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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041932 |
Receipt No. | R000047859 |
Scientific Title | The evaluation study of the psychoeducational video for young adult male cancer patients with cryopreserved sperm |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2021/01/14 |
Basic information | ||
Public title | The evaluation study of the psychoeducational video for young adult male cancer patients with cryopreserved sperm | |
Acronym | The evaluation study of the psychoeducational video for young adult male cancer patients with cryopreserved sperm | |
Scientific Title | The evaluation study of the psychoeducational video for young adult male cancer patients with cryopreserved sperm | |
Scientific Title:Acronym | The evaluation study of the psychoeducational video for young adult male cancer patients with cryopreserved sperm | |
Region |
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Condition | |||||
Condition | cancer | ||||
Classification by specialty |
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Classification by malignancy | Malignancy | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To produce a psychoeducational video on medical and psychosocial information and disclosure communication for male cancer patients with cryopreservation of sperm, and to evaluate the video in the point of fertility-related knowledge level, decisional regret, and self-efficacy. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Fertility-related knowledge level. |
Key secondary outcomes | Decisional regret and self-efficacy. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | Psychoeducational video. | |
Interventions/Control_2 | Usual information. | |
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 |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | The inclusion criteria of the study are male cancer patients aged 20 or more years, who have already finished sperm cryopreservation. | |||
Key exclusion criteria | Potential subjects with any of the following are excluded from this study declined to participate in the study or did not complete the questionnaire. | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | St. Marianna University School of Medicine | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | 216-8511 | ||||||
Address | 2-1-16 Sugao, Miyamae, Kawasaki, JAPAN | ||||||
TEL | 044-977-8111 | ||||||
nao@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | St. Marianna University School of Medicine | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | 216-8511 | ||||||
Address | 2-1-16 Sugao, Miyamae, Kawasaki, JAPAN | ||||||
TEL | 044-977-8111 | ||||||
Homepage URL | |||||||
tomoe.koizumi@marianna-u.ac.jp |
Sponsor | |
Institute | St. Marianna University School of Medicine,
Department of Obstetrics and Gynecology, 2-1-16 Sugao, Miyamae, Kawasaki, JAPAN |
Institute | |
Department |
Funding Source | |
Organization | The Research for Promotion of Cancer Control Programs, Health Labour Sciences Research Grant, #H29-Cancer Control-General-008, #20EA0401, by the Japanese Ministry of Health, Labour, and Welfare. |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | JAPAN |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | St. Marianna University School of Medicine |
Address | 2-1-16 Sugao, Miyamae, Kawasaki, JAPAN |
Tel | 044-977-8111 |
k-sienbu.mail@marianna-u.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 |
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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 | |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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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=R000047859 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |