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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013238
Receipt No. R000015449
Scientific Title The survey for various changes and daily difficulties in patients with breast cancer through their therapeutic process
Date of disclosure of the study information 2014/02/24
Last modified on 2016/10/12

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Basic information
Public title The survey for various changes and daily difficulties in patients with breast cancer through their therapeutic process
Acronym The survey for various changes in patients with breast cancer through their therapeutic process
Scientific Title The survey for various changes and daily difficulties in patients with breast cancer through their therapeutic process
Scientific Title:Acronym The survey for various changes in patients with breast cancer through their therapeutic process
Region
Japan North America

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

Objectives
Narrative objectives1 To investigate the various changes and daily difficulties in patients with breast cancer thought theirs therapeutic process
Basic objectives2 Others
Basic objectives -Others To investigate their status of utilization for psycho-social medical service
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence of changes and difficulties of daily life in patients with breast cancer thought theirs therapeutic process
Key secondary outcomes The prevalence of the status of utilization for psycho-social medical service

Base
Study type Others,meta-analysis etc

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 Male and Female
Key inclusion criteria Patients with breast cancer who consent to this study
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Tanimukai
Organization Osaka University Hospital
Division name Oncology center
Zip code
Address 2-15, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-5111
Email tanimuki@psy.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi tanimukai
Organization Osaka University Hospital
Division name Oncology center
Zip code
Address 2-15, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-5111
Homepage URL
Email tanimuki@psy.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor BC network
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 24 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 Completed
Date of protocol fixation
2014 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Pre-recruitment

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2016 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015449

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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