UMIN-CTR Clinical Trial

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	Preinitiation
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 02 Month 01 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 01 Month 14 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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