UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021243 |
|---|---|
| Receipt number | R000024506 |
| Scientific Title | A study to identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2021/09/02 09:23:32 |
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Basic information
Public title
A study to identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire
Acronym
A study to identify factor that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire(SELECT BC-CONFIRM-FEEL 2)
Scientific Title
A study to identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire
Scientific Title:Acronym
A study to identify factor that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire(SELECT BC-CONFIRM-FEEL 2)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify factors that affect clinical trial participation and refusal in breast cancer patients by using a questionnaire at the time when we ask them to participate in the trial, SELECT BC-CONFIRM. Then we use the information to make the patients' entry more efficient in our future clinical trials.
Basic objectives2
Others
Basic objectives -Others
Obtain information that can contribute to informed consent in the planning and clinical practice of the future of the clinical trial
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
a comprehensive evaluation of factors that affect the "participation and refusal of the decision-making to the trial, SELECT BC-CONFIRM" with calculation of odds ratios, 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 was carried out as accompanying study of SELECT BC-CONFIRM which was a randomized controlled study conducted in metastatic or recurrent breast cancer patients. Eligible patients were all of those who were asked to participate in SELECT BC-CONFIRM.
Key exclusion criteria
According to the SELECT BC-CONFIRM.
Target sample size
177
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shozo Ohsumi |
Organization
NHO Shikoku Cancer Center
Division name
Department of Breast Oncology
Zip code
Address
160 Kou, Minamiumemoto-machi,Matsuyama City, Ehime Prefecture,Japan
TEL
+81-(0)89-999-1111
sosumi@shikoku-cc.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
03-5287-2636
Homepage URL
http://www.csp.or.jp/
cspor-office@csp.or.jp
Sponsor or person
Institute
SELECT BC-CONFIRM 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 | 29 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We handed a self-administered questionnaire to all study candidated.
SELECT BC-CONFIRM trial
UMIN ID :000005449
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024506
