UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Physician's desired communication skill at most difficult situaion for a patient and family members
Title of the study (Brief title)	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	Masahiro Nishioka
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
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	Masahiro Nishioka
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 07 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/30508206
Results
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