UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011529 |
|---|---|
| Receipt number | R000013483 |
| Scientific Title | Pilot-testing of the Japanese version of EORTC QLQ-OH17 |
| Date of disclosure of the study information | 2013/08/21 |
| Last modified on | 2014/09/11 14:10:05 |
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Basic information
Public title
Pilot-testing of the Japanese version of EORTC QLQ-OH17
Acronym
Pilot-testing of the Japanese version of EORTC QLQ-OH17
Scientific Title
Pilot-testing of the Japanese version of EORTC QLQ-OH17
Scientific Title:Acronym
Pilot-testing of the Japanese version of EORTC QLQ-OH17
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to linguistically validate Japanese versions of the EORTC QLQ-OH17.
Basic objectives2
Others
Basic objectives -Others
The aim is to identify and solve any potential problems in translation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes associated with this study include the ability for the EORTC QLQ-OH17 to be used in Japan with confidence that the Japanese items are translated correctly and are culturally meaningful and appropriate.
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
1. Receiving concurrent chemotherapy or up to 3 years post treatment.
Key exclusion criteria
1. Multiple primary tumor
2. Severe psychiatric disorder
3. Linguistic difficulty preventing patients from completing the questionnaires.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuhiro Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kawaguchi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Practical Pharmacy
Zip code
Address
1432-1 Horinouchi, Hachioji, Tokyo, Japan
TEL
042-676-1521
Homepage URL
tkawa@toyaku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Division of Biostatistics
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University Hospital
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
| 2013 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Administering the translated questionnaire to 15 patients
2. Conducting structured interviews with each patient individually
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013483
