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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011272
Receipt No. 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 2014/01/06

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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
Middle name
Last name Takuhiro Yamaguchi
Organization Tohoku University Graduate School of Medicine
Division name Division of Biostatistics
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL 022-717-7659
Email yamaguchi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kawaguchi
Organization Tokyo University of Pharmacy and Life Sciences
Division name Department of Practical Pharmacy
Zip code
Address 192-0392, 1432-1 Horinouchi, Hachioji, Tokyo, Japan
TEL 042-676-1521
Homepage URL
Email tkawa@toyaku.ac.jp

Sponsor
Institute Tokyo University of Pharmacy and Life Sciences
Department of Practical Pharmacy
Institute
Department

Funding Source
Organization None
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
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 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
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 No longer recruiting
Date of protocol fixation
2012 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 05 Day
Last follow-up date
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
2014 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012654

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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