Patient Reported Outcomes in Chronic Myeloid Leukemia

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252589
• Other study ID #: QoL - CML0310
• Status: Completed
• Phase: N/A
• First received: December 2, 2010
• Last updated: September 13, 2016
• Start date: November 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2016
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• HRQOL questionnaire

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Greece,  Iraq,  Italy,  Netherlands,  Taiwan, 

References & Publications (1)

Efficace F, Baccarani M, Breccia M, Saussele S, Abel G, Caocci G, Guilhot F, Cocks K, Naeem A, Sprangers M, Oerlemans S, Chie W, Castagnetti F, Bombaci F, Sharf G, Cardoni A, Noens L, Pallua S, Salvucci M, Nicolatou-Galitis O, Rosti G, Mandelli F. International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res. 2014 Apr;23(3):825-36. doi: 10.1007/s11136-013-0523-5. Epub 2013 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of an EORTC questionnaire to assess HRQOL of patients with CML.		By the end of the study.	No
Secondary	Comparison between physicians' perception of relevance of HRQOL issues with that of patients.		By the end of the study.	No
Secondary	Development of an EORTC CML symptom checklist.		By the end of the study.	No
Secondary	HRQOL in CML patients undergoing 2nd line treatment with TKIs.		By the end of the study.	No
Secondary	Decision making process for choosing between different 2nd line treatments with TKIs.		By the end of the study.	No

External Links

•   EORTC Quality of Life Group
•   GIMEMA