UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034863 |
|---|---|
| Receipt number | 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 | 2020/11/12 17:05:02 |
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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
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
cspor-office@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039751
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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