individual structured interviews will be conducted as well. These latter will identify questions that might be irrelevant or whether there will be additional issues not previously included.

Overall up to 480 patients will be enrolled in this study (up to 180 in phase I and up to 300 in phase III).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults with CML		Adult patients (18 years of age or older) with confirmed diagnosis of CML	Other: HRQOL questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HRQOL questionnaire	Other		Adults with CML

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of an EORTC questionnaire to assess HRQOL of patients with CML.		By the end of the study.

Secondary Outcomes

Measure	Description	Time Frame
Comparison between physicians' perception of relevance of HRQOL issues with that of patients.		By the end of the study.
Development of an EORTC CML symptom checklist.		By the end of the study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (18 years of age or older)
Confirmed diagnosis of Philadelphia chromosome positive CML
Informed consent provided
Patients enrolled in investigational treatment trials are eligible
Ability to speak and read language of the Questionnaire

Exclusion Criteria:

Freedom from overt cognitive impairment or major psychiatric conditions that may confound HRQOL evaluation

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

Adult patients (18 years of age or older) with confirmed diagnosis of Philadelphia chromosome positive CML undergoing all possible treatments available.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabio Efficace, PhD	GIMEMA DATA CENTER, ROME, ITALY	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Cancer Institute Harvard University		Boston	Massachusetts		United States
Innsbruck University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24026634	Background	Efficace F, Baccarani M, Breccia M, Saussele S, Abel G, Caocci G, Guilhot F, Cocks K, Naeem A, Sprangers M, Oerlemans S, Chie W, Castagnetti F, Bombaci F, Sharf G, Cardoni A, Noens L, Pallua S, Salvucci M, Nicolatou-Galitis O, Rosti G, Mandelli F. International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res. 2014 Apr;23(3):825-36. doi: 10.1007/s11136-013-0523-5. Epub 2013 Sep 13.

Type	Date	Date Unknown
Release	Jan 16, 2018
Reset	Sep 19, 2018

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms