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Name:
UMIN ID:

Recruitment status Enrolling by invitation
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 2021/10/01

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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
Email 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
Email 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
Email 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
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 29 Day
Last modified on
2021 Year 10 Month 01 Day


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


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