UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041258 |
|---|---|
| Receipt number | R000047091 |
| Scientific Title | A single-arm feasibility trial of workplace tobacco control programs using a workplace checklist |
| Date of disclosure of the study information | 2020/07/30 |
| Last modified on | 2025/02/28 06:00:40 |
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Basic information
Public title
Workplace interventions to promote tobacco control: a feasibility trial using a workplace checklist
Acronym
Workplace interventions to promote tobacco control: a feasibility trial
Scientific Title
A single-arm feasibility trial of workplace tobacco control programs using a workplace checklist
Scientific Title:Acronym
A single-arm feasibility trial of workplace tobacco control programs
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of workplace tobacco control programs in small or medium-sized companies
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Employer fidelity to the checklist items at 6 months after the intervention
Key secondary outcomes
- Acceptability of the intervention program: employer satisfaction at 6 months after the intervention
- Feasibility of the intervention program: number of consultations during the intervention
- Implementation outcome: implementation scores of tobacco control at 6 months after the intervention
- Process outcome: response rate of the employees survey at the baseline
- Health behavior outcomes: proportion of employees who visited smoking cessation clinics at 6 months after the intervention, proportion of employees who quit smoking at 12 months after the intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The interventionist will offer support to the employers and health managers to adopt and implement the following three evidence-based tobacco control measures: (1) smoke-free workplace, (2) financial assistance on smoking cessation, and (3) incentive schemes. In order to provide support tailored to the needs of the company, the interventionist will propose behavioral change techniques to the employers and health managers during the consultations based on their responses to the workplace checklist. The intervention period will be of 6 months. Consultations will be held approximately once a week in the first month followed by once every 1-3 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for companies
1) A small or medium-sized company or a branch or business office of a company, with 10 or more and 300 or fewer employees
2) Existence of a physical building, wherein the employees work
3) In business for more than 3 years
4) Assent of the employer (branch or office manager) to promote tobacco control
Inclusion criteria for intervention targets
Employers
1) The employer (branch or business manager) of the company participating in the trial
Health managers
1) Employees responsible and actually working for management and promotion of health issues at the workplace
2) The person identified by the employer as the primary health manager (in case of two or more health managers)
Inclusion criteria for observation targets
1) Adult employees aged 20 years or older
2) Employees who belong to companies that agree to participate in the trial
Key exclusion criteria
None
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Shimazu |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Behavioral Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3547-5201
tshimazu@ncc.go.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Saito |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Behavioral Sciences
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3547-5201(ext.3319)
Homepage URL
jsaito@ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2020 | Year | 07 | Month | 30 | 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
142
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the difficulty in ensuring time and effort for writing the manuscript as the next definitive trial had started immediately.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2020 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047091
