UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041932 |
|---|---|
| Receipt number | 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 | 2024/04/06 09:17:19 |
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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
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Orthopedics |
| Urology |
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
| Other |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
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
| 1st name | Tomoe |
| Middle name | |
| Last name | Koizumi |
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 or person
Institute
St. Marianna University School of Medicine,
Department of Obstetrics and Gynecology,
2-1-16 Sugao, Miyamae, Kawasaki, JAPAN
Institute
Department
Personal name
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
| 2020 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Now data collecting.
Management information
Registered date
| 2020 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047859
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
