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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035238
Receipt No. R000040146
Scientific Title The psychosocial care study for fertility preservation among young adult cancer patients
Date of disclosure of the study information 2018/12/14
Last modified on 2019/06/17

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Basic information
Public title The psychosocial care study for fertility preservation among young adult cancer patients
Acronym Psychosocial care study for fertility preservation
Scientific Title The psychosocial care study for fertility preservation among young adult cancer patients
Scientific Title:Acronym Psychosocial care study for fertility preservation
Region
Japan

Condition
Condition cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Endocrine surgery Breast surgery Obsterics and gynecology
Pediatrics Dermatology Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe the procedure of decision-making of fertility preservation during the period of the first consultation to the decision.
Basic objectives2 Others
Basic objectives -Others observation study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes psychological distress, symptoms of post traumatic stress disorder, depressive and anxiety symptoms
Key secondary outcomes decisional conflict about fertility preservation, stress coping strategies

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 and Female
Key inclusion criteria Participants are eligible if they who aged 20 and more during fertile generation meet the criteria for cancer, and if they have a first consultation appointment of fertility preservation.
Key exclusion criteria Exclusion criteria are to finish the first consultation of fertility preservation, to be unable to fill in the questionnaire, and to refuse to sign the consent form.
Target sample size 200

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 2-16-1 Sugao, Miyamae, Kawasaki City, Kanagawa 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 2168511
Address 2-16-1 Sugao, Miyamae, Kawasaki City, Kanagawa JAPAN
TEL 044-977-8111
Homepage URL
Email tomoe.koizumi@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor The Jikei University School of Medicine, Toho University, Kameda Medical Center, St. Luke's International Hospital
Name of secondary funder(s) None

IRB Contact (For public release)
Organization St. Marianna University School of Medicine
Address 2-16-1 Sugao, Miyamae, Kawasaki City, Kanagawa JAPAN
Tel 044-977-8111
Email kenkyu@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 聖マリアンナ医科大学病院(神奈川県)、東京慈恵会医科大学病院(東京都)、東邦大学大森病院(東京都)、亀田総合病院(千葉県)、聖路加国際病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 14 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
2019 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 06 Month 30 Day
Date trial data considered complete
2022 Year 09 Month 30 Day
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information Informed consent is conducted at the timing of coming to the hospital in order to have first consultation of fertility preservation. Three questionnaires in approximately one month are scheduled as follows; Time 1) Before first consultation, Time 2) After first consultation, and Time 3) at the timing of decision of fertility preservation.

Management information
Registered date
2018 Year 12 Month 13 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040146

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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