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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035817
Receipt No. R000040805
Scientific Title Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/08

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Basic information
Public title Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients
Acronym Communication on prognostic disclosure
Scientific Title Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients
Scientific Title:Acronym Communication on prognostic disclosure
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore if the addition of worst/bast cases on the median and typical range and/or hope/prepare statement can convey compassion, decrease anxiety, and clinician trust on prognostic disclosure.
To explore if slow rather than rapid communication can convey compassion, decrease anxiety, and clinician trust on prognostic disclosure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Physician Compassionate Score
Key secondary outcomes Six basic emotions
Anxiety
Clinician trust

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Verbal:
Best/Worst cases +/-
Interventions/Control_2 Verbal:
Hope/Prepare statement +/-
Interventions/Control_3 Non-verbal:
Neither Best/Worst nor Hope/Prepare statements: Slow/rapid
Interventions/Control_4 Non-verbal:
Both Best/Worst and Hope/Prepare statements: Slow/rapid
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients of age 20 or older who are receiving care for cancer
Key exclusion criteria Those who did not agree to participate
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Mori
Organization Seirei Mikatahara General Hospital
Division name Department of Clinical Laboratory
Zip code
Address 3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN
TEL 0534361251
Email masanori.mori@sis.seirei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Mori
Organization Seirei Mikatahara General Hospital
Division name Department of Clinical Laboratory
Zip code
Address 3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN
TEL 0534361251
Homepage URL
Email masanori.mori@sis.seirei.or.jp

Sponsor
Institute Seirei Mikatahara General Hospital
Institute
Department

Funding Source
Organization Health, Labour, and Welfare Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 20 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 20 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
2019 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040805

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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