UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036587