UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013238 |
|---|---|
| Receipt number | 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 13:53:45 |
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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
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
tanimuki@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015449
