UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014277 |
|---|---|
| Receipt number | R000016179 |
| Scientific Title | Validity and reliability study of the Japanese version of EORTC QLQ-OH17 |
| Date of disclosure of the study information | 2014/06/17 |
| Last modified on | 2021/03/26 14:22:49 |
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Basic information
Public title
Validity and reliability study of the Japanese version of EORTC QLQ-OH17
Acronym
Validity and reliability study of the Japanese version of EORTC QLQ-OH17
Scientific Title
Validity and reliability study of the Japanese version of EORTC QLQ-OH17
Scientific Title:Acronym
Validity and reliability study 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 | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the validity and reliability of the Japanese version of EORTC QLQ-OH17.
Basic objectives2
Others
Basic objectives -Others
The primary endpoint is the psychometric property of the Japanese version of EORTC QLQ-OH17.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The psychometric properties, including criterion validity, construct validity, multi-trait scaling analysis, internal consistency, test-retest reliability, sensitivity, were assessed.
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. Diagnosed with cancer and receiving chemotherapy and / or radiotherapy included upon start of chemotherapy cycle.
2. Sufficient language ability to understand Japanese and to complete the questionnaire without assistance.
3. Witten informed consent
Key exclusion criteria
1. Severe cognitive impairments
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanako Azuma |
Organization
Tokyo Medical University Hospital
Division name
Department of Pharmacy
Zip code
Address
160-0022, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
azuma-k@tokyo-med.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
192-0392, 1432-1 Horinouchi, Hachioji, Tokyo, Japan
TEL
042-676-1521
Homepage URL
tkawa@toyaku.ac.jp
Sponsor or person
Institute
Japanese Organisation for Research and Treatment of Cancer
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
Nippon Medical School Hospital
Keiyu 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
東京医科大学病院（東京）、日本医科大学付属病院（東京）、けいゆう病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 17 | 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
| 2014 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will be included in the cohort assessing test-retest reliability, sensitivity, or both. The EORTC QLQ-C30 and OH-17 will be administered to both cohort, and OHIP-14 to sensitivity cohort.
Management information
Registered date
| 2014 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016179
