UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026831 |
|---|---|
| Receipt number | R000030790 |
| Scientific Title | Initiative On Smile And CAncer |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2019/10/02 15:06:10 |
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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 | Obstetrics 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
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
miyashir@biken.osaka-u.ac.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.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 |
