The EMPATHY Pilot Study

NCT04384848 | Completed Results DMC

• 1 other identifier: 1R21CA230367-01A1
• Study Type: interventional
• Target: 94
• Locations: 2 countries
• Sites: 16

Brief Summary

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.

Conditions

Leukemia, Chronic Myeloid; Cancer

Keywords

Cancer; Leukemia, Chronic Myeloid; Health-Related Quality Of Life; Patient Reported Outcome

Outcome Measures

Primary Outcomes (2)

• Medication Adherence

  Adherence to Refills and Medications Scale (ARMS). The ARMS-7 consists of seven items evaluating adherence to taking medications and refilling prescriptions. Items are rated on a four-point Likert scale ranging between 7 and 28, with higher scores indicating lower medication adherence.

  6 months

• Number of Participants Adherent To Their Medication

  Prescription refill data extracted from hospital pharmacy records. Prescription refill data were evaluated over 6 months. Missed refills, for reasons other than mortality or physician change of medication, were counted as non-adherence. Adherence was defined as the number of days medicine not available between each refill over the number of days between first prescription and last refill during the study period.

  6 months

Secondary Outcomes (3)

• Health-Related Quality of Life

  6 months

• Fatigue

  6 months

• Cytogenetic Response

  6 months

Study Arms (1)

Chronic myeloid leukemia (CML) patients

EXPERIMENTAL

CML patients undergoing first-line tyrosine kinase inhibitor (TKI) therapy

Other: EMPATHY Pilot

Interventions

EMPATHY Pilot OTHER

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.

Chronic myeloid leukemia (CML) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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).

You may not qualify if:

• 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.
• Please note that Physician consent is requisite for the Patient to be enrolled as a participant in the study.
• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator
• Fondazione GIMEMA: collaborator
• Augusta University: collaborator

Study Sites (16)

Augusta University, Hematology and Oncology

Augusta, Georgia, 30912, United States

Location

Northwestern University, Robert H. Lurie Comprehensive Cancer Center Comprehensive Cancer Center (RHLCCC)

Chicago, Illinois, 60611, United States

Location

Policlinico Sant'Orsola Malpighi - UOC Ematologia - Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Location

Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO - Azienda Ospedaliera G. Brotzu

Cagliari, Italy

Location

Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - UOC Oncoematologia - Padiglione Marcora

Milan, Italy

Location

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - UOC Ematologia

Napoli, Italy

Location

Azienda Ospedaliera Universitaria Maggiore della Carità di Novara - SCDU Ematologia

Novara, Italy

Location

AUSL Reggio Emilia - Arcispedale S. Maria Nuova, IRCSS - SC Ematologia

Reggio Emilia, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università degli Studi "Sapienza" - UOC Ematologia

Roma, Italy

Location

Ospedale Sant'Eugenio

Roma, Italy

Location

The GIMEMA Foundation (Italian Group for Adult Hematologic Diseases)

Rome, 00161, Italy

Location

Azienda Ospedaliero-Universitario Città della Salute e della Scienza di Torino - Ospedale S. Giovanni Battista Molinette - SC Ematologia

Torino, Italy

Location

Ospedale Mauriziano Umberto I - Torino - SCDU Ematologia

Torino, Italy

Location

ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica

Udine, Italy

Location

Azienda Ospedaliera Universitario Integrata di Verona, Policlinico G.B. Rossi - UOC Ematologia

Verona, Italy

Location

USL 6 - Ospedale San Bortolo - Vicenza

Vicenza, Italy

Location

Related Publications (35)

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Related Links

• FACIT Searchable Library and Custom Form Developer (Build-a-PRO)
• EORTC Quality of Life Group Item Library

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Cella
• Organization: Northwestern University

d-cella@northwestern.edu

312-503-1725

Study Officials

• David Cella, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Fabio Efficace, PhD

  Fondazione GIMEMA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical Social Sciences; Feinberg School of Medicine

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: May 12, 2020
• Study Start: November 1, 2019
• Primary Completion: June 10, 2022
• Study Completion: July 31, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-02

Locations

IT (14); US (2)