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CLINICAL UTILITY OF ONLINE MONITORING OF PATIENT-REPORTED SYMPTOMS IN NEWLY DIAGNOSED PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN REAL-LIFE PRACTICE
Author(s): ,
Fabio Efficace
Affiliations:
Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italie;Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italien;Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italia;Data Center and Health Outcomes Research Unit,Italian Group for
,
Francesco Cottone
Affiliations:
Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italie;Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italien;Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italia;Data Center and Health Outcomes Research Unit,Italian Group for
,
Betina Yanez
Affiliations:
Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,États-unis;Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,Vereinigte Staaten;Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,Stati Uniti;Department of Medical Social Sciences,Northwestern University Fe
,
Fausto Castagnetti
Affiliations:
Department of Experimental, Diagnostic and Specialty Medicine,S. Orsola-Malpighi Hospital, University of Bologna,Bologna,Italie;Department of Experimental, Diagnostic and Specialty Medicine,S. Orsola-Malpighi Hospital, University of Bologna,Bologna,Italien;Department of Experimental, Diagnostic and Specialty Medicine,S. Orsola-Malpighi Hospital, University of Bologna,Bologna,Italia;Department of E
,
Giovanni Caocci
Affiliations:
Department of Medical Sciences and Public Health,University of Cagliari, Businco Hospital,Cagliari,Italie;Department of Medical Sciences and Public Health,University of Cagliari, Businco Hospital,Cagliari,Italien;Department of Medical Sciences and Public Health,University of Cagliari, Businco Hospital,Cagliari,Italia;Department of Medical Sciences and Public Health,University of Cagliari, Businco
,
Massimiliano Bonifacio
Affiliations:
Section of Hematology, Department of Medicine,University of Verona,Verona,Italie;Section of Hematology, Department of Medicine,University of Verona,Verona,Italien;Section of Hematology, Department of Medicine,University of Verona,Verona,Italia;Section of Hematology, Department of Medicine,University of Verona,Verona,Italy;Section of Hematology, Department of Medicine,University of Verona,Verona,It
,
Andrea Patriarca
Affiliations:
Division of Hematology, Department of Translational Medicine,University of Eastern Piedmont,Novara,Italie;Division of Hematology, Department of Translational Medicine,University of Eastern Piedmont,Novara,Italien;Division of Hematology, Department of Translational Medicine,University of Eastern Piedmont,Novara,Italia;Division of Hematology, Department of Translational Medicine,University of Easter
,
Isabella Capodanno
Affiliations:
Hematology Unit,Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia,Reggio Emilia,Italie;Hematology Unit,Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia,Reggio Emilia,Italien;Hematology Unit,Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia,Reggio Emilia,Italia;Hematology Unit,Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia,Reggio Emilia,Italy;Hematology Unit,Azienda Unità Sanita
,
Maria Cristina Miggiano
Affiliations:
Hematology Department,San Bortolo Hospital,Vicenza,Italie;Hematology Department,San Bortolo Hospital,Vicenza,Italien;Hematology Department,San Bortolo Hospital,Vicenza,Italia;Hematology Department,San Bortolo Hospital,Vicenza,Italy;Hematology Department,San Bortolo Hospital,Vicenza,Italia;Hematology Department,San Bortolo Hospital,Vicenza,Italië;Hematology Department,San Bortolo Hospital,Vicenza,I
,
Mario Tiribelli
Affiliations:
Division of Hematology and BMT, Department of Medical Area,University of Udine,Udine,Italie;Division of Hematology and BMT, Department of Medical Area,University of Udine,Udine,Italien;Division of Hematology and BMT, Department of Medical Area,University of Udine,Udine,Italia;Division of Hematology and BMT, Department of Medical Area,University of Udine,Udine,Italy;Division of Hematology and BMT,
,
Massimo Breccia
Affiliations:
Hematology, Department of Translational and Precision Medicine,Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome,Rome,Italie;Hematology, Department of Translational and Precision Medicine,Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome,Rome,Italien;Hematology, Department of Translational and Precision Medicine,Azienda Ospedaliera Policlinico Umberto I, S
,
Luigia Luciano
Affiliations:
Haematology Unit "Federico II",University of Naples,Naples,Italie;Haematology Unit "Federico II",University of Naples,Naples,Italien;Haematology Unit "Federico II",University of Naples,Naples,Italia;Haematology Unit "Federico II",University of Naples,Naples,Italy;Haematology Unit "Federico II",University of Naples,Naples,Italia;Haematology Unit "Federico II",University of Naples,Naples,Italië;Haem
,
Valentina Giai
Affiliations:
Hematology Unit,Azienda Ospedaliero-Universitaria Città della Salute e della Scienza,Torino,Italie;Hematology Unit,Azienda Ospedaliero-Universitaria Città della Salute e della Scienza,Torino,Italien;Hematology Unit,Azienda Ospedaliero-Universitaria Città della Salute e della Scienza,Torino,Italia;Hematology Unit,Azienda Ospedaliero-Universitaria Città della Salute e della Scienza,Torino,Italy;Hema
,
Alessandra Iurlo
Affiliations:
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico,Milano,Italie;Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico,Milano,Italien;Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico,Milano,Italia;Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico,Milano,Italy;Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico,Milano,Italia;Foundation IRCCS Ca' Granda Ospedale Mag
,
Elisabetta Abruzzese
Affiliations:
Hemoglobinopathies Unit, Hematology Department,S. Eugenio Hospital (ASL Roma 2),Rome,Italie;Hemoglobinopathies Unit, Hematology Department,S. Eugenio Hospital (ASL Roma 2),Rome,Italien;Hemoglobinopathies Unit, Hematology Department,S. Eugenio Hospital (ASL Roma 2),Rome,Italia;Hemoglobinopathies Unit, Hematology Department,S. Eugenio Hospital (ASL Roma 2),Rome,Italy;Hemoglobinopathies Unit, Hematol
,
Carmen Fava
Affiliations:
Department of Clinical and Biological Sciences,University of Turin,Turin,Italie;Department of Clinical and Biological Sciences,University of Turin,Turin,Italien;Department of Clinical and Biological Sciences,University of Turin,Turin,Italia;Department of Clinical and Biological Sciences,University of Turin,Turin,Italy;Department of Clinical and Biological Sciences,University of Turin,Turin,Italia;
,
Gianantonio Rosti
Affiliations:
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) "Dino Amadori",Meldola,Italie;IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) "Dino Amadori",Meldola,Italien;IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) "Dino Amadori",Meldola,Italia;IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
,
Jorge Cortes
Affiliations:
Georgia Cancer Center, Augusta University Medical Center,Augusta,États-unis;Georgia Cancer Center, Augusta University Medical Center,Augusta,Vereinigte Staaten;Georgia Cancer Center, Augusta University Medical Center,Augusta,Stati Uniti;Georgia Cancer Center, Augusta University Medical Center,Augusta,United States;Georgia Cancer Center, Augusta University Medical Center,Augusta,Estados Unidos;Geor
,
Vamsi Kota
Affiliations:
Georgia Cancer Center, Augusta University Medical Center,Augusta,États-unis;Georgia Cancer Center, Augusta University Medical Center,Augusta,Vereinigte Staaten;Georgia Cancer Center, Augusta University Medical Center,Augusta,Stati Uniti;Georgia Cancer Center, Augusta University Medical Center,Augusta,United States;Georgia Cancer Center, Augusta University Medical Center,Augusta,Estados Unidos;Geor
,
Marco Vignetti
Affiliations:
Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italie;Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italien;Data Center and Health Outcomes Research Unit,Italian Group for Adult Hematologic Diseases (GIMEMA),Rome,Italia;Data Center and Health Outcomes Research Unit,Italian Group for
David Cella
Affiliations:
Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,États-unis;Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,Vereinigte Staaten;Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,Stati Uniti;Department of Medical Social Sciences,Northwestern University Fe
(Abstract release date: 05/12/22) EHA Library. Efficace F. 06/10/22; 358563; P1706
Prof. Fabio Efficace
Prof. Fabio Efficace
Contributions
Abstract
Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P1706

Type: Poster presentation

Session title: Quality of life, palliative care, ethics and health economics

Background
Adherence to tyrosine kinase inhibitors (TKIs) is critical to maximize clinical effectiveness of drugs in patients with chronic myeloid leukemia (CML). However, adverse events (AEs) are one of the most frequent causes for non-adherence to TKI therapy.

Aims

We herein report patients’ and physicians’ perception of using a newly developed online tool for patient-reported AEs monitoring in newly diagnosed CML patients in real-life practice. We also report health-related quality of life (HRQoL) and fatigue of patients up to six months.

Methods
An online platform (EMPATHY) for systematic monitoring of patient-reported AEs (including a set 22 items mainly derived from the PRO-CTCAE Item Library) was developed for the purpose of this study. Newly diagnosed CML patients within 4 weeks of first line TKI therapy were eligible. At the time of a clinical visit (after having signed informed consent), and just before the consultation with the physician, patients were provided a tablet PC to self-rate (touchscreen) their symptoms. The local clinical research staff instructed patients on study procedures and on how to complete self- reported AEs via tablet. Patient-reported AEs were displayed graphically and available, in real time, to physicians’ PC during the clinical consultation. At 3- and 6-months both patients and physicians completed a Survey assessing acceptability, satisfaction and clinical utility of using this platform. At these time points, patient-reported HRQoL and fatigue were also assessed with the FACT-G and PROMIS-Fatigue questionnaires (via paper copies), respectively. Trajectories over time were estimated using a linear mixed model for repeated measures.

Results
Ninety-four newly diagnosed CML patients were enrolled between July 2020 and August 2021 in 15 centers across US and Italy. There were 43% of patients treated with imatinib and 31%, 24% and 2%, treated with nilotinib, dasatinib and bosutinib, respectively. Median age of patients was 57 years (range, 19-82 years) and 55% were male. Sokal-risk was low in 42% of patients and 34% had at least one comorbidity. The majority of them (73%) used internet on a regular basis. The platform was generally well received by patients, for example, 99% (77/78) and 94% (73/78) of them agreeing or strongly agreeing (at 3 months) that it was easy to use and improved quality of communication with their physician, respectively. Of the 21 physicians (median age of 42 years) involved, nearly all (20/21; 95%) agreed that it was a valuable tool for improving accuracy of symptomatic AE of their patients. Similar high percentages were observed at 6 months. Compliance with patient-reported HRQoL and fatigue assessments was 99%, 93% and 93% at baseline, 3 and 6 months, respectively. No statistically significant differences were observed for the FACT-G and the PROMIS-Fatigue scores over time in the overall population.

Conclusion
Current data suggest that the EMPATHY platform is well accepted by patients and physicians and its use may contribute to enhance physicians’ ability to better understand symptom burden of their patients.

Keyword(s): Chronic myeloid leukemia, Patient reported outcomes, Quality of life

Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P1706

Type: Poster presentation

Session title: Quality of life, palliative care, ethics and health economics

Background
Adherence to tyrosine kinase inhibitors (TKIs) is critical to maximize clinical effectiveness of drugs in patients with chronic myeloid leukemia (CML). However, adverse events (AEs) are one of the most frequent causes for non-adherence to TKI therapy.

Aims

We herein report patients’ and physicians’ perception of using a newly developed online tool for patient-reported AEs monitoring in newly diagnosed CML patients in real-life practice. We also report health-related quality of life (HRQoL) and fatigue of patients up to six months.

Methods
An online platform (EMPATHY) for systematic monitoring of patient-reported AEs (including a set 22 items mainly derived from the PRO-CTCAE Item Library) was developed for the purpose of this study. Newly diagnosed CML patients within 4 weeks of first line TKI therapy were eligible. At the time of a clinical visit (after having signed informed consent), and just before the consultation with the physician, patients were provided a tablet PC to self-rate (touchscreen) their symptoms. The local clinical research staff instructed patients on study procedures and on how to complete self- reported AEs via tablet. Patient-reported AEs were displayed graphically and available, in real time, to physicians’ PC during the clinical consultation. At 3- and 6-months both patients and physicians completed a Survey assessing acceptability, satisfaction and clinical utility of using this platform. At these time points, patient-reported HRQoL and fatigue were also assessed with the FACT-G and PROMIS-Fatigue questionnaires (via paper copies), respectively. Trajectories over time were estimated using a linear mixed model for repeated measures.

Results
Ninety-four newly diagnosed CML patients were enrolled between July 2020 and August 2021 in 15 centers across US and Italy. There were 43% of patients treated with imatinib and 31%, 24% and 2%, treated with nilotinib, dasatinib and bosutinib, respectively. Median age of patients was 57 years (range, 19-82 years) and 55% were male. Sokal-risk was low in 42% of patients and 34% had at least one comorbidity. The majority of them (73%) used internet on a regular basis. The platform was generally well received by patients, for example, 99% (77/78) and 94% (73/78) of them agreeing or strongly agreeing (at 3 months) that it was easy to use and improved quality of communication with their physician, respectively. Of the 21 physicians (median age of 42 years) involved, nearly all (20/21; 95%) agreed that it was a valuable tool for improving accuracy of symptomatic AE of their patients. Similar high percentages were observed at 6 months. Compliance with patient-reported HRQoL and fatigue assessments was 99%, 93% and 93% at baseline, 3 and 6 months, respectively. No statistically significant differences were observed for the FACT-G and the PROMIS-Fatigue scores over time in the overall population.

Conclusion
Current data suggest that the EMPATHY platform is well accepted by patients and physicians and its use may contribute to enhance physicians’ ability to better understand symptom burden of their patients.

Keyword(s): Chronic myeloid leukemia, Patient reported outcomes, Quality of life

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