The EMPATHY Pilot Study

Completed · Not applicable

Conditions studied: Leukemia, Chronic Myeloid, Cancer

In brief

The proposed study, may significantly contribute to improve healthcare delivery in patients with Chronic Myeloid Leukemia (CML) treated with modern tyrosine kinase inhibitors (TKIs) in two ways. First, it may provide novel empirical data on the positive effects of systematically monitoring of patient-reported adverse events (AEs) in routine practice for improving symptom management and adherence to therapy. Second, it will inform the development of a large international randomized controlled trial (RCT) to test whether systematic collection of patient-reported AEs, could improve clinical response to TKI therapy.

Key facts

Study ID

NCT04384848

Run by

Northwestern University

People needed

94

Starts

2019-11-01

Expected to finish

2022-07-31

Last updated by the study team

2024-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
• Newly diagnosed chronic phase (CP)-CML Patients planned to receive one of the following TKI approved as first line treatment: imatinib, dasatinib, nilotinib or bosutinib;
• Adult Patients (≥18 years) at the time of study entry; Children under the age of 18 will be excluded from the study. The exclusion of children is justified by the following circumstances: a) The condition is relatively rare in children, as compared to adults; b) Issues of study preclude direct applicability of hypotheses and/or interventions to both adults and children.
• Written informed consent.
• Written informed consent from Patient's physician as a participant.
• Newly diagnosed Chronic Phase (CP)-CML Patients who are within 4 weeks of first line TKI therapy (anyone of the TKI approved in the USA and Europe, that is: imatinib, dasatinib, nilotinib or bosutinib).
• Ability to read/converse in English (Northwestern University and Augusta University Sites). Ability to read/converse in Italian (GIMEMA Centers).
• Patient exclusion criteria will include:
• Major cognitive deficits or psychiatric problems hampering a self-reported evaluation;
• Having received any CML treatment - other than TKI - for more than 3 months prior to receiving current TKI therapy.
• This project will focus on CML, which affect both men and women. Therefore, there are no exclusion/inclusion criteria based on sex/gender. In addition, there are no exclusion/inclusion criteria based on race and ethnicity.
• Physician inclusion criteria will include:
• Provider of clinical care for Patient who meets inclusion criteria for the study
• Please note that Physician consent is requisite for the Patient to be enrolled as a participant in the study.

You may not qualify if…

• Major cognitive deficits or psychiatric problems hampering a self-reported evaluation
• Having received any CML treatment prior to therapy with imatinib, dasatinib, bosutinib or nilotinib for more than three months

Where it is running

• Augusta University, Hematology and Oncology — Augusta, Georgia, United States
• Northwestern University, Robert H. Lurie Comprehensive Cancer Center Comprehensive Cancer Center (RHLCCC) — Chicago, Illinois, United States
• Policlinico Sant'Orsola Malpighi - UOC Ematologia - Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy
• Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO - Azienda Ospedaliera G. Brotzu — Cagliari, Italy
• Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - UOC Oncoematologia - Padiglione Marcora — Milan, Italy
• Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - UOC Ematologia — Naples, Italy
• Azienda Ospedaliera Universitaria Maggiore della Carità di Novara - SCDU Ematologia — Novara, Italy
• AUSL Reggio Emilia - Arcispedale S. Maria Nuova, IRCSS - SC Ematologia — Reggio Emilia, Italy
• Azienda Ospedaliera Universitaria Policlinico Umberto I - Università degli Studi "Sapienza" - UOC Ematologia — Roma, Italy
• Ospedale Sant'Eugenio — Roma, Italy
• The GIMEMA Foundation (Italian Group for Adult Hematologic Diseases) — Rome, Italy
• Azienda Ospedaliero-Universitario Città della Salute e della Scienza di Torino - Ospedale S. Giovanni Battista Molinette - SC Ematologia — Torino, Italy
• Ospedale Mauriziano Umberto I - Torino - SCDU Ematologia — Torino, Italy
• ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica — Udine, Italy
• Azienda Ospedaliera Universitario Integrata di Verona, Policlinico G.B. Rossi - UOC Ematologia — Verona, Italy
• USL 6 - Ospedale San Bortolo - Vicenza — Vicenza, Italy

Full record on ClinicalTrials.gov

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