UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040171 |
|---|---|
| Receipt number | 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 | 2023/10/19 16:04:00 |
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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
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
matsutom@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
84
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
Completed
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
| 2022 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 22 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 22 | 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
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045786
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/04/18 | PRT_cyosahyou_研究計画書 - 改ver1.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/04/18 | ビデオ説明 データ収集済み20230414.xlsx |
