N/A Completed N=94 Supportive Care

The EMPATHY Pilot Study

leukemia · Cancer

Source: ClinicalTrials.gov NCT04384848 ↗

Enrolled (actual)

Serious AEs

13.8%

Results posted

Mar 2024

Primary outcomePrimary: Medication Adherence — 7.81 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Medication Adherence	7.81	—
PRIMARY Number of Participants Adherent To Their Medication	86	—
SECONDARY Health-Related Quality of Life	81.4	—
SECONDARY Fatigue	41.9	—
SECONDARY Cytogenetic Response	61	—

Eligibility Criteria

Inclusion Criteria

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:

1)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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04384848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.