UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011272 |
|---|---|
| Receipt number | R000012654 |
| Scientific Title | Reliability and validity of Japanese version of Control Preferences Scale and Information Needs Questionnaire |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2021/03/26 14:15:53 |
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Basic information
Public title
Reliability and validity of Japanese version of Control Preferences Scale and Information Needs Questionnaire
Acronym
Reliability and validity of Japanese version of Control Preferences Scale and Information Needs Questionnaire
Scientific Title
Reliability and validity of Japanese version of Control Preferences Scale and Information Needs Questionnaire
Scientific Title:Acronym
Reliability and validity of Japanese version of Control Preferences Scale and Information Needs Questionnaire
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the reliability and validity of Control Preferences Scale and Information Needs Questionnaire.
Basic objectives2
Others
Basic objectives -Others
Psychometric property of Control Preferences Scale and Information Needs Questionnaire
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychometric property of Control Preferences Scale and Information Needs Questionnaire
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
1. Diagnosed as breast cancer.
2. Under chemotherapy or endocrine therapy more than 1 month from initiation of treatment.
3. Able to fill in the questionnaires by him/herself.
Key exclusion criteria
1. Cognitive disorder, agitation or delirium
2. Severe psychiatric disorder
3. Patients judged inappropriate for this study by the health care provider
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
980-8577
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kawaguchi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Practical Pharmacy
Zip code
192-0392
Address
192-0392, 1432-1 Horinouchi, Hachioji, Tokyo, Japan
TEL
042-676-1521
Homepage URL
tkawa@toyaku.ac.jp
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Department of Practical Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Pharmacy and Life Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Breast Oncology, Tokyo Medical University Hospital
Department of Pharmacy, Tokyo Medical University Hospital
Nagumo Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Hospital
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
Tel
03-3342-6111
IRB@tokyo-med.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
東京医科大学病院（東京都）、ナグモクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 05 | 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
50
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
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Making a comparison responses of the CPS and semi-structured interviews with patients.
Management information
Registered date
| 2013 | Year | 07 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012654
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
