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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035499
Receipt No. R000039613
Scientific Title A study of laughter by comic robots
Date of disclosure of the study information 2019/01/10
Last modified on 2019/01/09

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Basic information
Public title A study of laughter by comic robots
Acronym laughter by comic robots
Scientific Title A study of laughter by comic robots
Scientific Title:Acronym laughter by comic robots
Region
Japan

Condition
Condition Cancer patinets
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Cardiology
Pneumology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Radiology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether comic robots with automatic creation of manzai script can entertain cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number and duration of smile
Key secondary outcomes Mental health condition by self-written questionnaire

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Appreciation of improvised manzai strips by comic robots.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Diagnosed with cancer
2. Age 20 years and over
Key exclusion criteria Difficult to answer on self-administered questionnaire
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Miyashiro, MD
Organization Osaka International Cancer Institute
Division name Cancer Control Center
Zip code
Address 3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL +81-6-6945-1181
Email miyashir@biken.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Miyashiro, MD
Organization Osaka International Cancer Institute
Division name Cancer Control Center
Zip code
Address 3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL +81-6-6945-1181
Homepage URL
Email miyashir@biken.osaka-u.ac.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
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 01 Month 10 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
2018 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 21 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 01 Month 09 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039613

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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