Patient Reported Outcomes in Chronic Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01252589
First received: December 2, 2010
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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 Intervention
Chronic Myeloid Leukemia
Other: HRQOL questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Development of an EORTC questionnaire to assess HRQOL of patients with CML. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison between physicians' perception of relevance of HRQOL issues with that of patients. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Development of an EORTC CML symptom checklist. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • HRQOL in CML patients undergoing 2nd line treatment with TKIs. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Decision making process for choosing between different 2nd line treatments with TKIs. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adults with CML
Adult patients (18 years of age or older) with confirmed diagnosis of CML
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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

No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01252589     History of Changes
Other Study ID Numbers: QoL - CML0310
Study First Received: December 2, 2010
Last Updated: March 20, 2014
Health Authority: Italy: Ethics Committee

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, Myeloid
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014