An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)

Gruppo Italiano Malattie EMatologiche dell'Adulto32 sites in 9 countries337 target enrollmentAugust 3, 2017

ConditionsChronic Myeloid Leukemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Myeloid Leukemia
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Enrollment: 337
Locations: 32
Primary Endpoint: The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.

Registry

clinicaltrials.gov

Start Date

August 3, 2017

End Date

December 2019

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Above 18 years of age.
•Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
•Written informed consent.
•Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Exclusion Criteria

•Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.
•Patients who are unable to speak and read the language of the questionnaire.

Outcomes

Primary Outcomes

The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML.

Time Frame: 18 months from enrollment

Secondary Outcomes

The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24).(18 months from enrollment)