UMIN-CTR Clinical Trial

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

Public contact
Name of contact person	1st name Yuko Middle name Last name Kawasaki
Organization	University of Hyogo
Division name	College of Nursing
Zip code	673-8588
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	University of Hyogo
Address	13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
Tel	0789259437
Email	yuko_kawasaki@cnas.u-hyogo.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	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	Completed
Date of protocol fixation	2017 Year 05 Month 19 Day
Date of IRB	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2020 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	2017 Year 07 Month 11 Day
Last modified on	2020 Year 01 Month 21 Day

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