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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03075969 |
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Date of registration:
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06/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
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Scientific title:
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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) |
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Date of first enrolment:
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August 3, 2017 |
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Target sample size:
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337 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03075969 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Austria
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Brazil
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China
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France
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Germany
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Iraq
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Italy
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Malaysia
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Netherlands
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Fabio Efficace, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GIMEMA Foundation |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Myeloid Leukemia
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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QoL-CML 0916
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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