CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
EMPATHY Pilotother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04384848
NCT04384848N/ACompleted

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

Northwestern University·interventional·Posted May 12, 2020·Updated Mar 4, 2024

In Brief

A clinical study evaluating EMPATHY Pilot for Leukemia, Chronic Myeloid and Cancer. Completed, enrolled 94 participants across 16 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 12, 2020
Enrollment StartNov 1, 2019
Primary CompletionJun 10, 2022
Study CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.1 years ago

Interventions

EMPATHY Pilotother

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.