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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028174
Receipt No. R000032259
Scientific Title Development of decision support system based on Nursing Model for Supporting Shared Decision Making for cancer patient
Date of disclosure of the study information 2017/08/01
Last modified on 2019/01/11

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Basic information
Public title Development of decision support system based on Nursing Model for Supporting Shared Decision Making for cancer patient
Acronym Development of decision support system based on NSSDM for cancer patient
Scientific Title Development of decision support system based on Nursing Model for Supporting Shared Decision Making for cancer patient
Scientific Title:Acronym Development of decision support system based on NSSDM for cancer patient
Region
Japan

Condition
Condition Malignancy
Decision Support
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of decision support system based on NSSDM for cancer patient. - choice of treatment, nursing care, medical treatment location etc
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decisional Conflict Scale
Key secondary outcomes The 9-item Shared Decision Making Questionnaire: SDM-Q-9
Health Related Quality of Life Short Form-8
Edmonton Symptom Assessment System Revised Japanese version

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The cancer patients in the control group, nurses make a decision support through counseling of routine
Interventions/Control_2 The cancer patients in the intervention group,nurses make a decision support through decision support system based on NSSDM
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
80 years-old >
Gender Male and Female
Key inclusion criteria cancer patient
cancer patient facing decision-making
Key exclusion criteria Patients who can not be described to understand the contents of the questionnaire
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuko Kawasaki
Organization University of Hyogo
Division name College of Nursing
Zip code
Address 13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL 0789259437
Email yuko_kawasaki@cnas.u-hyogo.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yuko Kawasaki
Organization University of Hyogo
Division name College of Nursing
Zip code
Address 13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL 0789259437
Homepage URL
Email yuko_kawasaki@cnas.u-hyogo.ac.jp

Sponsor
Institute University of Hyogo
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 関西電力病院(大阪府)、京都大学医学部付属病院(京都府)、京都第二赤十字病院(京都府)、神戸市立医療センター西市民病院(兵庫県)、国立がん研究センター中央病院(東京都)、国立病院機構豊橋医療センター(愛知県)、市立大津市民病院(滋賀県)、潤和会記念病院(宮崎県)、信州大学医学部附属病院(長野県)、順天堂大学医学部附属練馬病院(東京都)、手稲渓仁会病院(北海道)、日本医科大学武蔵小杉病院(神奈川県)、三重大学医学部附属病院(三重県)、

Other administrative information
Date of disclosure of the study information
2017 Year 08 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
2017 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 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
2017 Year 07 Month 11 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032259

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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