UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042081 |
|---|---|
| Receipt number | R000048019 |
| Scientific Title | Patient Satisfaction Survey of Portable Disposable Infusion Pumps |
| Date of disclosure of the study information | 2020/10/12 |
| Last modified on | 2021/04/12 15:39:31 |
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Basic information
Public title
Patient Satisfaction Survey of Portable Disposable Infusion Pumps for Colorectal Cancer Chemotherapy
Acronym
Patient Satisfaction Survey of Portable Disposable Infusion Pumps
Scientific Title
Patient Satisfaction Survey of Portable Disposable Infusion Pumps
Scientific Title:Acronym
Patient Satisfaction Survey of Portable Disposable Infusion Pumps
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examining patient preferences for portable infuser pumps
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with unresectable advanced recurrent colorectal cancer
2) Patients undergoing chemotherapy requiring a portable infuser pump
3) Patients with cognitive ability to answer questionnaires
4 )Patients who gave informed consent in writing
Key exclusion criteria
1) Patients under 20 years
2) Patients receiving chemotherapy that does not require a portable infuser pump
3) Patients judged by the principal investigator and the research coordinator to be inappropriate as research subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Miwa |
Organization
Kurume University Hospital
Division name
Multidisciplinary Treatment Cancer Center
Zip code
830-0011
Address
Asahi-machi 67, Kurume, Fukuoka, Japan
TEL
0942-31-7566
miwa_keisuke@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Miwa |
Organization
Kurume University Hospital
Division name
Multidisciplinary Treatment Cancer Center
Zip code
830-0011
Address
Asahi-machi 67, Kurume, Fukuoka, Japan
TEL
0942-31-7566
Homepage URL
miwa_keisuke@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Kurume University Hospital
Address
Asahi-machi 67, Kurume, Fukuoka, Japan
Tel
0942-31-7200
i_rinri@kurume-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
| 2020 | Year | 10 | Month | 12 | 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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective questionnaire survey
Management information
Registered date
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048019
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
