UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053290 |
|---|---|
| Receipt number | R000060819 |
| Scientific Title | Exploring an intervention for healthcare providers to offer proactive referral for online smoking cessation treatment: A single-arm feasibility study in a health check-up setting (N-EQUITY2301) |
| Date of disclosure of the study information | 2024/01/08 |
| Last modified on | 2024/01/22 16:16:30 |
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Basic information
Public title
Proactive referral for online smoking cessation: A feasibility study in a health check-up setting
Acronym
Proactive referral for online smoking cessation: A feasibility study in a health check-up setting
Scientific Title
Exploring an intervention for healthcare providers to offer proactive referral for online smoking cessation treatment: A single-arm feasibility study in a health check-up setting (N-EQUITY2301)
Scientific Title:Acronym
Proactive referral for online smoking cessation: A feasibility study 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 plan to conduct a definitive trial to evaluate whether training healthcare professionals to promote smokers' use of online cessation treatment through proactive referral is effective. The present study aims to establish the feasibility of this definitive trial. Feasibility will be assessed by the extent to which proactive referral occurs as intended after training of healthcare professionals.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fidelity of proactive referral: the proportion of eligible smokers who received the required step of proactive referral
Key secondary outcomes
1. Fidelity of each step of proactive referral
2. Implementation cost of proactive referral
3. Barriers and facilitators, self-efficacy, perceived value, and perceived importance of proactive referral implementation
4. Stages of change of smoking cessation among smokers
5. Acceptability of proactive referral by smokers
6. Appropriateness of proactive referral for smokers
7. Penetration of online smoking cessation treatment
8. Fidelity of online smoking cessation treatment
9. 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 for healthcare professionals to provide proactive referral in a health check-up setting
1. Training for smoking cessation support
2. Provision of a guide for proactive referral
3. Provision of proactive referral check sheet
4. Provision of a flyer for smoking cessation treatment
5. Induction training to implement proactive referral
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 Niigata Association of Occupational Health
2. Public health nurses, nurses, or dietitians
3. Staff for smoking cessation support at the health check-up in the Sado screening center
4. Consent to participate in this study
Key exclusion criteria
Not applicable
Target sample size
10
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
Japan
Other related organizations
Co-sponsor
Niigata University
Aichi Medical University
Japan Association for Development of Community Medicine
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 | 01 | Month | 08 | 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
4
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
| 2023 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | 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 | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060819
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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