UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Psychometric Property of Japanese version of Patient Reported Outcome - Common Terminology Criteria for Adverse Event
Title of the study (Brief title)	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	Kanako Azuma
Organization	Tokyo Medical University Hospital
Division name	Department of Pharmacy
Address	160-0022, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3342-6111
Email	azuma-k@tokyo-med.ac.jp

Public contact
Name of contact person	Tempei Miyaji
Organization	The University of Tokyo
Division name	Department of Clinical Trial Data Management, Graduate School of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, JAPAN
TEL	03-5800-9086
Homepage URL
Email	tmiyaji@m.u-tokyo.ac.jp

Sponsor
Institute	Division of Biostatistics, Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017505