UMIN-CTR Clinical Trial

Basic information
Public title	A pharmacist-delivered smoking cessation program in community pharmacy: A Cluster Randomized Controlled Trial
Acronym	FINE project (R) (Family pharmacist's Intervention for Nicotine Elimination: Refined)
Scientific Title	A pharmacist-delivered smoking cessation program in community pharmacy: A Cluster Randomized Controlled Trial
Scientific Title:Acronym	FINE project (R) (Family pharmacist's Intervention for Nicotine Elimination: Refined)
Region	Japan

Condition
Condition	Smokers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of the pharmacist-delivered smoking cessation program on smoking cessation in community pharmacies
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Quit rate in the last 7 days (self-reported)
Key secondary outcomes	Quit rate in the past 30 days (self-reported) Biochemically confirmed smoking cessation rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	1) Setting the target goal 2) Assessment and counseling for smoking cessation along with medication counseling 3) Regular follow-up by telephone or other means (minimum 6 times) 4) Providing information and Support using newly developed Support materials 5) Explanation and medication counseling of smoking cessation aids
Interventions/Control_2	1)Provision of information using ready-made leaflets and other materials 2)Explanation and guidance on the use of smoking cessation aids 3)Confirmation of no smoking when visiting the office (once)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) People who have a prescription for the treatment of any chronic disease. 2) Person who are expected to visit community pharmacy over 8 weeks 3) Person who agree to receive smoking cessation program
Key exclusion criteria	1) Dementia or psychiatric disorders 2) Allergies or adverse effects with smoking cessation aids 3) Temporomandibular Joint Disorder (in the case of nicotine gum)
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Mitsuko Middle name Last name Onda
Organization	Faculty of Pharmacy, Osaka Medical and Pharmaceutical University
Division name	Department of Social and Administrative Pharmacy
Zip code	569-1094
Address	4-20-1 Nasahara, Takatsuki, Osaka, Japan
TEL	+81-72-690-1059
Email	mitsuko.onda@ompu.ac.jp

Public contact
Name of contact person	1st name Mitsuko Middle name Last name Onda
Organization	Osaka Medical and Pharmaceutical University
Division name	Faculty of Pharmacy
Zip code	569-194
Address	4-20-1 Nasahara, Takatsuki, Osaka, Japan
TEL	+81-72-690-1059
Homepage URL
Email	mitsuko.onda@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Hospital Organization Kyoto Medical Center(Clinical Research Center)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics review Committee of Osaka Medical and Pharmaceutical University
Address	4-20-1 Nasahara, Takatsuki, Osaka, Japan
Tel	+81-72-690-1103
Email	p-kenkyus@ompu.ac.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	2022 Year 01 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	Preinitiation
Date of protocol fixation	2022 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2022 Year 07 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	2021 Year 11 Month 24 Day
Last modified on	2021 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052694