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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026831
Receipt No. R000030790
Scientific Title Initiative On Smile And CAncer
Date of disclosure of the study information 2017/04/03
Last modified on 2019/10/02

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Basic information
Public title Initiative On Smile And CAncer
Acronym iOSACA
Scientific Title Initiative On Smile And CAncer
Scientific Title:Acronym iOSACA
Region
Japan

Condition
Condition Cancer patients or healthcare professionals
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery Chest surgery
Breast surgery Obsterics and gynecology Oto-rhino-laryngology
Urology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Impact of periodic laughter on self-efficacy of cancer patients or healthcare professionals.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Self-efficacy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Periodic laughter
Interventions/Control_2 No periodic laughter
Interventions/Control_3 Periodic laughter (non-randomized, prospective observational study)
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
65 years-old >
Gender Male and Female
Key inclusion criteria Cancer patients:
1. Histologically proven cancer
2. Age 40-65 years old
3. Performance status ECOG 0-2
4. Expected survival time >= 1 year
Healthcare professionals:
1. Permanent staff contact with cancer patients on a daily basis
2. Age 20-65 years old
Key exclusion criteria 1. Incomprehension to questionnaires
2. Illiterate
3. Lack of continuity
Target sample size 155

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
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Osaka International Cancer Institute
Organization
Division
Category of Funding Organization Self funding
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 yamamototaka@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
2017 Year 04 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 122
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
2017 Year 03 Month 31 Day
Date of IRB
2017 Year 03 Month 31 Day
Anticipated trial start date
2017 Year 04 Month 03 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
2017 Year 04 Month 03 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030790

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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