UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045766 |
|---|---|
| Receipt number | R000052235 |
| Scientific Title | Reproductive Concerns After Cancer and Support Needs for Japanese Female Study |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/04/22 11:01:22 |
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Basic information
Public title
Reproductive Concerns After Cancer and Support needs for Japanese Female Study
Acronym
RCAC-F-J Study
Scientific Title
Reproductive Concerns After Cancer and Support Needs for Japanese Female Study
Scientific Title:Acronym
RCAC-F-J Study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study to examine the reproductive concerns and support needs for Japanese female cancer survivors.
Basic objectives2
Others
Basic objectives -Others
To validate the Reproductive Concerns After Cancer for Female Scale Japanese version.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Reproductive Concerns After Cancer-Female Scale(RCAC-F Scale)
Key secondary outcomes
Support Needs, Self-efficacy for female cancer survivors, Patient Health Questionnaire-2.
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Tp fulfill all requirements;
1) Six months or more after cancer diagnosis.
2) Female
3) Adult until age 40.
4) Japanese speaking and to access the web questionnaire.
Key exclusion criteria
To fulfill below a condition at least;
1) Not to consent this study.
2) Not to answer Japanese via the web questionnaire.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Motoyoshi |
Organization
St. Marianna University School of Medicine
Division name
Division of Breast & Endocrine Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan
TEL
044-977-8111
ai-motoyoshi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Motoyoshi |
Organization
St. Marianna University School of Medicine
Division name
Division of Breast & Endocrine Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan
TEL
044-977-8111
Homepage URL
ai-motoyoshi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Fertility Preservation
Organization
Division
Category of Funding Organization
Non profit foundation
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 IRB
Address
2-16-1 Sugao, Miyamae-ku, 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
聖マリアンナ医科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | 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
| 2021 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 05 | Month | 31 | Day |
Other
Other related information
Study Design: Non-invasive Observational Study using web questionnaire, Cross-sectional Study.
Management information
Registered date
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052235
