Patient Reported Outcomes in Chronic Myeloid Leukemia

September 13, 2016 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck University Hospital
  • Belgium
      • Ghent, Belgium
        • University of Ghent
  • France
      • Poitiers, France
        • Centre Hospitalier Universitaire of Poitiers
  • Germany
      • Heidelberg, Germany
        • University of Heidelberg
  • Greece
      • Athens, Greece
        • University of Athens
  • Iraq
      • Baghdad, Iraq
        • University of Baghdad
  • Italy
      • Bologna, Italy
        • Policlinico S. Orsola - Malpighi, Università di Bologna
      • Cagliari, Italy
        • Ematologia Ospedale "Binaghi", Cagliari
      • Meldola, Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST
      • Ravenna, Italy
        • Ospedale S.Maria delle Croci
      • Roma, Italy
        • Ematologia - Sapienza Università di Roma
  • Netherlands
      • Tilburg, Netherlands
        • Tilburg University
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana-Farber Cancer Institute Harvard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of an EORTC questionnaire to assess HRQOL of patients with CML.
Time Frame: By the end of the study.
By the end of the study.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoL - CML0310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Myeloid Leukemia

Clinical Trials on HRQOL questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe