UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059314 |
|---|---|
| Receipt number | R000067847 |
| Scientific Title | Implementing Proactive Referral from Health Checkups to Pharmacies and Smoking Cessation Clinics through Healthcare Provider Intervention: A Single-Arm Feasibility Trial |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/07 21:40:07 |
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Basic information
Public title
Proactive referral for Pharmacies and Smoking Cessation Clinics
Acronym
Proactive referral for Pharmacies and Smoking Cessation Clinics
Scientific Title
Implementing Proactive Referral from Health Checkups to Pharmacies and Smoking Cessation Clinics through Healthcare Provider Intervention: A Single-Arm Feasibility Trial
Scientific Title:Acronym
Proactive referral for Pharmacies and Smoking Cessation Clinics
Region
| Japan |
Condition
Condition
Smokers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to assess the feasibility of implementing proactive referral from health checkups to pharmacies and smoking cessation clinics through an intervention for healthcare providers. The intervention is intended to enable smokers who wish to quit to access cessation support at pharmacies or treatment at clinics. There is currently no evidence of proactive referral between health checkup settings and pharmacies. The primary outcome is the proportion of smokers who make appointments with pharmacies or clinics for smoking cessation support/treatment as a result of proactive referral from health checkup facilities, as an indicator of feasibility.
In this study, proactive referral is defined as the role of healthcare providers at health checkup facilities who, after providing brief smoking cessation support, take responsibility for connecting
individuals wishing to quit smoking to healthcare settings for smoking cessation support and/or treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Penetration of pharmacy/clinic appointments for smoking cessation: The proportion of smokers who make appointments with pharmacies or clinics for smoking cessation support/treatment as a result of proactive referral from health checkup facilities.
Key secondary outcomes
1. Proportion of smokers who make appointments (by pharmacies or smoking cessation clinics)
2. Proportion of smokers who receive cessation support/treatment (overall/by pharmacies or smoking cessation clinics)
3. Success in smoking cessation (overall/by pharmacies or smoking cessation clinics)
4. Acceptability and appropriateness of proactive referral for smoking cessation
5. Fidelity to proactive referral for smoking cessation (overall/by item)
6. Implementation cost of proactive referral for smoking cessation (time/cost)
7. Acceptability and appropriateness of smoking cessation support/treatment
8. Implementation of smoking cessation support/treatment
9. Implementation cost of smoking cessation support/treatment (time/cost)
10. Perceived delivery, appropriateness, self-efficacy, value, importance, barriers and facilitators, and feasibility regarding the implementation of proactive referral for 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 induce healthcare professionals to provide proactive referral in a health check-up setting
1. Conduct training sessions on smoking cessation support
2. Provide guides for proactive referral
3. Provide a proactive referral checksheet
4. Hold a kickoff meeting and request a kickoff report
5. Request a review meeting and report on the meeting
6. Hold 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 Seirei Social Welfare Community
2. Staff providing smoking cessation support at the health check-up center participating in this study
3. Public health nurses, nurses, or dietitians
4. Consent to participate in this study
Key exclusion criteria
Not applicable
Target sample size
20
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 | Megumi |
| Middle name | |
| Last name | Yamashita |
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
meyamas3@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Medical University
Seirei Social Welfare Community
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
| 2025 | Year | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067847
