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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037068
Receipt No. 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 2020/06/15

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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
Email 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
Email hkaori@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042238

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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