UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015169 |
|---|---|
| Receipt number | R000017505 |
| Scientific Title | Psychometric Property of Japanese version of Patient Reported Outcome - Common Terminology Criteria for Adverse Event |
| Date of disclosure of the study information | 2014/09/21 |
| Last modified on | 2017/05/31 18:10:06 |
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Basic information
Public title
Psychometric Property of Japanese version of Patient Reported Outcome - Common Terminology Criteria for Adverse Event
Acronym
Psychometric Property of Japanese version of Patient Reported Outcome - Common Terminology Criteria for Adverse Event
Scientific Title
Psychometric Property of Japanese version of Patient Reported Outcome - Common Terminology Criteria for Adverse Event
Scientific Title:Acronym
Psychometric Property of Japanese version of Patient Reported Outcome - Common Terminology Criteria for Adverse Event
Region
| Japan |
Condition
Condition
malignancy
Classification by specialty
| Hematology and clinical oncology |
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 PRO-CTCAE.
Basic objectives2
Others
Basic objectives -Others
The primary endpoint is the psychometric property of the Japanese version of PRO-CTCAE.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The psychometric properties, including criterion validity, construct validity, 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. Currently receiving cancer therapy.
2. ECOG PS 0 to 4.
3. Sufficient language ability to understand and complete the questionnaire without assistance.
4. Provision of written informed consent.
Key exclusion criteria
1. Receiving only endocrine therapy.
2. Cognitive impairment.
3. Severe psychiatric disorder.
Target sample size
180
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 | Tempei Miyaji |
Organization
The University of Tokyo
Division name
Department of Clinical Trial Data Management, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, JAPAN
TEL
03-5800-9086
Homepage URL
tmiyaji@m.u-tokyo.ac.jp
Sponsor or person
Institute
Division of Biostatistics, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science, Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama Medical Center, Toshiba General Hospital, Juntendo University Nerima Hospital, Tohoku University Graduate School of Medicine, Tokyo University of Pharmacy and Life Sciences, The University of Tokyo
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（東京都）、埼玉総合医療センター（埼玉県）、東芝病院（東京都）、順天堂大学医附属練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | 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
| 2014 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Each PRO-CTCAE item will be compared between ECOG PS or KPS groups at the Visit 1 and Visit 2. Correlations between each PRO-CTCAE item and the EORTC QLQ-C30 scores will be computed. Correlations and intra-class correlation coefficients (ICC) will be computed for each item assessed on consecutive days (Visit 1 and Visit 1b). Each item of Visit 1 and Visit 2 will be compared.
Management information
Registered date
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017505
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
