UMIN-CTR Clinical Trial

Basic information
Public title	EORTC-QLQ-HN43 feasibility study
Acronym	EORTC-QLQ-HN43 feasibility study
Scientific Title	EORTC-QLQ-HN43 feasibility study
Scientific Title:Acronym	EORTC-QLQ-HN43 feasibility study
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore the feasibility in assessing quality of life in the patients with head and neck cancer via internet.
Basic objectives2	Others
Basic objectives -Others	field survey
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Response rate for the questionnaires in T1.
Key secondary outcomes	Response rate for the questionnaires in T2, the number of rasopnded questions, the number of missing data, reason for the missing data.

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) diagnosis of head and neck cancer 2) age 20 year or more 3) receiving chemotherapy at outpatient 4) able to connect internet 5) written informed consent 6) prognosis 3 months or more
Key exclusion criteria	1) patient whom physician regard as inappropriate for joining this study 2) unable to QOL questionnaire
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Ishiki
Organization	National Cancer Center Hospital
Division name	Department of Palliative Medicine
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	0335422511
Email	ishiki-tky@umin.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Ishiki
Organization	National Cancer Center Hospital
Division name	Department of Palliative Medicine
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	0335422511
Homepage URL
Email	ishiki-tky@umin.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of National Cancer Center
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel	0335422511
Email	none

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	2021 Year 01 Month 08 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2021 Year 01 Month 07 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048964

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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