UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of Decision aiding model which obtain cooperation of the husbands for breast cancer patients receiving initial treatment
Title of the study (Brief title)	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	Chiemi Onishi
Organization	Tokushima university Graduate School of Biomedical Sciences
Division name	Preservation of health science
Address	3-18-15, Kuramotocho, Tokushima-shi ,Tokushima-ken,japan
TEL	088-633-9026
Email	conish@medsci.tokushima-u.ac.jp

Public contact
Name of contact person	Yuki Ichimiya
Organization	Tokushima University Hospital
Division name	Nursing
Address	2-50-1, Kuramotocho, Tokushima-shi ,Tokushima-ken,japan
TEL	088-633-7457
Homepage URL
Email	y.ichimiya@kangotoku.jp

Sponsor
Institute	Tokushima University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038012