UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032720
Receipt number 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 14:42:24

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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 or person

Institute

Nagoya City University

Institute

Department

Personal name



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

Value
https://center6.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