UMIN-CTR Clinical Trial

Basic information
Public title	A Clinical Study of Electronic Patient Outcome to Enhance Pharmacists' Support for Patients with Nausea and Vomiting induced Chemotherapy (Collaborative Study with Community Pharmacy)
Acronym	A Clinical Study of Electronic Patient Outcome to Enhance Pharmacists' Support for Patients with Nausea and Vomiting induced Chemotherapy (Collaborative Study with Community Pharmacy)
Scientific Title	A Clinical Study of Electronic Patient Outcome to Enhance Pharmacists' Support for Patients with Nausea and Vomiting induced Chemotherapy (Collaborative Study with Community Pharmacy)
Scientific Title:Acronym	A Clinical Study of Electronic Patient Outcome to Enhance Pharmacists' Support for Patients with Nausea and Vomiting induced Chemotherapy (Collaborative Study with Community Pharmacy)
Region	Japan

Condition
Condition	CINV chemotherapy induced nausea and vomiting
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine clinical usefulness of electronic patients diary directed CINV management for improving self-care agency of patients and strengthening relationships with nearby pharmacy
Basic objectives2	Others
Basic objectives -Others	usefulness of electronic patients diary
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	usefulness of electronic patients diary
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Have the CINV symptom input for 2 cycle by using electronic patient's diary
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 undergoing hospitalization or outpatient chemotherapy 2.Patient who is 20 years old or more and can enter smartphone or personal computer 3.Patient who signed, based on his/her free will, to the clinical trial agreement with full understanding of the purpose of this conducted trial and its insights
Key exclusion criteria	patients deemed unsuitable as subjects
Target sample size	20

Research contact person
Name of lead principal investigator	1st name yuka Middle name Last name nakamura
Organization	ChibaNishi General Hospital
Division name	Pharmacy
Zip code	270-2251
Address	107-1 Kanegasaku, Matsudo-shi, Chiba-ken
TEL	047-384-8111
Email	yuka.t17m@gmail.com

Public contact
Name of contact person	1st name yuka Middle name Last name nakamura
Organization	ChibaNishi General Hospital
Division name	pharmacy
Zip code	270-2251
Address	107-1 Kanegasaku, Matsudo-shi, Chiba-ken
TEL	047-384-8111
Homepage URL
Email	yuka.t17m@gmail.com

Sponsor
Institute	ChibaNishi General Hospital
Institute
Department

Funding Source
Organization	not selected
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	ain pharmacy chibanishi
Name of secondary funder(s)

IRB Contact (For public release)
Organization	mirai iryo research center
Address	Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	03-3263-8195
Email	yuka.t17m@gmail.com

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	2021 Year 11 Month 03 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	2021 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 11 Month 10 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 02 Day
Last modified on	2021 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052170