UMIN-CTR Clinical Trial

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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