94
Participants
Start Date
November 1, 2019
Primary Completion Date
June 10, 2022
Study Completion Date
July 31, 2022
EMPATHY Pilot
The goal of this pilot is to develop and pilot a tailored monitoring intervention targeting symptomatic, Patient-reported adverse events (AEs) in chronic myeloid leukemia (CML) Patients undergoing first-line tyrosine kinase inhibitor (TKI) therapy. The tailored monitoring intervention will draw primarily from the PRO-CTCAE Item Library, with additional items drawn from the FACIT and EORTC Item libraries as necessary. After identifying the full set of AEs to be monitored, we will load the Patient assessment and report program into tablets for electronic administration in the busy clinic setting. We will then pilot a six-month intervention aimed to monitor and manage emerging AEs, coupled with assessment of intervention feasibility, Patient acceptability and satisfaction, provider acceptability and clinical management utility, adherence to TKI therapy, and HRQoL. We expect that adherence to therapy, clinical response, and HRQoL will be enhanced by such an intervention.
Augusta University, Hematology and Oncology, Augusta
Northwestern University, Robert H. Lurie Comprehensive Cancer Center Comprehensive Cancer Center (RHLCCC), Chicago
Policlinico Sant'Orsola Malpighi - UOC Ematologia - Azienda Ospedaliero-Universitaria di Bologna, Bologna
"Ospedale A. Businco - Struttura Complessa di Ematologia e CTMO - Azienda Ospedaliera G. Brotzu", Cagliari
Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - UOC Oncoematologia - Padiglione Marcora, Milan
"Azienda Ospedaliera Universitaria - Università degli Studi di Napoli Federico II - UOC Ematologia", Napoli
Azienda Ospedaliera Universitaria Maggiore della Carità di Novara - SCDU Ematologia, Novara
AUSL Reggio Emilia - Arcispedale S. Maria Nuova, IRCSS - SC Ematologia, Reggio Emilia
"Azienda Ospedaliera Universitaria Policlinico Umberto I - Università degli Studi Sapienza - UOC Ematologia", Roma
Ospedale Sant'Eugenio, Roma
Azienda Ospedaliero-Universitario Città della Salute e della Scienza di Torino - Ospedale S. Giovanni Battista Molinette - SC Ematologia, Torino
Ospedale Mauriziano Umberto I - Torino - SCDU Ematologia, Torino
"ASUI di Udine - Presidio Ospedaliero Santa Maria della Misericordia - Clinica Ematologica", Udine
Azienda Ospedaliera Universitario Integrata di Verona, Policlinico G.B. Rossi - UOC Ematologia, Verona
USL 6 - Ospedale San Bortolo - Vicenza, Vicenza
The GIMEMA Foundation (Italian Group for Adult Hematologic Diseases), Rome
National Cancer Institute (NCI)
NIH
Fondazione GIMEMA
OTHER
Augusta University
OTHER
Northwestern University
OTHER