Tokyo, Sept. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062774) titled 'Study of an automated pegfilgrastim delivery device and its impact on time and financial burden in patients receiving chemotherapy' on Sept. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Showa Medical University Yokohama Northern Hospital
Condition:
Condition - Breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to characterize the real-world use of an automated pegfilgrastim delivery device (BodyPod) in Japan and to quantitatively evaluate its convenience from the perspectives of time toxicity and financial toxicity. By comparing patient characteristics and patterns of hospital visits across three geographic settings (urban, intermediate, and rural areas), we will examine the impact of regional characteristics on the reduction of patient burden. As a secondary objective, we will also evaluate the potential benefits of the device in older patients.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1 Patients who received pegfilgrastim between January 1, 2023 and August 31, 2025.
2 Healthcare professionals (physicians, nurses, and pharmacists) at participating institutions who have experience with pegfilgrastim administration.
Key exclusion criteria - Recipients of public assistance.
Target Size - 1600
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 17 Day
Anticipated trial start date - 2026 Year 10 Month 20 Day
Last follow-up date - 2028 Year 02 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071838
Disclaimer: Curated by HT Syndication.
