UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038937 |
|---|---|
| Receipt number | R000044391 |
| Scientific Title | Feasibility study of healthcare management using mobile application to gynecology malignant patients. |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2023/12/26 18:15:39 |
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Basic information
Public title
Feasibility study of healthcare management using mobile application to gynecology malignant patients.
Acronym
Feasibility study of healthcare management using mobile application to gynecology malignant patients.
Scientific Title
Feasibility study of healthcare management using mobile application to gynecology malignant patients.
Scientific Title:Acronym
Feasibility study of healthcare management using mobile application to gynecology malignant patients.
Region
| Japan |
Condition
Condition
Gynecologic malignancy patients
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility of mobile application for management of gynecologic malignancy patients healthcare.
Basic objectives2
Others
Basic objectives -Others
Validation of correlation between application and results of vital signs and/or results of blood and urine exmanination.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Possibility of collecting datas related to healthcare management using mobile application.
Key secondary outcomes
To assess whether consciousness for healthcare and QOL will be changed by using mobile application.
To explore factors that are strongly related to improvement of patients' QOL.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Patient who;
1) understand research contents and give a written consent.
2) are diagnosed as a gynecologic malignancy in the department of obstetrics and gynecology in Kyoto University Hospital.
3) are over 18 years old.
4) have mobile application and use application named "Calomeal".
Key exclusion criteria
Patient who;
1) cannot understand research contents and cannot express their own opinions well.
2) are diagnosed as a metastatic gynecologic malignancy.
3) cannot use mobile application.
4) Those who suffer with serious life-threatening complications.
5) are considered to be ineligible for enrolling the study by a principal investigator or sub-investigator.
6) withdraw their agreement.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of gynecology and obstetrics
Zip code
606-8507
Address
54 shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
0757513269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of gynecology and obstetrics
Zip code
606-8507
Address
54 shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
0757513269
Homepage URL
soulken@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University, Department of gynecology and obstetrics
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Kyoto University, Department of gynecology and obstetrics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Certified Review Board
Address
Yoshida-Konoe-cho, Sakyo-ku,Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
C1458
Org. issuing International ID_1
Kyoto University Certified Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 20 | 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
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is an observational study.
Management information
Registered date
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044391
| 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 |
