UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028174 |
|---|---|
| Receipt number | 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 | 2020/01/21 11:26:56 |
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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
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
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
yuko_kawasaki@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032259
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