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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034719
Receipt No. 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 2019/05/08

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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 Panasonic Health Insurance Organization
Division name Panasonic Health Care Center
Zip code 570-8540
Address 5-55 Sotojima-cho, Moriguchi-city, Osaka
TEL 06-6992-7070
Email makiko.kanai@jp.panasonic.com

Public contact
Name of contact person
1st name Makiko
Middle name
Last name Kanai
Organization Panasonic Health Insurance Organization
Division name Panasonic Health Care Center
Zip code 5708540
Address 5-55 Sotojima-cho, Moriguchi-city, Osaka
TEL 06-6992-7070
Homepage URL
Email makiko.kanai@jp.panasonic.com

Sponsor
Institute Panasonic Health Insurance Organization
Institute
Department

Funding Source
Organization Panasonic Health Insurance Organization
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 Panasonic Health Insurance Organization
Address 5-55 Sotojima-cho, Moriguchi-city, Osaka
Tel 06-6992-7070
Email ogawa.masaki001@jp.panasonic.com

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 Enrolling by invitation
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 12 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
2018 Year 10 Month 31 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039282

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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