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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040171
Receipt No. R000045786
Scientific Title Verification of usefulness of video explanation tool in prostate biopsy
Date of disclosure of the study information 2020/04/20
Last modified on 2020/04/15

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Basic information
Public title Verification of usefulness of video explanation tool in prostate biopsy
Acronym Verification of usefulness of video explanation tool in prostate biopsy
Scientific Title Verification of usefulness of video explanation tool in prostate biopsy
Scientific Title:Acronym Verification of usefulness of video explanation tool in prostate biopsy
Region
Japan

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

Objectives
Narrative objectives1 For patients with suspected prostate cancer and undergoing a needle biopsy of the prostate, comparison was made between the group in which the doctor orally explained in the conventional manner and the group in which the explanation video was used in combination, and the patient comprehension, patient satisfaction, and explanation time of the doctor Evaluate. We will examine whether it is possible to reduce the burden on doctors and improve patient satisfaction and understanding by using explanatory videos.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comprehension test of prostate biopsy explanation in oral and video explanation groups
Key secondary outcomes Time of explanation about prostate biopsy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Added video description to oral explanation in prostate biopsy Informed consent
Interventions/Control_2 Oral explanation only in Informed consent of prostate biopsy
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
60 years-old <=
Age-upper limit
79 years-old >=
Gender Male
Key inclusion criteria 1) Age 60 to 79
2) Male
3) Patient who undergo prostate needle biopsy
4) PSA is 4-20ng/ml
Key exclusion criteria 1) Patient with PSA of 20 or more, or with metastasis on the image
2) Patient who are under 60 years old or over 80 years old
3) Patient who have ever had a prostate needle biopsy
4) Urinary retention cases
5) Patient who have been diagnosed with dementia
6) Others, patient who the researcher decides to be inappropriate as a research target
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Matsuzaki
Organization Kansai Medical University
Division name Urology and Andrology
Zip code 573-1181
Address 2-5-1 Shi-machi, Hirakata-shi, Osaka
TEL 072-804-0101
Email matsutom@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Matsuzaki
Organization Kansai Medical University
Division name Urology and Andrology
Zip code 573-0084
Address 2-5-1 Shinmachi, Hirakatashi, Osaka
TEL 072-804-0101
Homepage URL
Email matsutom@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization 121

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

IRB Contact (For public release)
Organization Kansai Medical University Hospital, Urology and Andrology
Address 3-11-16 Shinmachi, Hirakatashi, Osaka
Tel 072-804-0101
Email matsutom@hirakata.kmu.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
2020 Year 04 Month 20 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
2020 Year 03 Month 01 Day
Date of IRB
2020 Year 03 Month 31 Day
Anticipated trial start date
2020 Year 05 Month 08 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
2023 Year 12 Month 31 Day
Date trial data considered complete
2023 Year 12 Month 31 Day
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 04 Month 15 Day
Last modified on
2020 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045786

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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