UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034861
Receipt number R000039510
Scientific Title WAROTEMAE 2018 Study
Date of disclosure of the study information 2018/11/12
Last modified on 2019/10/02 15:05:33

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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 Obstetrics 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 Isao
Middle name
Last name Miyashiro

Organization

Osaka International Cancer Institute

Division name

Cancer Control Center

Zip code

5418567

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 Isao
Middle name
Last name Miyashiro

Organization

Osaka International Cancer Institute

Division name

Cancer Control Center

Zip code

5418567

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 or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



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

IRB, Osaka International Cancer Institute

Address

3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan

Tel

+81-6-6945-1181

Email

rinri01@opho.jp


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

63

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

2018 Year 11 Month 09 Day

Anticipated trial start date

2018 Year 11 Month 12 Day

Last follow-up date

2020 Year 12 Month 31 Day

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

2019 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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