Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 16, 2019

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
    • Time Frame: 18 months from enrollment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gruppo Italiano Malattie EMatologiche dell’Adulto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fabio Efficace, PhD, Study Chair, GIMEMA Foundation

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