Chronic Myeloid LeukemiaNCT01252589
Patient Reported Outcomes in Chronic Myeloid Leukemia
An observational study of Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 14 sites in 10 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- HRQOL questionnaire
- How many people
- 480 participants
- Where
- 14 sitesin 10 countries
- Study dates
- Nov 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18 years of age or older) with confirmed diagnosis of Philadelphia chromosome positive CML undergoing all possible treatments available.
Who may be able to join
- 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
Who cannot join
- Freedom from overt cognitive impairment or major psychiatric conditions that may confound HRQOL evaluation
Trial locations and contacts
14 sites in 10 countries.
14 sites in 10 countries
Italy5 sites
Policlinico S. Orsola - Malpighi, Università di Bologna
Bologna
Ematologia Ospedale "Binaghi", Cagliari
Cagliari
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST
Meldola
Ospedale S.Maria delle Croci
Ravenna
Ematologia - Sapienza Università di Roma
Roma
United States1 site
Dana-Farber Cancer Institute Harvard University
Boston, Massachusetts
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- HRQOL questionnaire
- Keywords
- Chronic Myeloid Leukemia, Quality of Life, Symptoms, Patient-Reported outcomes, Questionnaire
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRQOL questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Adults with CML | Adult patients (18 years of age or older) with confirmed diagnosis of CML Receives: Other: HRQOL questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an EORTC questionnaire to assess HRQOL of patients with CML.
Measured: By the end of the study.
Secondary outcomes (4)
Comparison between physicians' perception of relevance of HRQOL issues with that of patients.
Measured: By the end of the study.
Development of an EORTC CML symptom checklist.
Measured: By the end of the study.
HRQOL in CML patients undergoing 2nd line treatment with TKIs.
Measured: By the end of the study.
Decision making process for choosing between different 2nd line treatments with TKIs.
Measured: By the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Efficace, PhD, Principal investigator, GIMEMA DATA CENTER, ROME, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252589
- Sponsor's protocol ID
- QoL - CML0310
- Status last verified
- Sep 2016
- First submitted
- 2 Dec 2010
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24026634
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.
- ClinicalTrials.gov ID
- NCT01252589
- Acronym / sponsor ID
- QoL - CML0310
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic Myeloid Leukemia, Quality of Life, Symptoms, Patient-Reported outcomes, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with CML | – | Other: HRQOL questionnaireAdult patients (18 years of age or older) with confirmed diagnosis of CML |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years of age or older) with confirmed diagnosis of Philadelphia chromosome positive CML undergoing all possible treatments available.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Freedom from overt cognitive impairment or major psychiatric conditions that may confound HRQOL evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRQOL questionnaire | Other | Adults with CML |
Primary outcome
Development of an EORTC questionnaire to assess HRQOL of patients with CML.
Time frame: By the end of the study.
4 secondary outcomes
Comparison between physicians' perception of relevance of HRQOL issues with that of patients.
Time frame: By the end of the study.
Development of an EORTC CML symptom checklist.
Time frame: By the end of the study.
HRQOL in CML patients undergoing 2nd line treatment with TKIs.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 24026634Efficace 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.
- GIMEMALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Efficace, PhD principal investigator
GIMEMA DATA CENTER, ROME, ITALY
14 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 14 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, United States, Austria, Belgium, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an EORTC questionnaire to assess HRQOL of patients with CML. (time frame: By the end of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.