UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037068 |
|---|---|
| Receipt number | R000042238 |
| Scientific Title | Effectiveness of combined support group program for breast cancer patients with children |
| Date of disclosure of the study information | 2019/06/14 |
| Last modified on | 2022/12/20 11:16:34 |
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Basic information
Public title
Effectiveness of combined support group program for breast cancer patients with children
Acronym
Effectiveness of combined support group program for breast cancer patients with children
Scientific Title
Effectiveness of combined support group program for breast cancer patients with children
Scientific Title:Acronym
Effectiveness of combined support group program for breast cancer patients with children
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a combined support group program for breast cancer patients with children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess changes in QOL before and after the combined support group program for breast cancer patients with children
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
support group
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1)breast cancer patient with children
2)outpatient
3)patient who get permission of medical doctor
4)patient who agree the participation to this study after enough understanding
Key exclusion criteria
1)patient undergoing psychiatric services
2)patient can not communication with Japanese
3)patient who do not have devices that can connect to the Internet
4)patient already in other support groups
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Hashizume |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences (Health Sciences)
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
TEL
+81958197915
hkaori@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Hashizume |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences (Health Sciences)
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
TEL
+81958197915
Homepage URL
hkaori@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagaasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
Tel
+81958197229
gaibushikin@ml.nagasaki-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
| 2019 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 06 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042238
