UMIN-CTR Clinical Trial

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
Email	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
Email	miwa_keisuke@kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048019