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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012112
Receipt No. 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

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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
Email 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/
Email yuko_kawasaki@cnas.u-hyogo.ac.jp

Sponsor
Institute University of Hyogo
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014159

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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