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Expert System and Family Assisted Interventions for Chinese Smokers

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of California, San Francisco
American Cancer Society
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00714467
  Purpose

In this study, we choose to specifically recruit Chinese, the largest ethnic group of the Asian and Pacific Islander community,2 as an initial step to increase our understanding of the role of family or supportive others in the process of smoking cessation among Asian Americans. We propose the following specific aims for the study:

  1. Examine the effectiveness of proactive recruitment of Chinese smokers into a smoking cessation treatment program through their family or friends.
  2. Test the efficacy of a family assisted intervention using the stages of change approach in promoting smoking cessation in the context of an expert system intervention.
  3. Explore the role of supportive and non-supportive behaviors in relation to both short-term and long-term smoking cessation outcomes in the presence of the expert system intervention.

Condition Intervention
Smoking Cessation
Behavioral: Expert System Only
Behavioral: Family Assisted

MedlinePlus related topics:   Smoking    Smoking Cessation   

ChemIDplus related topics:   BaseLine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   Expert System and Family Assisted Interventions for Chinese Smokers

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • self-report 7-day smoking abstinence [ Time Frame: 12 months, 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-report of at least a 24-hour quit attempt [ Time Frame: 12 months, 18 months ] [ Designated as safety issue: No ]

Enrollment:   1280
Study Start Date:   August 2004
Estimated Study Completion Date:   July 2008
Primary Completion Date:   November 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Expert system (stage-based manual and 3 individualized tailored feedback reports) only for smokers, paired-supporters (family or friend participant) do not receive any study intervention
Behavioral: Expert System Only
expert system intervention only to the smoker participants which includes a stage-based manual and a series of 3 individualized tailored feedback report at baseline, 3, and 6 months. The paired-supporters receive assessments only and no intervention.
2: Experimental
Expert system (stage-based manual and 3 individualized tailored feedback report) to all the smoker participants; a family assisted intervention in a form of a self-help booklet that discusses specific strategies to work with smokers at each stage of change to the paired-supporters
Behavioral: Family Assisted
The smoker participants received an expert system intervention (same intervention for those in the Expert system intervention) which includes a stage-based manual and a series of 3 individualized tailored feedback report at baseline, 3, and 6 months. The paired-supporters will receive a a self-help booklet based on the Transtheoretical Model of Change (TTM) that will aim at teaching the supporters how to use the stages of change framework to apply different strategies that best match with smokers' readiness to quit smoking.

Detailed Description:

Limited empirical data are available on effective intervention approaches targeting Chinese American smokers. The overall goal of this study is to increase our understanding of the role of family or social support in the facilitation of the process of smoking cessation among Chinese smokers. We propose the following specific aims for the study: 1) Examine the effectiveness of proactive recruitment of Chinese smokers into a smoking cessation treatment program through their family or friends; 2) Test the efficacy of a family assisted intervention using the stages of change approach in promoting smoking cessation in the context of an expert system intervention; 3) Explore the role of supportive and non-supportive behaviors in relation to both short-term and long-term smoking cessation outcomes in the presence of the expert system intervention. This study will develop a family-assisted intervention in the form of a self-help booklet based on the Transtheoretical Model of Change (TTM) that will aim at teaching the supporters how to use the stages of change framework to apply different strategies that best match with smokers' readiness to quit smoking. This study will conduct focus groups and a pilot study to pre-test the study intervention and study procedures. The main randomized trial will recruit a total of 800 supporters and 800 smokers who are ethnic Chinese residing in the State of California. Each supporter-smoker pair will be randomly assigned to either 1) the expert system intervention only or 2) the expert system plus family-assisted intervention condition after baseline assessment by mail. All smokers in either condition will receive the expert system intervention. Half of the supporters will receive family-assisted intervention materials. All participants will be assessed at baseline, 3, 6, 12, and 18 months by mail or telephone. It is hypothesized that the expert system plus family-assisted intervention condition will yield significantly higher abstinence rates and higher portions to report quit attempts at follow-ups.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • self-identified ethnic Chinese
  • men and women
  • above age 18
  • can read and speak Chinese or English
  • reside in the State of California at baseline
  • to participate as a supporter, the participant must have a targeted smoker who meet the smoker eligibility criteria who provides consent to participate in the study as a smoker participant
  • to participate as a smoker, the participant must have smoked at least 100 cigarettes in lifetime and have smoked at least 5 cigarettes in the past 7 days, and have a supporter who provides consent to be a supporter participant

Exclusion Criteria:

  • smoker participant currently engage in other smoking cessation programs or efforts
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714467

Locations
United States, California
UCSF Langley Porter    
      San Francisco, California, United States, 94143

Sponsors and Collaborators
University of California, San Francisco
American Cancer Society

Investigators
Principal Investigator:     Janice Tsoh, PhD     University of California, San Francisco    
  More Information


Responsible Party:   University of California San Francisco ( Janice Tsoh, PhD )
Study ID Numbers:   TURSG-03-102-01 PBP, ACS Grant: TURSG-03-102-01 PBP, H10315-21203-07
First Received:   July 9, 2008
Last Updated:   July 9, 2008
ClinicalTrials.gov Identifier:   NCT00714467
Health Authority:   United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
smoking cessation  
Asian  
Chinese American  
family support
social support
stage-based intervention

Study placed in the following topic categories:
Smoking

ClinicalTrials.gov processed this record on September 19, 2008




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