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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042365
Receipt No. R000048361
Scientific Title Effects of PHR/PRO(Personal Health Record/Patient Reported Outcome) on behavioral change in patients with breast cancer.
Date of disclosure of the study information 2020/11/06
Last modified on 2021/05/11

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Basic information
Public title Effects of PHR/PRO(Personal Health Record/Patient Reported Outcome) on behavioral change in patients with breast cancer.
Acronym Behavioral change in patients with breast cancer by using PHR/PRO.
Scientific Title Effects of PHR/PRO(Personal Health Record/Patient Reported Outcome) on behavioral change in patients with breast cancer.
Scientific Title:Acronym Behavioral change in patients with breast cancer by using PHR/PRO.
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the effects of application-base physical condition recording on QOL of patients with breast cancer who receive adjuvant hormonal therapy.
Basic objectives2 Others
Basic objectives -Others We collect opinions from the patients regarding the operability and visibility of the app.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FACT-B(Functional Assessment of Cancer Therapy-Breast);before starting adjuvant hormonal therapy and 1 month after the use of app.
Key secondary outcomes Adverse events
Adherence
Questionnaire for the use of app

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

Not applicable
Gender Female
Key inclusion criteria Patients receiving first line adjuvant hormonal therapy at Breast Center in Showa University
Key exclusion criteria 1Patients who had received hormonal therapy in the past

2Patients with recurrent breast cancer

3Patients who cannot operate smartphones or tablets
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Seigo
Middle name
Last name Nakamura
Organization Showa University
Division name Department of Breast Surgical Oncology
Zip code 142-8666
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8511
Email breastc@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Okuyama
Organization Showa University
Division name Department of Advanced Cancer Translational Research Institute
Zip code 142-8555
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8511
Homepage URL
Email hiromiok@med.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 The Ethics Committee of Showa University graduate School of Medicine
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel 03-3784-8129
Email m-rinri@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
2020 Year 11 Month 06 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 14
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
2020 Year 07 Month 22 Day
Date of IRB
2020 Year 08 Month 31 Day
Anticipated trial start date
2020 Year 10 Month 07 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

1FACT-B questionnaire(Before starting adjuvant hormonal therapy and 1 month after the use of app)

2Survey the information entered in the app for a month.

Adverse events
Adherence

Management information
Registered date
2020 Year 11 Month 06 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048361

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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