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Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.


The development process will follow the international guidelines published by the EORTC
Quality of Life Group (QLG). This process will follow three main phases.

Phase 1 of will deal with the review of the literature, identification of an item list and
interviews with experts in the treatment of CML and CML patients (undergoing all possible
treatments).

In Phase II the identified issues from Phase I will be worded and translated into possible
items for the provisional questionnaire using existing EORTC questionnaires and the EORTC
QLG Item Bank.

In the Phase III the provisional CML questionnaire will be pre-tested by to a larger sample
of CML patients (not the same patients involved in previous phases) and individual
structured interviews will be conducted as well. These latter will identify questions that
might be irrelevant or whether there will be additional issues not previously included.

Overall up to 480 patients will be enrolled in this study (up to 180 in phase I and up to
300 in phase III).


Inclusion Criteria:



- Adult patients (18 years of age or older)

- Confirmed diagnosis of Philadelphia chromosome positive CML

- Informed consent provided

- Patients enrolled in investigational treatment trials are eligible

- Ability to speak and read language of the Questionnaire

Exclusion Criteria:

- Freedom from overt cognitive impairment or major psychiatric conditions that may
confound HRQOL evaluation

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Development of an EORTC questionnaire to assess HRQOL of patients with CML.

Safety Issue:

No

Principal Investigator

Fabio Efficace, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GIMEMA DATA CENTER, ROME, ITALY

Authority:

Italy: Ethics Committee

Study ID:

QoL - CML0310

NCT ID:

NCT01252589

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Quality of Life
  • Symptoms
  • Patient-Reported outcomes
  • Questionnaire
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Dana-Farber Cancer Institute Harvard UniversityBoston, Massachusetts