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Patient Reported Outcomes in Chronic Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01252589
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:

Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison.

The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose.

The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.


Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Other: HRQOL questionnaire

Detailed Description:

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).


Study Type : Observational
Actual Enrollment : 480 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.
Study Start Date : November 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


Group/Cohort Intervention/treatment
Adults with CML
Adult patients (18 years of age or older) with confirmed diagnosis of CML
Other: HRQOL questionnaire



Primary Outcome Measures :
  1. Development of an EORTC questionnaire to assess HRQOL of patients with CML. [ Time Frame: By the end of the study. ]

Secondary Outcome Measures :
  1. Comparison between physicians' perception of relevance of HRQOL issues with that of patients. [ Time Frame: By the end of the study. ]
  2. Development of an EORTC CML symptom checklist. [ Time Frame: By the end of the study. ]
  3. HRQOL in CML patients undergoing 2nd line treatment with TKIs. [ Time Frame: By the end of the study. ]
  4. Decision making process for choosing between different 2nd line treatments with TKIs. [ Time Frame: By the end of the study. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (18 years of age or older) with confirmed diagnosis of Philadelphia chromosome positive CML undergoing all possible treatments available.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252589


Locations
United States, Massachusetts
Dana-Farber Cancer Institute Harvard University
Boston, Massachusetts, United States
Austria
Innsbruck University Hospital
Innsbruck, Austria
Belgium
University of Ghent
Ghent, Belgium
France
Centre Hospitalier Universitaire of Poitiers
Poitiers, France
Germany
University of Heidelberg
Heidelberg, Germany
Greece
University of Athens
Athens, Greece
Iraq
University of Baghdad
Baghdad, Iraq
Italy
Policlinico S. Orsola - Malpighi, Università di Bologna
Bologna, Italy
Ematologia Ospedale "Binaghi", Cagliari
Cagliari, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST
Meldola, Italy
Ospedale S.Maria delle Croci
Ravenna, Italy
Ematologia - Sapienza Università di Roma
Roma, Italy
Netherlands
Tilburg University
Tilburg, Netherlands
Taiwan
National Taiwan University
Taipei, Taiwan
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Fabio Efficace, PhD GIMEMA DATA CENTER, ROME, ITALY

Additional Information:
GIMEMA  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01252589     History of Changes
Other Study ID Numbers: QoL - CML0310
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic Myeloid Leukemia
Quality of Life
Symptoms
Patient-Reported outcomes
Questionnaire

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases