UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056447 |
|---|---|
| Receipt number | R000064502 |
| Scientific Title | Implementation of an intervention for healthcare providers to offer proactive referral for online smoking cessation treatment: A multicenter single-arm trial in a health check-up setting (N-EQUITY2405) |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2025/12/15 12:58:23 |
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Basic information
Public title
Proactive referral for online smoking cessation treatment: An implementation trial in a health check-up setting
Acronym
Proactive referral for online smoking cessation treatment: An implementation trial in a health check-up setting
Scientific Title
Implementation of an intervention for healthcare providers to offer proactive referral for online smoking cessation treatment: A multicenter single-arm trial in a health check-up setting (N-EQUITY2405)
Scientific Title:Acronym
Proactive referral for online smoking cessation treatment: An implementation trial in a health check-up setting
Region
| Japan |
Condition
Condition
Smokers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the effectiveness of a proactive referral on promoting smokers' use of an online smoking cessation treatment in a health check-up setting. Primary endpoint is the proportion of smokers who receive an online smoking cessation treatment within 3 months after the proactive referral provided by the trained healthcare professionals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Penetration of online smoking cessation treatment: the proportion of smokers who receive an online smoking cessation treatment within 3 months after the proactive referral provided by trained healthcare professionals.
Key secondary outcomes
Provider-level outcome
1. Fidelity of proactive referral
2. Fidelity of each step of proactive referral
3. Implementation cost of proactive referral
4. Delivery, self-efficacy, perceived value, perceived importance, and normalization of smoking cessation support
5. Satisfaction with a training session on smoking cessation support
6. Acceptability, appropriateness, and feasibility of proactive referral
7. Determinants that influenced the implementation of proactive referral and that will impact its sustainability
Individual-level outcome
1. Acceptability of proactive referral by smokers
2. Appropriateness of proactive referral for smokers
3. Penetration of online smoking cessation treatment
4. Fidelity of online smoking cessation treatment
5. Smoking cessation
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention by researchers to healthcare professionals to provide proactive referral in a health check-up setting
1. Conduct of training session on smoking cessation support
2. Provision of a guide for proactive referral
3. Provision of a proactive referral checksheet
4. Provision of a flyer on online smoking cessation treatment
5. Conduct of a kickoff meeting and request for a kickoff report
6. Request to conduct a review meeting and report on the meeting
7. Conduct a meeting to share local knowledge
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
1. Staff of the Niigata Association of Occupational Health
2. Public health nurses, nurses, or dietitians
3. Staff providing smoking cessation support at the health check-up center participating in this study
4. Consent to participate in this study
Key exclusion criteria
Not applicable
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Shimazu |
Organization
National Cancer Center Japan
Division name
Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3542-2511
tshimazu@ncc.go.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Yuwaki |
Organization
National Cancer Center Japan
Division name
Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control
Zip code
104-0045
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3542-2511
Homepage URL
kyuwaki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University
Aichi Medical University
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
| 2024 | Year | 12 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064502
