Patient Reported Outcomes in Chronic Myeloid Leukemia

NCT01252589 | Completed

• 1 other identifier: QoL - CML0310
• Study Type: observational
• Target: 480
• Locations: 10 countries
• Sites: 14

Brief 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.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic Myeloid Leukemia; Quality of Life; Symptoms; Patient-Reported outcomes; Questionnaire

Outcome Measures

Primary Outcomes (1)

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

  By the end of the study.

Secondary Outcomes (4)

• Comparison between physicians' perception of relevance of HRQOL issues with that of patients.

  By the end of the study.

• Development of an EORTC CML symptom checklist.

  By the end of the study.

• HRQOL in CML patients undergoing 2nd line treatment with TKIs.

  By the end of the study.

• Decision making process for choosing between different 2nd line treatments with TKIs.

  By the end of the study.

Study Arms (1)

Adults with CML

Adult patients (18 years of age or older) with confirmed diagnosis of CML

Other: HRQOL questionnaire

Interventions

HRQOL questionnaire OTHER

Adults with CML

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (14)

Dana-Farber Cancer Institute Harvard University

Boston, Massachusetts, United States

Location

Innsbruck University Hospital

Innsbruck, Austria

Location

University of Ghent

Ghent, Belgium

Location

Centre Hospitalier Universitaire of Poitiers

Poitiers, France

Location

University of Heidelberg

Heidelberg, Germany

Location

University of Athens

Athens, Greece

Location

University of Baghdad

Baghdad, Iraq

Location

Policlinico S. Orsola - Malpighi, Università di Bologna

Bologna, Italy

Location

Ematologia Ospedale "Binaghi", Cagliari

Cagliari, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST

Meldola, Italy

Location

Ospedale S.Maria delle Croci

Ravenna, Italy

Location

Ematologia - Sapienza Università di Roma

Roma, Italy

Location

Tilburg University

Tilburg, Netherlands

Location

National Taiwan University

Taipei, Taiwan

Location

Related 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.

  PMID: 24026634 BACKGROUND

Related Links

• GIMEMA

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabio Efficace, PhD

  GIMEMA DATA CENTER, ROME, ITALY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

BE (1); DE (1); TW (1); US (1); GR (1); NL (1); AU (1); FR (1); IR (1); IT (5)