UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness and Challenges of Counseling Programs for Smoking Cessation
Acronym	Effectiveness and Challenges of Counseling Programs for Smoking Cessation
Scientific Title	Effectiveness and Challenges of Counseling Programs for Smoking Cessation
Scientific Title:Acronym	Effectiveness and Challenges of Counseling Programs for Smoking Cessation
Region	Japan

Condition
Condition	smoking
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Testing the effectiveness of a counseling program for smoking cessation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stages of Smoking Cessation Enthusiasm to quit smoking Self-efficacy" regarding quitting smoking Behavioral change" related to smoking Cognitive change" regarding smoking
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	cognitive behavioral therapy
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	Smoking
Key exclusion criteria	not applicable
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Suzuki Middle name Last name Junya
Organization	ADVANTAGE Risk Management Co., Ltd.
Division name	Advantage Counselling Center
Zip code	161-0032
Address	16F Nakameguro GT Tower, Kamimeguro 2-1-1, Meguro-ku Tokyo
TEL	0357736145
Email	jsuzuki@armg.jp

Public contact
Name of contact person	1st name Suzuki Middle name Last name Junya
Organization	ADVANTAGE Risk Management Co., Ltd.
Division name	Advantage Counselling Center
Zip code	161-0032
Address	16F Nakameguro GT Tower, Kamimeguro 2-1-1, Meguro-ku Tokyo
TEL	0357736145
Homepage URL
Email	jsuzuki@armg.jp

Sponsor
Institute	ADVANTAGE Risk Management Co., Ltd.
Institute
Department

Funding Source
Organization	ADVANTAGE Risk Management Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ADVANTAGE Risk Management Co., Ltd.
Address	16F Nakameguro GT Tower, Kamimeguro 2-1-1, Meguro-ku Tokyo
Tel	0357736145
Email	jsuzuki@armg.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 08 Month 21 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 08 Month 21 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2024 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	2022 Year 08 Month 21 Day
Last modified on	2022 Year 08 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055505