UMIN-CTR Clinical Trial

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 Obsterics 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
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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
Email	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
Email	tkawa@toyaku.ac.jp

Sponsor
Institute	Japanese Organisation for Research and Treatment of Cancer
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016179