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

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT03075969
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-09
• Study Start: 2017-08-03
• Status Verified: 2019-03
• Primary Completion: 2019-03-16
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 337

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	18 months from enrollment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (32)

Winship Cancer Institute of Emory University; 🇺🇸 Emory, Georgia, United States

Innsbruck Medical University; 🇦🇹 Innsbruck, Austria

Complexo Hospital de Clinicas da Universidade Federal do Parana; 🇧🇷 Paranã, Brazil

Guangdong Medical University; 🇨🇳 Guangdong, China

Universität Heidelberg; 🇩🇪 Heidelberg, Germany

Baghdad Teaching Hospital; 🇮🇶 Baghdad, Iraq

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi; 🇮🇹 Ancona, Italy

Azienda Ospedaliero-Universitaria Policlinico Consorziale; 🇮🇹 Bari, Italy

Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna; 🇮🇹 Bologna, Italy

Sezione di Ematologia e Trapianti Spedali Civili; 🇮🇹 Brescia, Italy

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