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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032720
Receipt No. R000037312
Scientific Title Physician's desired communication skill at most difficult situaion for a patient and family members
Date of disclosure of the study information 2018/05/25
Last modified on 2018/12/14

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Basic information
Public title Physician's desired communication skill at most difficult situaion for a patient and family members
Acronym Physician's desired communication skill at most difficult situaion
Scientific Title Physician's desired communication skill at most difficult situaion for a patient and family members
Scientific Title:Acronym Physician's desired communication skill at most difficult situaion
Region
Japan

Condition
Condition terminal delirium
Classification by specialty
Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify physicians' appropriate communication style for family members confronting difficult surrogate decision-making in palliative care setting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physician Compassion Scale after viewing the video
Key secondary outcomes Decisional Conflict Scale, emotions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Viewing the autonomous style video group
Interventions/Control_2 Viewing the paternalistic style video group
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
75 years-old >=
Gender Male and Female
Key inclusion criteria The eligibility criteria for inclusion in this study were 1) medical staff whose working experience of clinical oncology was more than 3 years, and 2) age was older than 20, younger than 75.
Key exclusion criteria The exclusion criteria were a person who was inappropriate to participate to this study judged by authors (ex. possibility of acquaintance of the video performers).
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Nishioka
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601 JAPAN
TEL 052-853-8271
Email nishimasachan@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Nishioka
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601 JAPAN
TEL 052-853-8271
Homepage URL
Email nishimasachan@yahoo.co.jp

Sponsor
Institute Nagoya City University
Institute
Department

Funding Source
Organization Grant-in-Aid for Challenging Exploratory Research from Japanese Society for the Promotion of Science KAKENHI grant JP 15K15172
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Palliative Medicine, Higashi-Osaka Hospital
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 名古屋市立大学病院(愛知県)、東大阪病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30508206
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 Main results already published
Date of protocol fixation
2016 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 25 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037312

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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