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

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 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


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

Value
https://center6.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