UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033487 |
|---|---|
| Receipt number | R000038012 |
| Scientific Title | Development of Decision aiding model which obtain cooperation of the husbands for breast cancer patients receiving initial treatment |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2018/07/24 00:15:45 |
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Basic information
Public title
Development of Decision aiding model which obtain cooperation of the husbands for breast cancer patients receiving initial treatment
Acronym
Development of Decision aiding model which obtain cooperation of the husbands for breast cancer patients receiving initial treatment
Scientific Title
Development of Decision aiding model which obtain cooperation of the husbands for breast cancer patients receiving initial treatment
Scientific Title:Acronym
Development of Decision aiding model which obtain cooperation of the husbands for breast cancer patients receiving initial treatment
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
"The decision support model who has strengthened the husband's participation" is offered targeted for the breast cancer patient who has an early stage medical treatment, and has for the object to consider whether the decisionmaking which this decision support model was convinced is suggested.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DCS,Shared Decision Making9,MAC,Relationship of mutual trust,Emotional acceptance NRS,QOLACD,QOLACDB,resilience,The conjugal degree of satisfaction linear measure,STAI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The nursing support which makes promote psychological support, relationship of mutual trust building and acceptance of conjugal relationship along "the decision support model who has strengthened the husband's participation" is offered.
Interventions/Control_2
Usual nursing intervention is continued in the contrasting grou
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
The nuclear power plant where you announced a name of disease, breast cancer patient.Disease period of breast cancer: I-III periods.I don't ask about the contents of early stage treatment.
Key exclusion criteria
The patient who was strong in a mental collapse, judged a doctor and a foreign nurse technical support continues the struck symptom, and to be necessary and had technical intervention request after an announcement.The person with the difficult agreement merit from the person herself.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiemi Onishi |
Organization
Tokushima university Graduate School of Biomedical Sciences
Division name
Preservation of health science
Zip code
Address
3-18-15, Kuramotocho, Tokushima-shi ,Tokushima-ken,japan
TEL
088-633-9026
conish@medsci.tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Ichimiya |
Organization
Tokushima University Hospital
Division name
Nursing
Zip code
Address
2-50-1, Kuramotocho, Tokushima-shi ,Tokushima-ken,japan
TEL
088-633-7457
Homepage URL
y.ichimiya@kangotoku.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
| 2020 | Year | 03 | Month | 30 | 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
| 2018 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038012
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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