Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061115) titled 'A Multicenter, Prospective Observational Study of Symptom Reporting in Patients with Chronic Myeloid Leukemia (CML) Using a Digital Tool' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Saitama Medical University

Condition: Condition - Chronic Myeloid Leukemia Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the feasibility and acceptability of a digital solution designed to address key clinical challenges in the management of chronic myeloid leukemia (CML), including assessment of non-hematologic symptoms, patient quality of life (QOL), and medication adherence. We will utilize an electronic patient-reported outcome (ePRO) tool (YaDoc_CML Symptom Report) implemented within the online disease management system YaDoc. Adult patients with CML receiving tyrosine kinase inhibitor (TKI) therapy will use this tool for a defined period. The primary evaluation includes usage rate and patient satisfaction. In addition, healthcare providers will complete questionnaires to assess feasibility and acceptability in clinical practice. The overall evaluation will be conducted from both patient and healthcare provider perspectives. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1 Patients aged over 18 years at the time of informed consent. 2 Patients who are able to understand the study and provide written informed consent. 3 Smartphone users (iOS version 15.7 or later, Android OS version 8.0 or later, 9.0 or later recommended), excluding unsupported devices (e.g., RakuRaku smartphones, Simple smartphones, iPod Touch iPad mini, iPhone 6 or earlier models, Microsoft Surface devices, all Android tablets, and certain Android smartphones such as HUAWEI devices). 4 Patients with chronic myeloid leukemia (CML) who receive tyrosine kinase inhibitor (TKI) therapy at participating institutions between October 1, 2026, and September 30, 2027. Key exclusion criteria - 1 Patients who have difficulty understanding or operating YaDoc and/or a smartphone. 2 Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators. Target Size - 210

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 30 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069770

Disclaimer: Curated by HT Syndication.