UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030291 |
|---|---|
| Receipt number | 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 09:32:08 |
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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
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
oga@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034593
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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