UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035238 |
|---|---|
| Receipt number | 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 | 2024/04/06 09:15:25 |
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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 | Obstetrics 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
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
tomoe.koizumi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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, Kameda IVF Clinic Makuhari.
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
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
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
| Delay expected |
Results Delay Reason
Delay for examining the data.
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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | 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
| 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=R000040146
| 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 |
