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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042936
Receipt No. R000048964
Scientific Title EORTC-QLQ-HN43 feasibility study
Date of disclosure of the study information 2021/01/08
Last modified on 2021/01/07

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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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