UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021098 |
|---|---|
| Receipt number | R000024337 |
| Scientific Title | Factor of the questionnaire that affect the clinical trial participation and Refusal in breast cancer patients |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2021/08/24 13:26:33 |
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Basic information
Public title
Factor of the questionnaire that affect the clinical trial participation and Refusal in breast cancer patients
Acronym
Factor of the questionnaire that affect the clinical trial participation and Refusal in breast cancer patients (SELECT BC-FEEL)
Scientific Title
Factor of the questionnaire that affect the clinical trial participation and Refusal in breast cancer patients
Scientific Title:Acronym
Factor of the questionnaire that affect the clinical trial participation and Refusal in breast cancer patients (SELECT BC-FEEL)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To recruit subjects of SELECT BC, conduct a questionnaire survey of the factors that affect the decision-making of participation and refusal. It is possible reflected in the future of informed consent, the collection of information that leads to the patient registration.
Basic objectives2
Others
Basic objectives -Others
Obtain information that can contribute to informed consent in the planning and actual medical of the future of the clinical trial.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The factors that affect the "participation and refusal of the decision-making to the SELECT BC" a comprehensive evaluation from the results of the odds ratio, stratified analysis and multivariate analysis.
Key secondary outcomes
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
This study was carried out as accompanying research of SELECT BC is a randomized controlled study in metastatic or recurrent breast cancer patient, to target all patients who received the participation description of the SELECT BC.
Key exclusion criteria
Conform to the exclusion criteria of the SELECT BC.
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Mukai |
Organization
National Cancer Center Hospital East
Division name
Division of Breast and Medical Oncology
Zip code
Address
6-5-1, Kasiwanoha, Kashiwa-shi, Chiba-ken, 227-8577, Japan
TEL
04-7133-1111
hrmukai@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Clinical Research
Zip code
Address
Nishiwaseda1-1-7, Shinjyuku-ku Tokyo, 169 -0051 Japan
TEL
03-5287-2633
Homepage URL
http://www.csp.or.jp/
cspor-office@csp.or.jp
Sponsor or person
Institute
SELECT BC executive committee
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 19 | 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
| 2009 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 11 | Month | 02 | Day |
Other
Other related information
Perform a self-administered questionnaire to all participants.
SELECT BC trial UMIN ID:C000000416
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024337
