Evaluating Patient-Reported Outcomes Monitoring in Routine Care of Patients with Chronic Myeloid Leukemia for Increasing Adherence and Clinical Response to Therapy, EMPATHY Study

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT04384848
Trial Phases:		Protocol IDs:	NU 19CC07 (primary) NCI-2020-11429
Eligibility:	0 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Northwestern University
NCI Full Details:	http://clinicaltrials.gov/show/NCT04384848

Summary

This clinical trial reviews patients’ experience with an online symptom monitoring system and evaluates its value in improving symptom management, quality of life, adherence to therapy and preliminary treatment outcomes in patients with chronic-phase chronic myeloid leukemia or Philadelphia chromosome positive and/or BRC-ABL positive chronic myeloid leukemia. Knowledge gained from this study may help provide new data on the positive effects of systematically monitoring patient-reported adverse events in routine practice for improving symptom management and adherence to therapy.

Objectives

PRIMARY OBJECTIVES:
I. To develop an online platform for systematic monitoring of patient-reported adverse event (AE) assessment that is tailored to the unique demands of tyrosine kinase inhibitor (TKI) therapy for chronic myeloid leukemia (CML).
II. To assess patient and physician acceptability and satisfaction with use of this platform in CML routine practice and evaluate its value in improving symptom management, health-related quality of life (HRQoL), adherence to therapy as well as preliminary efficacy.

OUTLINE:
Patients complete a series of online surveys over 5-10 minutes at each of their clinic visits for approximately 6 months (a total of 8-10 clinic visits). Patients' medical records are also reviewed.

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