Testing Different Theories of Smoking Cessation: An Inter... | NCT01209897

Studies
Testing Different Theories of Smoking Cessation: An Intervention Study

NCT01209897

Sponsor

University of Hawaii

Status

Completed

Last Update Posted

May 14, 2024Actual

Enrollment

1,826Actual

Phase

Not Applicable

Conditions

Smoking Cessation

Interventions

Smoking cessation booklet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Sep 24, 2010

First Posted Date

Sep 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2024

Last Update Posted Date

May 14, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thaddeus Herzog, Principal Investigator, University of HawaiiPrincipal Investigator

Lead Sponsor

University of HawaiiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The topic of this research is cigarette smoking cessation. We designed four smoking cessation booklets. These booklets are designed for smokers who differ in their motivation to quit smoking. We will compare different ways of matching booklets to smokers who vary in their motivation to quit smoking.

Detailed Description

The topic of the proposed research is adult cigarette smoking cessation. The PI has designed a set of four smoking cessation booklets. These booklets cover different aspects of the smoking cessation process, and are designed to help smokers who differ in their levels of motivation to quit smoking. The purpose of the study is to compare different ways of matching booklets to smokers who vary in their motivation to quit smoking. Adult smokers (N=1,826) will be recruited via newspaper ads, fliers, and possibly other methods, depending on response rates. Participants will enroll in the study by telephoning the research staff in response to the advertisements. The smoking cessation booklets and surveys will be sent via US Mail. Smokers will be assigned randomly to one of three intervention conditions. Participants at baseline will answer a series of survey items regarding their motivation and plans (or lack thereof) for quitting smoking. The three intervention conditions differ in that each employs a different method of matching smokers to one of the four booklets. Essentially, we are comparing different strategies for allocating booklets to smokers. Participants will be surveyed two weeks and two months after receiving their smoking cessation booklet.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,826Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage of Change	Active Comparator	Participant received booklet based on stage of change.	Behavioral: Smoking cessation booklet
Common Sense Model	Experimental	Participant received booklet based on common sense model.	Behavioral: Smoking cessation booklet
Action Model	Active Comparator	Participant received booklet based on the action stage of change.	Behavioral: Smoking cessation booklet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smoking cessation booklet	Behavioral		Action Model Common Sense Model Stage of Change

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Smoking Status	Participants will be asked if they are still smoking cigarettes, or if they have ceased to smoke cigarettes.	two months

Secondary Outcomes

Measure	Description	Time Frame
Motivation to quit smoking	Participants will be asked about the extent to which they are motivated to quit smoking (for example, if they intend to quit smoking or do not intend to quit smoking).	two months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

must be a current smoker who smokes at least three cigarettes per day
must have smoked at least 100 cigarettes in their lifetime.
must be able to read English so that they can read the intervention booklets and complete questionnaires in English.
must have a mailing address so that they can receive booklets and questionnaires in the mail.
must be age 18 or older.
must live in Hawaii

Exclusion Criteria:

not a current smoker
smokes fewer than three cigarettes per day
has not smoked at least 100 cigarettes in their lifetime
cannot read English
has no mailing address
is under 18

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thaddeus A Herzog, Ph. D.	University of Hawaii Cancer Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Hawaii Cancer Center		Honolulu	Hawaii	96813	United States

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation
D012907	Smoking

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided