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Trial record 3 of 3068 for:    "Myeloid Leukemia"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03075969
Recruitment Status : Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date March 6, 2017
First Posted Date March 9, 2017
Last Update Posted Date March 21, 2019
Actual Study Start Date August 3, 2017
Actual Primary Completion Date March 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2017)
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 ]
Original Primary Outcome Measures
 (submitted: March 6, 2017)
Number of satisfactory answers in relation to patient's quality of life [ Time Frame: 12 months from enrollment ]
Change History Complete list of historical versions of study NCT03075969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 10, 2017)
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 ]
Original Secondary Outcome Measures
 (submitted: March 6, 2017)
Number of valid answers in relation to quality of life of patients [ Time Frame: 12 months from enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
Official Title 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)
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.
Condition Chronic Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 19, 2019)
337
Original Estimated Enrollment
 (submitted: March 6, 2017)
324
Estimated Study Completion Date December 2019
Actual Primary Completion Date March 16, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Brazil,   China,   Germany,   Iraq,   Italy,   Malaysia,   Netherlands,   United States
Removed Location Countries France,   Taiwan,   United Kingdom
 
Administrative Information
NCT Number NCT03075969
Other Study ID Numbers QoL-CML 0916
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators Not Provided
Investigators
Study Chair: Fabio Efficace, PhD GIMEMA Foundation
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date March 2019