Chronic Myeloid LeukemiaNCT03075969
Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
An observational study of Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 32 sites in 9 countries.
Trial summary
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- How many people
- 337 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 3 Aug 2017to Dec 2019
- 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: The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.
Who may be able to join
- Above 18 years of age.
- Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
- Written informed consent.
- Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.
Who cannot join
- Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.
- Patients who are unable to speak and read the language of the questionnaire.
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
Italy24 sites
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona
Azienda Ospedaliero-Universitaria Policlinico Consorziale
Bari
Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna
Bologna
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125
CTMO - Ematologia - Ospedale Binaghi
Cagliari
Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
Catania
Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST
Genova
Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano
Milan
Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"
Novara
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
Palermo
U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma
Parma
Div. di Ematologia IRCCS Policlinico S. Matteo
Pavia, 27100
Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"
Roma
Divisione di Ematologia - Ospedale S.Eugenio
Roma
Divisione Ematologia - Università Campus Bio-Medico
Roma
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
U.O. di Ematologia - Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ematologia - AOU Sassari
Sassari
U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona
Verona
Ospedale San Bortolo
Vicenza, 36100
United States1 site
Winship Cancer Institute of Emory University
Emory, Georgia, 30322
Brazil1 site
Complexo Hospital de Clinicas da Universidade Federal do Parana
Paranã
Malaysia1 site
UCSI University, Faculty of Pharmaceutical Sciences
Kuala Lumpur
About this study
Official title: An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic myeloid leukemia; quality of life
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML.
Measured: 18 months from enrollment
Secondary outcomes (1)
The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24).
Measured: 18 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start3 Aug 2017
- Primary completion16 Mar 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 337 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, Study chair, GIMEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075969
- Sponsor's protocol ID
- QoL-CML 0916
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)
- ClinicalTrials.gov ID
- NCT03075969
- Acronym / sponsor ID
- QoL-CML 0916
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic myeloid leukemia; quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 16 Mar 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Mar 2017 (actual)
- 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.
The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.
Key inclusion criteria (4 listed)
- Above 18 years of age.
- Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
- Written informed consent.
- Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.
Key exclusion criteria (2 listed)
- Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.
- Patients who are unable to speak and read the language of the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML.
Time frame: 18 months from enrollment
1 secondary outcome
The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24).
Time frame: 18 months from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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 study chair
GIMEMA Foundation
32 sites in 9 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 32 sites in 9 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy, United States, Austria, Brazil, China and 4 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?
Results are not available in the source record.
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?
The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML. (time frame: 18 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2019.