UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of quality of life (QOL) in patients with solid cancer - Capturing QOL questionnaire data with electronic devices -
Acronym	QOL-eDEV
Scientific Title	Measurement of quality of life (QOL) in patients with solid cancer - Capturing QOL questionnaire data with electronic devices -
Scientific Title:Acronym	QOL-eDEV
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to reveal the characteristics of the QOL measurement data using the electronic devices, followed by the comparison of the conventional survey method using questionnaires and the method using the electronic devices, with respect to the response rate, the obtained score, etc.
Basic objectives2	Others
Basic objectives -Others	o reveal the characteristics of the QOL measurement data using the electronic devices, followed by the comparison of the conventional survey method using questionnaires and the method using the electronic devices, with respect to the response rate, the obtained score, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to reveal the characteristics of the QOL measurement data using the electronic devices, followed by the comparison of the conventional survey method using questionnaires and the method using the electronic devices, with respect to the response rate, the obtained score, etc.
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	Eligibility Criteria: All of the following criteria must be met. 1) Patients with incurable advanced or recurrent non-small cell lung cancer 2) Patients scheduled to begin / being treated with chemotherapy including CDDP-PEM or CBDCA-PEM 3) Patients able to complete both paper and electronic questionnaires by themselves 4) Patients aged 18 years or older who have given consent to this survey
Key exclusion criteria	1) Hospitalized patients at the time of informed consent 2) Patients unable to answer paper- or electronic-questionnaires.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kojiro Shimozuma
Organization	Ritsumeikan University
Division name	College of Life Sciences, Department of Biomedical Sciences
Zip code
Address	Noji-higashi 1-1-1, Kusatsu, Shiga 525-8577 JAPAN
TEL	077-561-2769
Email	no@mail

Public contact
Name of contact person	1st name Middle name Last name Akira Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Clinical Research(CSPOR)
Zip code
Address	Nishi-Waseda1-1-7, Shinjuku-ku, Tokyo 169-0051, Japan
TEL	03-5287-2636
Homepage URL
Email	cspor-office@csp.or.jp

Sponsor
Institute	Public Health Research Foundation
Institute
Department

Funding Source
Organization	National Institute of Public Health
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
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	2018 Year 11 Month 12 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	2018 Year 10 Month 31 Day
Date of IRB	2018 Year 10 Month 31 Day
Anticipated trial start date	2018 Year 11 Month 12 Day
Last follow-up date	2019 Year 02 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2018 Year 11 Month 12 Day
Last modified on	2020 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039751