UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034863
Receipt No. R000039751
Scientific Title Measurement of quality of life (QOL) in patients with solid cancer - Capturing QOL questionnaire data with electronic devices -
Date of disclosure of the study information 2018/11/12
Last modified on 2018/11/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
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
2018 Year 11 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.