Chronic Myeloid Leukemia Clinical Trial
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)
| Verified date | March 2019 |
| Source | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 337 |
| Est. completion date | December 2019 |
| Est. primary completion date | March 16, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Innsbruck Medical University | Innsbruck | |
| Brazil | Complexo Hospital de Clinicas da Universidade Federal do Parana | Paranã | |
| China | Guangdong Medical University | Guangdong | |
| Germany | Universität Heidelberg | Heidelberg | |
| Iraq | Baghdad Teaching Hospital | Baghdad | |
| Italy | Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi | Ancona | |
| Italy | Azienda Ospedaliero-Universitaria Policlinico Consorziale | Bari | |
| Italy | Department of Oncology and Hematology, O.U. of Hematology, S. Orsola-Malpighi University Hospital, Bologna | Bologna | |
| Italy | Sezione di Ematologia e Trapianti Spedali Civili | Brescia | |
| Italy | CTMO - Ematologia - Ospedale Binaghi | Cagliari | |
| Italy | Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto | Catania | |
| Italy | Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST | Genova | |
| Italy | Lecce ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | Lecce | |
| Italy | U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano | Milano | |
| Italy | Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato" | Novara | |
| Italy | Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone | Palermo | |
| Italy | U.O.C. di Ematologia e CTMO Az. Ospedaliero Universitaria Parma | Parma | |
| Italy | Div. di Ematologia IRCCS Policlinico S. Matteo | Pavia | |
| Italy | Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto | Piacenza | |
| Italy | Dipartimento Oncologico - Ospedale S.Maria delle Croci | Ravenna | |
| Italy | Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova | Reggio Emilia | |
| Italy | Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza" | Roma | |
| Italy | Divisione di Ematologia - Ospedale S.Eugenio | Roma | |
| Italy | Divisione Ematologia - Università Campus Bio-Medico | Roma | |
| Italy | Università Cattolica del Sacro Cuore - Policlinico A. Gemelli | Roma | |
| Italy | U.O. di Ematologia - Casa Sollievo della Sofferenza | San Giovanni Rotondo | |
| Italy | Ematologia - AOU Sassari | Sassari | |
| Italy | U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona | Verona | |
| Italy | Ospedale San Bortolo | Vicenza | |
| Malaysia | UCSI University, Faculty of Pharmaceutical Sciences | Kuala Lumpur | |
| Netherlands | Eindhoven and Tilburg University | Eindhoven | |
| United States | Winship Cancer Institute of Emory University | Emory | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Gruppo Italiano Malattie EMatologiche dell'Adulto |
United States, Austria, Brazil, China, Germany, Iraq, Italy, Malaysia, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 18 months from enrollment | ||
| Secondary | 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). | 18 months from enrollment |
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