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Testing Different Theories of Smoking Cessation: An Intervention Study (Stage Models)

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ClinicalTrials.gov Identifier: NCT01209897
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : December 13, 2012
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Smoking cessation booklet Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1826 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Testing Alternative Stage Models of Smoking Cessation: An Intervention Study
Study Start Date : February 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Stage of Change Behavioral: Smoking cessation booklet
Experimental: Common Sense Model Behavioral: Smoking cessation booklet
Active Comparator: Action Model Behavioral: Smoking cessation booklet


Outcome Measures

Primary Outcome Measures :
  1. Smoking Status [ Time Frame: two months ]
    Participants will be asked if they are still smoking cigarettes, or if they have ceased to smoke cigarettes.


Secondary Outcome Measures :
  1. Motivation to quit smoking [ Time Frame: two months ]
    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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209897


Locations
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Thaddeus A Herzog, Ph.D. University of Hawaii Cancer Research Center
More Information

Responsible Party: Thaddeus Herzog, Ph.D., Cancer Research Center of Hawaii
ClinicalTrials.gov Identifier: NCT01209897     History of Changes
Other Study ID Numbers: R01CA120799-02 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by University of Hawaii:
Smoking