Evaluating Patient-Reported Outcomes Monitoring in Routine Care of Patients with Chronic Myeloid Leukemia for Increasing Adherence and Clinical Response to Therapy, EMPATHY Study
0 Years and older, Male and Female
NU 19CC07 (primary)
NCI-2020-11429
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.
Eligibility
- PATIENTS: Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis
- PATIENTS: 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
- PATIENTS: 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
- PATIENTS: Written informed consent
- PATIENTS: Written informed consent from patient’s physician as a participant
- PATIENTS: Newly diagnosed chronic phase (CP)-CML patients who are within 4 weeks of first line TKI therapy (anyone of the TKI approved in the United States of America [USA] and Europe, that is: imatinib, dasatinib, nilotinib or bosutinib)
- PATIENTS: Ability to read/converse in English (Northwestern University and Augusta University sites). Ability to read/converse in Italian (GIMEMA Centers)
- PHYSICIANS: Provider of clinical care for patient who meets inclusion criteria for the study
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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