UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012112 |
|---|---|
| Receipt number | R000014159 |
| Scientific Title | Development of Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient |
| Date of disclosure of the study information | 2013/10/23 |
| Last modified on | 2015/10/23 09:45:55 |
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Basic information
Public title
Development of Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient
Acronym
Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient
Scientific Title
Development of Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient
Scientific Title:Acronym
Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient
Region
| Japan |
Condition
Condition
Decision Support
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effects of Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient(choice of treatment, nursing care, medical treatment location etc)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Decisional Conflict Scale
state-trait anxiety inventory
Key secondary outcomes
Change of heart patients
Patient response observed by the Nurse
Decision-making the final content
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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 Web Version Nursing Program for Supporting Shared Decision Making Process with a Cancer Patient
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
patient in need of decision support
Key exclusion criteria
Patients who can not be described to understand the contents of the questionnaire(Decisional Conflict Scale,state-trait anxiety inventory)
Target sample size
100
Research contact person
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
yuko_kawasaki@cnas.u-hyogo.ac.jp
Public contact
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
http://sdminoncology.sub.jp/
yuko_kawasaki@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
順天堂大学医学部附属順天堂医院（東京都）
広島大学病院（広島県）
神戸大学医学部付属病院（兵庫県）
兵庫県立加古川医療センター（兵庫県）
兵庫県立がんセンター（兵庫県）
社会医療法人生長会ベルランド総合病院（大阪府）
大津市民病院（滋賀県）
三井記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 23 | 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
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 23 | Day |
Last modified on
| 2015 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014159
