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
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
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
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
