Evidence map›Paper›PMID 37801052›Full record

Trial reportCancer2024

Patient-reported symptom monitoring and adherence to therapy in patients with newly diagnosed chronic myeloid leukemia.

Fabio Efficace, Francesco Cottone, Betina Yanez, Vamsi Kota, Fausto Castagnetti, Giovanni Caocci, Massimiliano Bonifacio, Andrea Patriarca, Isabella Capodanno, Maria Cristina Miggiano and 13 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04384848 (Evaluating Patient-Reported Outcomes Monitoring in Routine Care of Patients With Chronic Myeloid Leukemia for Increasing Adherence and Clinical Response to THerapY), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04384848 nacompletednot on this map

Evaluating Patient-Reported Outcomes Monitoring in Routine Care of Patients With Chronic Myeloid Leukemia for Increasing Adherence and Clinical Response to THerapY: The EMPATHY Pilot Study

TypeinterventionalSponsorNorthwestern UniversityRan2019 to 2022Enrolled94ConditionsLeukemia, Chronic Myeloid, CancerArmsEMPATHY Pilot
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Electronic patient-reported outcome platforms used in hematological cancers: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
  2. Feasibility and preliminary effects of mhealth supportive care interventions in adults with myeloid neoplasms: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
  3. Pooled it
  4. Trial
  5. Psychometric evaluation of the PROMISJournal of patient-reported outcomes · 2026
    Observational
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 17 institutions in 2 countries.

Fabio EfficaceItalian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.ORCID 0000-0002-5065-5166
Francesco CottoneItalian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
Betina YanezDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID 0000-0003-1503-0600
Vamsi KotaGeorgia Cancer Center, Augusta University Medical Center, Augusta, Georgia, USA.ORCID 0000-0002-5290-9289
Fausto CastagnettiHematology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Giovanni CaocciDepartment of Medical Sciences and Public Health, University of Cagliari, Businco Hospital, Cagliari, Italy.
Massimiliano BonifacioDepartment of Engineering for Innovation Medicine, Section of Innovation Biomedicine, Hematology Area, University of Verona, Verona, Italy.ORCID 0000-0003-0716-1686
Andrea PatriarcaDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.
Isabella CapodannoHematology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Maria Cristina MiggianoHematology Department, San Bortolo Hospital, Vicenza, Italy.
Mario TiribelliDivision of Hematology and Bone Marrow Transplantation, Department of Medical Area, University of Udine, Udine, Italy.ORCID 0000-0001-9449-2621
Massimo BrecciaHematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.ORCID 0000-0003-1163-6162
Luigia LucianoHematology Unit "Federico II,", University of Naples, Naples, Italy.
Valentina GiaiHematology Unit, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Turin, Italy.
Alessandra IurloFoundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0000-0002-4401-0812
Elisabetta AbruzzeseHemoglobinopathies Unit, Hematology Department, S. Eugenio Hospital (ASL Roma 2), Rome, Italy.ORCID 0000-0001-5228-6491
Carmen FavaDepartment of Clinical and Biological Sciences, University of Turin, Turin, Italy.
Shira DinnerRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Jessica K AltmanRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Gianantonio RostiIRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Jorge CortesGeorgia Cancer Center, Augusta University Medical Center, Augusta, Georgia, USA.
Marco VignettiItalian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
David CellaDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Northwestern University · USAugusta University Health · USFondazione Gimema Onlus · ITASL Roma · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITAzienda USL di Bologna · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITOspedale San Bortolo · ITPoliclinico Umberto I · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity of Cagliari · ITUniversity of Naples Federico II · ITUniversity of Turin · ITUniversity of Udine · ITUniversity of Verona · IT

Funding

Evaluating Patient-Reported Outcomes Monitoring in Routine Care of Patients with Chronic Myeloid Leukemia for Increasing Adherence and Clinical Response to THerapY: TheEMPATHY Pilot StudyR21CA230367 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI CELLA, DAVID, EFFICACE, FABIO · 2019 to 2020
$362k
National Institutes of Health/National Cancer Institute 1R21CA230367-01A1NCI NIH HHS R21 CA230367
6 · The paper itself

Abstract

backgroundThe authors assessed the clinical utility of patient-reported symptom monitoring in the setting of newly diagnosed chronic myeloid leukemia (CML). The primary objective was to evaluate adherence to therapy.

methodsThe authors conducted an international prospective study that included patients with newly diagnosed, chronic-phase CML. Before clinical consultation, patients were provided a tablet computer to self-rate their symptoms, and the results were available in real time to each physician during the patient's visit. Adherence was assessed by pill count and with a validated self-reported questionnaire. The proportions of optimal responders at 3 and 6 months were assessed according to the European LeukemiaNet criteria.

resultsBetween July 2020 and August 2021, 94 patients with a median age of 57 years were enrolled. Pill count adherence analysis indicated that 86 of 93 evaluable patients (92.5%) took at least 90% of prescribed tyrosine kinase inhibitor therapy during the 6-month observation period. The online platform was well accepted by patients and physicians. An optimal response was achieved by 69 of 79 patients (87.3%) at 3 months and by 61 of 81 patients (75.3%) at 6 months.

conclusionsPatient-reported symptom monitoring from the beginning of therapy in patients with CML may be critical to improve adherence to therapy and early molecular response rates (ClinicalTrials.gov identifier NCT04384848).

Indexed as

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseHumansMedication AdherenceMiddle AgedPatient Reported Outcome MeasuresProspective Studiesadherencechronic myeloid leukemiadigital healthmolecular responsequality of lifesymptoms

Identifiers

PMID37801052
PMCPMC11357833
OpenAlexW4387393187

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.