UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034861
Receipt No. R000039510
Scientific Title WAROTEMAE 2018 Study
Date of disclosure of the study information 2018/11/12
Last modified on 2018/12/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title WAROTEMAE 2018 Study
Acronym WAROTEMAE2018
Scientific Title WAROTEMAE 2018 Study
Scientific Title:Acronym WAROTEMAE2018
Region
Japan

Condition
Condition Cancer patients
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 clarify the effect of repetition of the opportunity of "laugh" on the immune function and the quality of life (QOL) indicator of cancer patients .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immune function
Key secondary outcomes QOL indicator

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Presence of opportunities for "laughter" by rakugo and comic characters once every 10 days (2 times in total)
Interventions/Control_2 Absence of opportunities for "laughter" by rakugo and comic characters
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Diagnosed with cancer
2. Age 40-65 years old
3. Performance status ECOG 0-1
Key exclusion criteria 1. Incomprehension to questionnaires
2. Illiterate
3. Lack of continuity
Target sample size 60

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 Sponsorship received from companies or donations received from companies etc.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 11 Month 12 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 No longer recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 12 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 11 Month 12 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039510

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.