UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062774 |
|---|---|
| Receipt number | R000071838 |
| Scientific Title | Multicenter study on the real-world use of an automated pegfilgrastim delivery device and its impact on patient burden, including time and financial toxicity, in Japan |
| Date of disclosure of the study information | 2026/09/05 |
| Last modified on | 2026/09/01 20:44:35 |
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Basic information
Public title
Study of an automated pegfilgrastim delivery device and its impact on time and financial burden in patients receiving chemotherapy
Acronym
Study on the Use of an Automated Pegfilgrastim Delivery Device and Its Impact on Time and Financial Burden
Scientific Title
Multicenter study on the real-world use of an automated pegfilgrastim delivery device and its impact on patient burden, including time and financial toxicity, in Japan
Scientific Title:Acronym
Multicenter Study of Time and Financial Toxicity Associated with an Automated Pegfilgrastim Delivery Device
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Evaluation of patient burden (time toxicity and financial toxicity) and convenience associated with different methods of pegfilgrastim administration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient burden associated with pegfilgrastim administration (time toxicity and financial toxicity). Time spent for pegfilgrastim administration and direct and indirect costs will be assessed and compared between patients receiving pegfilgrastim by syringe and those using the automated delivery device (BodyPod).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Chishima |
Organization
Showa Medical University Yokohama Northern Hospital
Division name
Department of Breast Surgery
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
chishima-t@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Nana |
| Middle name | |
| Last name | Komatsu |
Organization
Showa Medical University Yokohama Northern Hospital
Division name
Department of Breast Surgery
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
nana.k@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University Yokohama Northern Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Research Involving Human Subjects, Showa Medical University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study comparing pegfilgrastim administered by prefilled syringe with an on-body injector (BODYPOD) in patients with breast cancer. Patient questionnaires, medical record data, and healthcare professional questionnaires will be used to compare patient and healthcare professional burden, healthcare resource utilization, and costs.
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071838
