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NCT Number: NCT01252589

Patient Reported Outcomes in Chronic Myeloid Leukemia

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck University Hospital, Innsbruck, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRQOL questionnaire

Other

Primary outcomes

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

    Time frame: By the end of the study.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 3, 2010
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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