UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011529
Receipt number R000013483
Scientific Title Pilot-testing of the Japanese version of EORTC QLQ-OH17
Date of disclosure of the study information 2013/08/21
Last modified on 2014/09/11 14:10:05

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Basic information

Public title

Pilot-testing of the Japanese version of EORTC QLQ-OH17

Acronym

Pilot-testing of the Japanese version of EORTC QLQ-OH17

Scientific Title

Pilot-testing of the Japanese version of EORTC QLQ-OH17

Scientific Title:Acronym

Pilot-testing 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 Breast surgery Obstetrics and Gynecology
Oto-rhino-laryngology Orthopedics Urology
Oral surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to linguistically validate Japanese versions of the EORTC QLQ-OH17.

Basic objectives2

Others

Basic objectives -Others

The aim is to identify and solve any potential problems in translation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcomes associated with this study include the ability for the EORTC QLQ-OH17 to be used in Japan with confidence that the Japanese items are translated correctly and are culturally meaningful and appropriate.

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. Receiving concurrent chemotherapy or up to 3 years post treatment.

Key exclusion criteria

1. Multiple primary tumor
2. Severe psychiatric disorder
3. Linguistic difficulty preventing patients from completing the questionnaires.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuhiro Yamaguchi

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Biostatistics

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN

TEL

022-717-7659

Email

yamaguchi@med.tohoku.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

1432-1 Horinouchi, Hachioji, Tokyo, Japan

TEL

042-676-1521

Homepage URL


Email

tkawa@toyaku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine, Division of Biostatistics

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

Tokyo Medical University 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



Other administrative information

Date of disclosure of the study information

2013 Year 08 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

2013 Year 05 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1. Administering the translated questionnaire to 15 patients
2. Conducting structured interviews with each patient individually


Management information

Registered date

2013 Year 08 Month 20 Day

Last modified on

2014 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013483


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name