UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032104 |
|---|---|
| Receipt number | R000036587 |
| Scientific Title | Evaluation of the Breast Cancer Patient Support System Application Softwere for Breast Cancer Patients on Drug Therapies. |
| Date of disclosure of the study information | 2018/04/04 |
| Last modified on | 2020/04/08 11:56:51 |
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Basic information
Public title
Evaluation of the Breast Cancer Patient Support System Application Softwere for Breast Cancer Patients on Drug Therapies.
Acronym
BPSS study
Scientific Title
Evaluation of the Breast Cancer Patient Support System Application Softwere for Breast Cancer Patients on Drug Therapies.
Scientific Title:Acronym
BPSS study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate preliminary the BPSS application in regards improving self-management capability, communication skill in patient-health care workers,which could lead to better QOL
Basic objectives2
Others
Basic objectives -Others
To probe preliminarily the usefulness of BPSS application for breast cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HADS as known as Hospital anxiety and depression scale
Key secondary outcomes
HRQOL(EQ-5D),health lieteracy (HLS-14)
, the number of ADR records(items,frequency,severity), App addherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
BPSS application
Interventions/Control_2
without BPSS application(conventional support)
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
Female
Key inclusion criteria
Breast cancer outpatients on the first line antheracycline-/taxane-based chemotherapies
Patients who hope to participate in this study
Key exclusion criteria
Patients with cognitive dysfunction or too severe physical condition
Inability to read and write Japanese
Patients who are not familiar with smartphone or tablet computer
Unavailable internet facility for BPSS use
Patients considered by primary doctors as inappropriateness of participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Handa |
Organization
Showa University
Division name
School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8440
shanda@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Handa |
Organization
Showa University
Division name
School of Pharmacy
Zip code
1428555
Address
1-5-8 Hatanodai, Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8440
Homepage URL
shanda@pharm.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHOWA University Clinical Research Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku Tokyo 142-8555
Tel
0337848129
ura-ec@ofc.showa-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
| 2018 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.clinical-breast-cancer.com/article/S1526-8209(20)30020-3/fulltext
Number of participants that the trial has enrolled
102
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
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EQ-5D-5L was excluded from end-point without license of its application for the tablet use.
Management information
Registered date
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036587
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
