UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045960 |
|---|---|
| Receipt number | R000052170 |
| 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) |
| Date of disclosure of the study information | 2021/11/03 |
| Last modified on | 2021/11/02 15:53:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yuka.t17m@gmail.com
Sponsor or person
Institute
ChibaNishi General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052170
