UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034719 |
|---|---|
| Receipt number | R000039282 |
| Scientific Title | Prospective study on factors affecting smoking cessation support for workers |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2019/10/31 15:17:18 |
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Basic information
Public title
Prospective study on factors affecting smoking cessation support for workers
Acronym
Prospective study on factors affecting smoking cessation support for workers
Scientific Title
Prospective study on factors affecting smoking cessation support for workers
Scientific Title:Acronym
Prospective study on factors affecting smoking cessation support for workers
Region
| Japan |
Condition
Condition
nicotine dependency
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors that affect the usefulness of smoking cessation support in the workplace
Basic objectives2
Others
Basic objectives -Others
To investigate the effect of heat-not-burn tobacco on health and smoking behavior
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
continuous abstinence rate for 1 year
Key secondary outcomes
Body Weight, Body composition
annual medical examination
PHQ-9 score
CAT score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Smoking cessation support program in the workplace
1 Varenicline: 12 weeks, 5 visits
2 Nicotine replacement therapy: 8 weeks, 3 counseling
4 group therapy
5 lung function test
6 education
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among smokers in the workplace, those who agree to participate in the study after enough explanation about the study
Key exclusion criteria
1 Patients who do not agree
2 Those who have difficulty in continuing research participation due to severe side effects etc
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Kanai |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto city
TEL
0756419161
makiko-kanai@umin.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Kanai |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto city
TEL
075-641-9161
Homepage URL
makiko_kanai@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto city
Tel
0756419161
makiko_kanai@umin.ac.jp
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 | 10 | Month | 31 | 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 | 15 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039282
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
