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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | prostate cancer | |
Classification by specialty |
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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 |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 | |
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Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 |