UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014047 |
|---|---|
| Receipt number | R000016356 |
| Scientific Title | Validation study for ESAS-r Japanese version |
| Date of disclosure of the study information | 2014/05/27 |
| Last modified on | 2014/05/23 10:34:23 |
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Basic information
Public title
Validation study for ESAS-r Japanese version
Acronym
Validation study for ESAS-r Japanese version
Scientific Title
Validation study for ESAS-r Japanese version
Scientific Title:Acronym
Validation study for ESAS-r Japanese version
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ESAS-r Japanese version
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reliability and validity of the ESAS-r Japansese version
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
having opted to receive cancer treatment
Key exclusion criteria
demonstrating no serious physical or psychological distress as recognized by the attending physicians or researchers.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
National Cancer Center Hospital East
Division name
Psycho-Oncology Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-7013
asogawa@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
National Cancer Center Hospital East
Division name
Psycho-Oncology Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-7013
Homepage URL
asogawa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison between ESAS-r and MDASI-J
Management information
Registered date
| 2014 | Year | 05 | Month | 23 | Day |
Last modified on
| 2014 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016356
