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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name