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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030291
Receipt No. R000034593
Scientific Title Support on making the choice for early stage prostate cancer patients
Date of disclosure of the study information 2017/12/08
Last modified on 2019/12/09

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Basic information
Public title Support on making the choice for early stage prostate cancer patients
Acronym Support on making the choice for early stage prostate cancer patients
Scientific Title Support on making the choice for early stage prostate cancer patients
Scientific Title:Acronym Support on making the choice for early stage prostate cancer patients
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To provide information to early prostate cancer patients and to support subjective selection of treatment by patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Satisfaction level by questionnaire distributed after receiving doctor's diagnosis of early prostate cancer, degree of comprehension for each treatment method
Key secondary outcomes Importance score of each treatment method selection criterion calculated based on the questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Distribution of pamphlet "Making the choice" describing the condition and treatment of early stage prostate cancer
Interventions/Control_2 No distribution of pamphlet "Making the choice" describing the condition and treatment of early stage prostate cancer
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients diagnosed with early stage prostate cancer
Key exclusion criteria Cases where it is difficult for them to answer the questionnaire themselves

Patients who refuse to participate in the exam
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Katsuhiko
Middle name
Last name Ogasawara
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code 060-0812
Address Sapporo city N12 W5
TEL 011-716-2111
Email oga@hs.hokudai.ac.jp

Public contact
Name of contact person
1st name Katsuhiko
Middle name
Last name Ogasawara
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code 060-0812
Address Sapporo city N12 W5
TEL 011-716-2111
Homepage URL
Email oga@hs.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University, Faculty of Health Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Health Sciences, Hokkaido University
Address N12-W5, Kita-ku, Sapporo
Tel 011-706-3409
Email oga@hs.hokudai.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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 08 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 06 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034593

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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