UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052107 |
|---|---|
| Receipt number | R000058037 |
| Scientific Title | Observational study for care planning establishment for the hair loss with the chemotherapy |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/03/06 10:14:34 |
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Basic information
Public title
Observational study for care planning establishment for the hair loss with the chemotherapy
Acronym
OSCAR trial
Scientific Title
Observational study for care planning establishment for the hair loss with the chemotherapy
Scientific Title:Acronym
OSCAR trial
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of various appearance care on the quality of life (QOL) of patients who have hair loss due to chemotherapy for cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in psychological aspects between the support group and non-support group of the reprobeauty-carelist.
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
Postoperative patients before or during or immediately after chemotherapy
Key exclusion criteria
- do not wish to participate in the study
- cannot use smartphones
Target sample size
690
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hojo |
Organization
Saitama Medical Center
Division name
Department of Breast Care
Zip code
3500495
Address
1981 kamoda, kawagoeshi, Saitama 350-8550, Japan
TEL
0492283464
tahojo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hojo |
Organization
Saitama Medical Center
Division name
Department of Breast Care
Zip code
350-8550
Address
1981 kamoda, kawagoeshi, Saitama 350-8550, Japan
TEL
0492283464
Homepage URL
tahojo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical Center
Address
1981 kamoda, kawagoeshi, Saitama 350-8550, Japan
Tel
0492283464
tahojo@saitama-med.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
| 2023 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
- Questionnaire research started from 2022/10/6
- Protocol revision on 2023/7/6
- Registration completed and analysis in progress
Management information
Registered date
| 2023 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058037
