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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032104
Receipt No. 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 2019/08/19

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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
Email 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
Email shanda@pharm.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
Email 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
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 No longer recruiting
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

Management information
Registered date
2018 Year 04 Month 04 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.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


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