UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049930 |
|---|---|
| Receipt number | R000054317 |
| Scientific Title | Validation of Quality of Life Interview Scale (SEIQoL) online |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 10:40:32 |
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Basic information
Public title
Validation of Quality of Life Interview Scale (SEIQoL) online
Acronym
Validation of Quality of Life Interview Scale
Scientific Title
Validation of Quality of Life Interview Scale (SEIQoL) online
Scientific Title:Acronym
Validation of SEIQoL online
Region
| Japan |
Condition
Condition
healthy population; cancer patients
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test the reliability and validity of the SEIQoL scale in cancer patients.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to test the responsivility of the SEIQoL scale in cancer patients.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of Life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Stress Management Program
Interventions/Control_2
Usual care
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with cancer within 5 years; who is able to operate a computer, tablet, etc. on their own; who have no difficulty in reading and writing Japanese.
Key exclusion criteria
Patients who are judged by their doctor to have difficulty participating in the program.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Ichikura |
Organization
Kitasato University School of Allied Health Sciences
Division name
Department of Health Science
Zip code
252-0373
Address
1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8031
ichikura@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichikura |
| Middle name | |
| Last name | Kanako |
Organization
Kitasato University School of Allied Health Sciences
Division name
Department of Health Science
Zip code
252-0373
Address
1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8031
Homepage URL
ichikura@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Kanako Ichikura
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Medical and Dental University; Tokyo Metropolitan Ohtsuka Hospital; Edogawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
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
東京医科歯科大学病院／都立大塚病院／江戸川病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 28 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054317
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
