Patient Reported Outcomes in Chronic Myeloid Leukemia

Completed

Conditions studied: Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01252589

Run by

Gruppo Italiano Malattie EMatologiche dell'Adulto

People needed

480

Starts

2010-11-01

Expected to finish

2013-09-01

Last updated by the study team

2016-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Dana-Farber Cancer Institute Harvard University — Boston, Massachusetts, United States
• Innsbruck University Hospital — Innsbruck, Austria
• University of Ghent — Ghent, Belgium
• Centre Hospitalier Universitaire of Poitiers — Poitiers, France
• University of Heidelberg — Heidelberg, Germany
• University of Athens — Athens, Greece
• University of Baghdad — Baghdad, Iraq
• 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
• Tilburg University — Tilburg, Netherlands
• National Taiwan University — Taipei, Taiwan

Full record on ClinicalTrials.gov

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