Patient Reported Outcomes in Chronic Myeloid Leukemia

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
• Overall Status: Completed
• CT.gov ID: NCT01252589
• Collaborator: (none)
• Enrollment: 480
• Locations: 14
• Duration (Months): 34
• Patients Per Site: 34.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Other: HRQOL questionnaire

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 Design

• Study Type: Observational
• Actual Enrollment: 480 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Development of an EORTC questionnaire to assess HRQOL of patients with CML. [By the end of the study.]

Secondary Outcome Measures

1. Comparison between physicians' perception of relevance of HRQOL issues with that of patients. [By the end of the study.]

2. Development of an EORTC CML symptom checklist. [By the end of the study.]

3. HRQOL in CML patients undergoing 2nd line treatment with TKIs. [By the end of the study.]

4. Decision making process for choosing between different 2nd line treatments with TKIs. [By the end of the study.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute Harvard University	Boston	Massachusetts	United States
2	Innsbruck University Hospital	Innsbruck		Austria
3	University of Ghent	Ghent		Belgium
4	Centre Hospitalier Universitaire of Poitiers	Poitiers		France
5	University of Heidelberg	Heidelberg		Germany
6	University of Athens	Athens		Greece
7	University of Baghdad	Baghdad		Iraq
8	Policlinico S. Orsola - Malpighi, Università di Bologna	Bologna		Italy
9	Ematologia Ospedale "Binaghi", Cagliari	Cagliari		Italy
10	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST	Meldola		Italy
11	Ospedale S.Maria delle Croci	Ravenna		Italy
12	Ematologia - Sapienza Università di Roma	Roma		Italy
13	Tilburg University	Tilburg		Netherlands
14	National Taiwan University	Taipei		Taiwan

Sponsors and Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

• Principal Investigator: Fabio Efficace, PhD, GIMEMA DATA CENTER, ROME, ITALY

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• GIMEMA

Publications

• 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.

• Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
• ClinicalTrials.gov Identifier: NCT01252589
• Other Study ID Numbers: QoL - CML0310
• First Posted: Dec 3, 2010
• Last Update Posted: Sep 14, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto: Chronic Myeloid Leukemia; Quality of Life; Symptoms; Patient-Reported outcomes; Questionnaire
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Sep 14, 2016